WO2011039637A2 - Surfactant-free water-free foamable compositions, breakable foams and gels and their uses - Google Patents
Surfactant-free water-free foamable compositions, breakable foams and gels and their uses Download PDFInfo
- Publication number
- WO2011039637A2 WO2011039637A2 PCT/IB2010/002612 IB2010002612W WO2011039637A2 WO 2011039637 A2 WO2011039637 A2 WO 2011039637A2 IB 2010002612 W IB2010002612 W IB 2010002612W WO 2011039637 A2 WO2011039637 A2 WO 2011039637A2
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- WIPO (PCT)
- Prior art keywords
- oil
- agent
- ppg
- composition
- ether
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- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/08—Vasodilators for multiple indications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q17/00—Barrier preparations; Preparations brought into direct contact with the skin for affording protection against external influences, e.g. sunlight, X-rays or other harmful rays, corrosive materials, bacteria or insect stings
- A61Q17/04—Topical preparations for affording protection against sunlight or other radiation; Topical sun tanning preparations
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q19/00—Preparations for care of the skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q19/00—Preparations for care of the skin
- A61Q19/10—Washing or bathing preparations
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
- A61K2800/20—Chemical, physico-chemical or functional or structural properties of the composition as a whole
- A61K2800/30—Characterized by the absence of a particular group of ingredients
- A61K2800/31—Anhydrous
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
- A61K2800/20—Chemical, physico-chemical or functional or structural properties of the composition as a whole
- A61K2800/30—Characterized by the absence of a particular group of ingredients
- A61K2800/33—Free of surfactant
Definitions
- Foams and, in particular, oleaginous single -phase foams are complicated systems which do not form under all circumstances. Slight shifts in foam composition, such as by the addition of active ingredients or the removal of any of the essential ingredients, may destabilize the foam.
- oleaginous foam compositions require significant amounts of surface active agents to form a foam. These compositions require various standard surfactants, as essential components.
- foam adjuvant includes only native fatty alcohols and fatty acids. These are amphiphatic, and essentially hydrophobic with a minor hydrophilic region. For the purposes of forming an emulsion these foam adjuvants, unlike "standard” or “customary surfactants", are not effective as stand-alone surfactants in foamable emulsion compositions, because of their very weak emulsifying capacity on their own. Fatty alcohols and fatty acids have been loosely described as co-surfactants in foamable emulsion compositions, because they assist customary surfactants to boost foam quality, help evolve the foaming properties and because they stabilize the foam in part because of their property as thickeners.
- the hydrophobic solvents are provided to have an occlusive effect at the target site, for example where the site of treatment is a damaged skin and the occlusive effect of hydrophobic solvents is desirable.
- the application further describes semi solid gel compositions that liquefy on application of mild shear force such as gentle rubbing.
- foams can easily be formulated based on high amounts of water, in combination with surface active agents, foam adjuvants and polymeric agents.
- hydrophobic solvents can have a de-foaming effect which makes the formulation of foams based on hydrophobic solvents challenging, especially in compositions that do not contain water.
- surfactants that act as foaming agents.
- Surface active agents are known to be irritating, especially ionic surface active agents and repeated use can cause dry skin and so it is desirable to reduce their use in pharmaceutical compositions intended to treat skin or mucosa.
- foam adjuvants such as fatty alcohols and fatty acids
- foam stabilizing agents such as foam stabilizing agents
- polymeric agents e.g. gelling agents
- Waxes may also be introduced into these surfactant-based formulations but as will be appreciated, waxes, which are solids at ambient temperature, can easily precipitate.
- the technical problems to be overcome in formulating carriers and pharmaceutical compositions with hydrophobic solvent are multifold and include finding a suitable substitute for surfactant which provides foam generating properties; finding a suitable replacement that preferably does not need to have a foam adjuvant present with the surfactant (substitute), which if present would inter alia help to boost the foam and as an aid to the surfactant and preferably does not need to have a polymeric agent present with the surfactant (substitute), which if present would inter alia help prolong stability of the foam.
- Incorporated in or added to the above is the aspect of how to provide formulations in which unstable active ingredients, such as tetracyclines, which readily degrade can nevertheless remain sufficiently chemically stable for prolonged periods of time such that allowing for a reasonable or acceptable amount of breakdown (for example as may be accepted by a regulatory drug authority) they remain capable of providing a therapeutic effect or prevention or remission of a disorder or disease (hereinafter "chemically stable").
- a further challenge is providing and delivering a composition in which the active agent is homogenous.
- the formulations should avoid the use of substances, which can be irritating if applied to a sensitive target or can cause depletion or drying or soreness on repeated use.
- Incorporated in or added to the above is the aspect of how to provide physically stable formulations which are at least short term stable upon release from the pressurized container and not break as a result of exposure to skin temperature.
- Foams which are structurally stable on the skin for at least one minute are termed "short term stable" carriers or foams.
- the foamable formulation including propellant remains homogenous and does not separate to any significant extent for at least one minute after being shaken (hereinafter "physically stable").
- composition has an acceptable shelf- life of at least 15 months, or at least 18 months or at least 21 months or at least two years at ambient temperature.
- composition which is a single phase.
- a composition which prevents the degradation of the active ingredient upon application on the target site of treatment.
- the drug carrier is formulated for use on sensitive targets such as the eye.
- the active pharmaceutical ingredients are formulated for use on sensitive target areas such as sensitive or damaged skin areas, wounds, burns, mucosal membranes, and body cavities. Hydrophobic solvents that are suitable, for example, for eye treatment or for use in wounds or burns.
- the drug carrier and the respective pharmaceutical composition with an active agent are both formulated for use on sensitive targets such as the eye.
- the composition is intended for use in treatment or prevention of eye infections.
- a substantially surfactant free oleaginous formulation or foam there is provided an essentially surfactant free oleaginous formulation or foam.
- the oleaginous formulations and foams are free of surfactants.
- quality oleaginous formulations and foams can be achieved without the presence of significant amounts of standard polymeric agents (e.g. gelling agents).
- a substantially surfactant-free and substantially polymeric agent-free oleaginous formulation or foam are free of standard surfactants and polymers.
- these formulations and foams can be achieved over a large range of hydrophobic solvent content.
- a safe and effective foamable carrier composition and foam comprising a hydrophobic solvent, an oleaginous foamer complex (also termed "foamer complex”), comprising a first member, comprising about 0.1% to about 20% by weight of a fatty alcohol; and a second member, comprising about 0.1 % to about 20%> by weight of (i) a fatty acid; and/or (ii) a wax; and a liquefied or compressed gas propellant.
- the foamer agent comprises a paraffin wax alone or in combination with the first member and/or the second member.
- the concentration of the propellant is about 3% to about 30% by weight of the total composition.
- the concentration of the propellant is about 1% to about 3%) by weight of the total composition; or about 3% to about 25%; or about 7% to about 17%; or about 10% to about 14%.
- the amount in the formulation may be as little as about 1% by weight of the total composition.
- a safe and effective foamable pharmaceutical or cosmetic composition and foam comprising at least one active agent.
- a safe and effective foamable pharmaceutical or cosmetic composition and foam comprising an effective amount of a pharmaceutical or cosmetic active agent, a hydrophobic solvent, a foamer complex and a liquefied or compressed gas propellant.
- the percent by weight is based on weight foamable composition; where the ratio of composition other than propellant to propellant is from about 100: 1 to about 100:30; or from about 100:3 to about 100:30; or from about 100:4 to about 100:25; or from about 100:7 to about 100: 17; or from about 100: 10 to about 100: 14 or from any one of the lower ratios to any one of the higher ratios.
- compositions comprising a propellant having a vapor pressure between about 10 psi and about 130 psi .
- a composition comprising a propellant which is hydrocarbon propellant or a hydrofluorocarbon or another environmentally acceptable propellant.
- the formulation comprises 0% to about 91% petrolatum and about 4% to about 95% hydrophobic solvent, provided that if present the combined amount of hydrophobic solvent and petrolatum is at least about 60% by weight. In one or more alternative embodiments the formulation comprises 0% to about 95% petrolatum and about 0%) to about 95% hydrophobic solvent, provided that if present the combined amount of hydrophobic solvent and petrolatum is at least about 60% by weight.
- the petrolatum is about 61% to about 70%) and the hydrophobic solvent is about 25% to about 34% provided that the combined amount of hydrophobic solvent and petrolatum is at least about 60% by weight. In certain embodiments the petrolatum is about 61% to about 80% and the hydrophobic solvent is about 15% to about 34% provided that the combined amount of hydrophobic solvent and petrolatum is at least about 60% by weight.
- hydrophobic solvent is about 0.1% to about 14% , provided that the combined amount of hydrophobic solvent and petrolatum is at least about 60% by weight.
- a petrolatum is present the formulation comprises about 1% to about 80% petrolatum and about 15% to about 94% hydrophobic solvent, provided that the combined amount of hydrophobic solvent and petrolatum is at least about 60% by weight.
- petrolatum may be in excess of about 80% (see for example formulation A8 in Table 9, which produced foam of excellent quality.
- a foamable formulation comprising petrolatum in excess of about 80%, optionally a liquid oil, a fatty alcohol, and a wax, wherein the formulation generates quality breakable foam.
- a foamable formulation comprising petrolatum in excess of about 80%, optionally a liquid oil, a fatty alcohol and/or a fatty acid, and/or a wax, wherein the formulation generates quality breakable foam.
- a foamable formulation comprising petrolatum in excess of about 80%, a liquid oil, and at least one of a fatty alcohol and/or a fatty acid, and/or a wax, wherein the formulation generates quality breakable foam.
- the foamable carrier composition forms a breakable foam that is stable, yet breaks easily upon application of shear force.
- the composition is used for intradermal delivery of the active agent into the skin with minimal or negligible transdermal delivery.
- a formulation is provided to achieve intra mucosal delivery.
- the composition provides for transdermal delivery.
- the composition can be used for prevention of a disease or disorder.
- the composition or foam is applied to a target surface or area in or on which prevention is sought.
- the composition or foam is applied to a target surface or area having a dermatological or mucosal disorder in need of treatment.
- the composition or foam is used to treat or ameliorate a dermatological or mucosal disease or disorder.
- it may be used to provide a period of remission from the dermatological or mucosal disease or disorder.
- the one or more active agents is selected from the group consisting of adipic acid, an acaricide, an active herbal extract, an age spot and keratose removing agent, an allergen, an alpha hydroxyl acid, an analgesic agent, an androgen, an anesthetic, an anti wrinkle agent, an antiacne agent, an antiaging agent, an antiallergic agent, an antiandrogen agent, an antiapoptotic agent, an antibacterial agent , an antibiotic, an antibiotic agent, an antiburn agent, an anticancer agent, an antidandruff agent, an antidepressant, an antidermatitis agent, an antiedemic anent, an antifungal agent, an antihelminth agent, an antihistamine, an anti-hyperkeratosis agent, an anti-infective agent, an antiinflammatory agent, an antiirritant, an antilipemic agent, an antimicrobial agent, an antimycotic agent, an antioxidant, an antiparasitic agent,
- chemotherapeutic agent a corticosteroid, a dicarboxylic acid, a dihydrotestosterone inhibitor, a disinfectant, doxycycline, an estrogen, a fungicide, fumaric acid, glycolic acid, a hair growth regulator, a haptene, a herbal extract (comprising an active substance), a hormonal agent, a hormone, a hydroxy acid, an immunogenic substance, an immunomodulator, an
- an immunoregulating agent an immunostimulant, an immunosuppressant, an immunosuppressive agent, an insect repellent, an insecticide, iron oxide, a keratolytic agent, lactic acid, a lactam, lidocaine, a local anesthetic agent, a lubricating agent, a masking agent, a metal, a metal oxide, minocycline, a mitocide, mometasone fuorate, a neuropeptide, a non-steroidal anti-inflammatory agent, an organo-beryllium compound, an organo-metallic compound, an oxidizing agent, and organo-boron compound, a pediculicide, a peptide, a pesticide, a photodynamic therapy agent, a progesterone, a prostaglandin, a protein, a radical scavenger, a refatting agent, a retinoid, a sadative agent, a scabicide, sebacic acid, a sedative,
- the active agent is a tetracycline antibiotic.
- the tetracycline is tetracycline, oxytetracycline, demeclocycline, doxycycline, lymecycline, meclocycline, methacycline, minocycline, rolitetracycline, chlorotetracycline or tigecycline.
- the tetracycline is a mixture of two or more tetracyclines.
- the tetracycline is tetracycline, minocycline or doxycyline or a salt thereof.
- the tetracycline is a hydrophobic tetracyline, selected from minocycline and doxycycline. In one or more embodiments the tetracycline is present in a free base form, a hydrate form, a salt form or a complex form. In one or more embodiments the tetracycline is not soluble or is partially soluble and all or part thereof is suspended in the composition. In certain embodiments the tetracycline is minocycline. In certain embodiments the tetracycline is doxycycline. In one or more embodiments the properties or uses discovered for minocycline can be applied to any tetracycline antibiotic.
- the active agent is selected from a group consisting of mometasone furoate, calcitriol and calciptriol.
- the active agent is a vitamin D derivative or analog.
- the Vitamin D derivative is calcitriol or calcipotriol or the corticosteroid is mometasone furoate.
- the inclusion of two or more therapeutic agents in the foamable pharmaceutical composition is desirable.
- the fatty alcohol is a therapeutically active fatty alcohol.
- the fatty alcohol can be a straight chain fatty alcohol, a saturated fatty alcohol, an unsaturated fatty alcohol, a hydroxyl substituted fatty alcohol or a branched fatty alcohol.
- the fatty alcohol has a carbon chain length of 14 to 22 carbons.
- the foamable composition comprises a fatty acid.
- the fatty acid can be a straight chain fatty acid, a saturated fatty acid, an unsaturated fatty acid, a hydroxyl fatty acid or a branched fatty acid.
- the fatty acid is a therapeutically active fatty acid.
- the fatty acid is stearic acid.
- the foamable composition comprises a wax.
- the wax can be a liquid wax, a solid wax, an animal wax, a vegetable wax, a mineral wax, a natural wax or a synthetic wax.
- the fatty acid is a therapeutically active wax.
- the wax is selected from a list comprising paraffin wax, beeswax, hydrogenated castor oil or mixtures thereof.
- a composition comprising a paraffin wax.
- the paraffin wax can have a melting point from about 37 °C.
- the paraffin wax comprises of alkane chains of between about C20H42 to C 4 ot1 ⁇ 2.
- the alkane chains are substantially straight chain.
- branched or unsaturated molecules can be present. Branched chains are sometimes referred to as isoparaffms.
- the paraffin wax can be selected from the group consisting of paraffin wax 58-62°C, paraffin wax 51-53°C, and paraffin wax 42-44°C, or mixtures thereof.
- other melting point ranges can be selected such as 125°F to 135°F; 127°F to 130°F; 130°F to 135°F; 135°F to 145°F ; 140°F to 145°F; 150°F to 155°F; 150°F to 165°F; 160°F to 165°F; or such as 43-46°C; 46-53°C; 48-50°C; 52-54°C; 53-55°C; 54-57°C; 54-58°C; 58-60°C; 59-61°C; 60-62°C; 62-66°C; 65-68°C; or any other similar or relative range(s) or mixtures thereof.
- the wax comprises a polyolefm. In an embodiment the wax is fully refined. In an embodiment it is suitable for cosmetic use. In an embodiment it is suitable for pharmaceutical use. In an embodiment the paraffin wax is soft In one or more embodiments the wax is a mixture of two or more waxes. In certain embodiments the mixture of waxes comprises hydrogenated caster oil and beeswax. In certain embodiments the ratio of beeswax to hydrogenated castor oil is about or at least 1 : 1. In one or more embodiments the ratio is between about 1 : 1 : to about 1 : 10, or between about 1 : 1 to about 1 :6, or between about 1 : 1 to about 1 :5.
- the ratio of fatty alcohol to wax is between about 4:1 to about 1 :4.
- the foamable composition is physically and chemically stable for at least two and preferably at least three months.
- the foamable composition containing a vitamin D derivative or analog is physically and chemically stable for at least three months.
- the foamable composition containing calcitriol is physically and chemically stable for at least three months.
- the foamable composition containing a corticosteroid is physically and chemically stable for at least three months.
- the foamable composition containing mometasone furoate is physically and chemically stable for at least three months.
- the foamable composition containing a tetracycline is physically and chemically stable for at least three months.
- the foamable composition containing minocyline is physically and chemically stable for at least six months.
- the drug carrier is formulated substantially free of short chain alcohols, such as, ethanol, propanol or butanol. In one or more embodiments the drug carrier is formulated essentially free of short chain alcohols. In one or more specific embodiments the drug carrier is formulated essentially free of fatty alcohols. In one or more specific embodiments the drug carrier is formulated essentially free of derivatives of fatty alcohols or fatty acids. In one or more other specific embodiments the drug carrier is formulated essentially free of polyols. In one or more other specific embodiments the drug carrier is formulated substantially free of surfactants and/or short chain alcohols and/or polyols.
- the drug carrier is formulated essentially free of surfactants and/or short chain alcohols and/or polyols.
- a composition which is essentially waterless.
- a surfactant free composition that is also free of short chain alcohols and/or polyol-free.
- a substantially polymer free composition In other embodiments it is essentially polymer free.
- the composition is free of polymeric agent.
- a polymeric agent has a Molecular weight of at least about 1000 Daltons.
- the composition is essentially free of two or more of water; polymeric agent; surfactant; short chain alcohol; or polyol. In one or more embodiments the composition is essentially free of three or more of water; polymeric agent; surfactant; short chain alcohol; or polyol. In one or more embodiments the composition is essentially free of four or more of water; polymeric agent; surfactant; short chain alcohol; or polyol. In one or more embodiments the composition is essentially free of water; polymeric agent; surfactant; short chain alcohol; and polyol.
- the drug carrier is formulated substantially free of elastomers. In one or more other specific embodiments the drug carrier is formulated essentially free of elastomers. In one or more other specific embodiments the drug carrier is formulated substantially free of silicones. In one or more other specific embodiments the drug carrier is formulated essentially free of silicones. In one or more other specific embodiments the drug carrier is formulated with less than about 30% silicone, or less than about 25% silicone, or less than about 20% silicone, or less than about 15% silicone, or less than about 10% silicone, or less than about 7.5% silicone, or less than about 5% silicone or less than about 2% silicone; or less than about 1% silicone; or less than about 0.5% silicone.
- a substantially surfactant free foamable composition comprising:
- an oleaginous foamer complex comprising:
- percent by weight is based on weight foamable composition; wherein the ratio of composition other than propellant to propellant is from about 100:3 to about 100:30; and wherein upon dispensing the foamable carrier composition forms a breakable foam that breaks easily upon application of shear force.
- a substantially surfactant free composition comprising:
- an oleaginous foamer complex comprising:
- the active agent is compatible with and chemically stable in the composition.
- the active agent is considered chemically stable when more than about 90% of the active agent does not break down after a period of two months in the formulation at room temperature. In one or more embodiments the period is six months. In one or more embodiments more than about 88% of the active agent does not break down. In one or more embodiments the active agent is chemically stable in the composition at 40 °C.
- a method of producing a foamable composition including: 1. providing a foamable therapeutic composition including a therapeutic agent at a therapeutically effective concentration, a hydrophobic solvent, for example, at a concentration of about 60% to about 95% by weight, a foamer complex (including at least two of a fatty alcohol, a fatty acid and a wax);
- a method of preventing, treating ameliorating or eliminating a or alleviating a disease or a disorder by selecting and releasing on to a convenient surface having or anticipated to have a dermatological or mucosal disorder or disease in need of treatment a safe and effective pharmaceutical or cosmetic a substantially surfactant free foamable composition comprising an effective amount of a pharmaceutical or cosmetic agent, a hydrophobic solvent, a foamer complex and a liquefied or compressed gas propellant at a concentration of about 3% to about 30% by weight of the total composition;
- the active agent is a placebo.
- a dermatological or mucosal disorder comprising: applying a substantially surfactant free foamable composition comprising to a surface having a
- composition comprising:
- percent by weight is based on weight foamable composition; wherein the ratio of composition other than propellant to propellant is from about 100:3 to about 100:30; and wherein upon dispensing the foamable carrier composition forms a breakable foam that breaks easily upon application of shear force.
- a substantially surfactant free foamable composition for preventing or treating or alleviating a dermatological or mucosal disorder wherein the disorder or disease is selected from the group(s) consisting of
- gynecological disorders that respond to hormonal therapy, a malignant tumor, a non- dermatological disorder which responds to topical or transdermal delivery of an active agent, a parasitic infection, a pelvic inflammation, a pigmentation disorder, a scaling papular diseases, a sexual dysfunction disorder, a sexually transmitted disease, a vaginal disorder, a viral infection, a vulvar disorder, a vulvovaginal infection, a wound, a yeast infection, abscess, acne, acne conglobata, acne fulminans, acne scars, acne vulgaris, actinic keratosis, acute and chronic salpingitis, acute febrile neutrophilic dermatosis, acute lymphangitis, acute pelvic inflammatory disease, acute soft tissue injury, albinism, allergic contact dermatitis, alopecia, alopecia areata, alopecia totalis, alopecia universalis, an allergy, an anal abscess or fistula, an anal and rec
- premenstrual syndrome pressure sores, pressure ulcers, pressure urticaria, pruritis, pruritus ani, pseudofolliculitis barbae, psoriasis, PUPPP, purpura, pustules, pyogenic granuloma, rash, reactions to sunlight, rectal abscess, rectal fistula, rheumatic pain, ringworm, rosacea, roseola, rubella, salpingitis, scabies, scalded skin syndrome, scaling papular diseases, scarring, scleroderma, sebaceous cyst, seborrheic dermatitis, seborrheic keratoses, seborrheic keratosis, sexual arousal disorder, shingles, skin aging, skin cancer, skin neoplasia, skin neoplasms, skin rash, skin tags, skin ulcers, sports injuries, squamous cell carcinoma, staphylococcal scalde
- the foamable composition for treatment of a disorder, is able to reduce skin photodamage or radiation damage and photoaging, and more generally to reduce oxidative stress and inflammation in skin pathologies which are known to be accompanied by apoptotic cell death.
- the foamable composition comprising minocycline, for treatment of a disorder has properties or activities selected from a list including regenerative, anti-apoptotic, anti-inflammatory, anti-photodamaging, anti-radiation damage and anti-photoaging.
- a composition for use in preventing or ameliorating or treating a disorder the minocycline composition having at least one property or activity selected from a list including regenerative, anti-apoptotic, anti-inflammatory, anti-photodamaging anti-radiation damage and anti-photoaging.
- compositions comprising minocycline for use in preventing, protecting from or ameliorating or treating a disorder with symptoms including increased apoptosis and/or decreased cell viability, where the formulation acts to decrease apoptosis and/or increase cell viability. In one or more embodiments there is provided a composition for use in decreasing apoptosis and/or increasing cell viability.
- the composition should generate a foam of good or excellent quality having low density and small bubble size.
- Stability/Breakability The fine balance between stability and breakability of the foam coming out of the container is very delicate: on one hand the foam should preferably not be “quick breaking", i.e., it should be at least short term stable upon release from the pressurized container and not break as a result of exposure to skin temperature; and on the other hand, it should be "breakable”, i.e., it should spread easily, break down and absorb into the skin or membrane upon application of mild shear force.
- a foamable carrier composition including:
- the foamable composition is suitable for administration to various body areas, including, but not limited to the skin, a body surface, a body cavity, a mucosal surface, e.g., the mucosa of the nose, mouth and eye, the ear, the respiratory system, the vagina or the rectum (severally and interchangeably termed herein "target site").
- a mucosal surface e.g., the mucosa of the nose, mouth and eye, the ear, the respiratory system, the vagina or the rectum (severally and interchangeably termed herein "target site").
- the carrier comprises an active pharmaceutical or cosmetic agent which degrades in the presence of water, and in such cases the presence of water in the composition is clearly not desirable.
- the composition is waterless.
- the active agent may tolerate the presence of a small amount of water and the waterless composition is substantially non-aqueous.
- substantially non-aqueous is intended to indicate that the waterless composition has water content preferably below about 2%, such as, below about 1.5%, below about 1%; or below about 0.5%.
- the formulation may contain low amounts of water of up to about 25%.
- g. foams of excellent quality that did not collapse after 180 seconds at 36°C were obtained with a ratio of fatty alcohol: fatty acid of 1 : 1 and a total concentration of fatty alcohol together with fatty acid ranging from about 7% to about 10%; b) the ratio of beeswax to hydrogenated castor oil; e.g. foams of good quality that did not collapse after 180 seconds at 36°C were obtained with a ratio of beeswax to hydrogenated castor oil of 1 : 1 or more, c) ratio of fatty alcohol to wax e.g. foams of good quality that did not collapse after 180 seconds at 36°C were obtained with a ratio of fatty alcohol to wax of 2:3 to 3:2. d) the type and concentration of propellant e.g. AP-70 and
- the oleaginous formulations of the present invention can provide foams of good quality in the presence of various active ingredients. It was found for example that compositions of the present invention comprising one or more of Doxycycline Hyclate, Betamethasone Valerate, Progesterone, Terbinafme, Metronidazole, Mometasone Furoate, Calcitriol, Calcipotriol and Naproxen can give rise to breakable foams of good to excellent quality which did not collapse for at least 2 minutes at 36°C.
- the active agent is a vitamin A or a derivative or analog thereof.
- the active agent is a vitamin E or a derivative or analog thereof.
- the active agent is a vitamin K or a derivative or analog thereof.
- the active agent is a vitamin F or a derivative or analog thereof.
- the active agent is vitamin D or a derivative or analog thereof.
- the active agent is corticosteroid.
- the active agent is doxycycline hyclate.
- the active agent is betamethasone valerate. [0092] In one or more embodiments, the active agent is progesterone.
- the active agent is terbinafme.
- the active agent is metronidazole.
- the active agent is one or more of doxycycline hyclate, betamethasone valerate, progesterone, terbinafme, metronidazole, mometasone furoate, calcitriol, calcipotriol and naproxen.
- composition is capable of providing intradermal delivery of the active agent into the skin with minimal or negligible transdermal delivery.
- the composition is for use in eye infections.
- the composition is physically and chemically stable for at least two months and wherein the active agent is compatible with and chemically stable in the composition.
- the composition is physically and chemically stable for at least three months and wherein the active agent is compatible with and chemically stable in the composition.
- the composition is physically and chemically stable for at least six months and wherein the active agent is compatible with and chemically stable in the composition.
- the active agent is compatible with and chemically stable in the composition.
- the composition of the present invention comprises at least one hydrophobic organic solvent.
- the hydrophobic organic solvent should be compatible with the active ingredient. Oils which are incompatible are omitted. For example, minocycline compositions will be free of pomegranate seed oil.
- a "hydrophobic organic solvent” (also termed “hydrophobic solvent”) as used herein refers to a material having solubility in distilled water at ambient temperature of less than about 1 gm per 100 mL, more preferably less than about 0.5 gm per 100 mL, and most preferably less than about 0.1 gm per 100 mL. It is liquid at ambient temperature.
- hydrophobic solvent is not intended to characterize the solubilization capabilities of the solvent for any specific active agent or any other component of the foamable composition. Rather, such term is provided to aid in the identification of materials suitable for use as a hydrophobic solvent in the foamable compositions described herein.
- the hydrophobic solvent is present at a concentration of about 60% to about 95% or about 65% to about 90%; or about 70% to about 90% or about 75% to about 85%.
- the composition of the present invention comprises at least one hydrophobic solvent, selected from the group consisting of an oil including a mineral oil, a hydrocarbon oil, an ester oil, a liquid triglyceride oil, an oil of plant origin, an oil from animal origin, an unsaturated or polyunsaturated oil, a diglyceride, a PPG alkyl ether and a silicone oil.
- hydrophobic solvent selected from the group consisting of an oil including a mineral oil, a hydrocarbon oil, an ester oil, a liquid triglyceride oil, an oil of plant origin, an oil from animal origin, an unsaturated or polyunsaturated oil, a diglyceride, a PPG alkyl ether and a silicone oil.
- Non- limiting examples of hydrocarbon oils include mineral oil, liquid paraffin, an isoparaffin, a polyalphaolefin, a polyolefm, polyisobutylene, a synthetic isoalkane,
- ester oils include alkyl benzoate, alkyl octanoate, C12-C15 alkyl benzoate, C12-C15 alkyl octanoate, arachidyl behenate, arachidyl propionate, benzyl laurate, benzyl myristate, benzyl palmitate, bis (octyldodecyl stearoyl) dimer dilinoleate, butyl myristate, butyl stearate, cetearyl ethylhexanoate, cetearyl isononanoate, cetyl acetate, cetyl ethylhexanoate, cetyl lactate, cetyl myristate, cetyl octanoate, cetyl palmitate, cetyl ricinoleate, decyl oleate, diethyleneglycol diethylhexan
- Non-limiting examples of liquid triglycerides and oils of plant origin include alexandria laurel tree oil, avocado oil, apricot stone oil, barley oil, borage seed oil, calendula oil, canelle nut tree oil, canola oil, caprylic/capric triglyceride castor oil, coconut oil, corn oil, cotton oil, cottonseed oil, evening primrose oil, flaxseed oil, groundnut oil, hazelnut oil, glycereth triacetate, glycerol triheptanoate, glyceryl trioctanoate, glyceryl triundecanoate, hempseed oil, jojoba oil, lucerne oil, maize germ oil, marrow oil, millet oil, neopentylglycol
- dicaprylate/dicaprate olive oil, palm oil, passionflower oil, pentaerythrityl tetrastearate, poppy oil, propylene glycol ricinoleate, rapeseed oil, rye oil, safflower oil, sesame oil, shea butter, soya oil, soybean oil, sweet almond oil, sunflower oil, sysymbrium oil, syzigium aromaticum oil, tea tree oil, walnut oil, wheat germ glycerides and wheat germ oil.
- PPG alkyl ethers include PPG-2 butyl ether, PPG-4 butyl ether, PPG-5 butyl ether, PPG-9 butyl ether, PPG- 12 butyl ether, PPG- 14 butyl ether, PPG- 15 butyl ether, PPG- 15 stearyl ether, PPG- 16 butyl ether, PPG- 17 butyl ether, PPG- 18 butyl ether, PPG-20 butyl ether, PPG-22 butyl ether, PPG-24 butyl ether, PPG-26 butyl ether, PPG-30 butyl ether, PPG-33 butyl ether, PPG-40 butyl ether, PPG-52 butyl ether, PPG-53 butyl ether, PPG-10 cetyl ether, PPG-28 cetyl ether, PPG-30 cetyl ether, PPG-50 cetyl ether, PPG-30 isocetyl
- oils from animal origin include herring oil, cod-liver oil and salmon oil.
- the hydrophobic solvent may be an emollient, i.e., a hydrophobic liquid having a softening or soothing effect especially to the skin.
- the liquid oil may contain a solid or semi solid hydrophobic matter at room temperature.
- Essential oil which is usually a concentrated, hydrophobic liquid containing volatile aroma compounds from plants usually conveying characteristic fragrances.
- Non limiting examples include lavender, peppermint, and eucalyptus.
- a therapeutic oil is a hydrophobic liquid which is said to have a therapeutic effect or to have associated with it certain healing properties.
- Therapeutic oils contain active biologically occurring molecules and, upon topical application, exert a therapeutic effect.
- Non limiting examples include manuka oil, rosehip oil, which contains retinoids and is known to reduce acne and post-acne scars, and tea tree oil, which possesses antimicrobial activity including antibacterial, antifungal and antiviral properties as well as any other therapeutically beneficial oil known in the art of herbal medication.
- essential oils are considered “therapeutic oils.”
- Other non limiting examples of essential oils are basil, camphor, cardamom, carrot, citronella, clary sage, clove, cypress, frankincense, ginger, grapefruit, hyssop, jasmine, lavender, lemon, mandarin, marjoram, myrrh, neroli, nutmeg, petitgrain, sage, tangerine, vanilla and verbena.
- silicone oils include a cyclomethicone, dimethicone, a polyalkyl siloxane, a polyaryl siloxane, a polyalkylaryl siloxane, a polyether siloxane copolymer, a poly(dimethylsiloxane)-(diphenyl-siloxane) copolymer, a dimethyl polysiloxane, an epoxy-modified silicone oil, a fatty acid-modified silicone oil, a fluoro group-modified silicone oil, a methylphenylpolysiloxane, phenyl
- the silicone oil is cyclomethicone, cyclotetrasiloxane, cyclohexasiloxane, phyenyltrimethicone, Dow corning 246 Fluid (d6+d5) (cyclohexasiloxane & cyclopentasiloxane), Dow Corning 244 Fluid
- cyclotetrasiloxane Cyclomethicone 5-NF (cyclopentasiloxane), stearyl dimethicone, phenyltrimethicone, cetyl dimethicone, caprylyl methicone, PEG/PPG 18/18 dimethicone, or dimethiconol.
- the hydrophobic solvent may be selected from capric/caprylic triglycerides, cyclomethicone; isopropyl myristate, isopropyl palmitate, PPG-15 stearyl ether; octyldodecanol; isohexadecanol, diisopropyl adipate; cetearyl octanoate; ; MCT oil; heavy mineral oil; light mineral oil; coconut oil and soybean oil.
- the hydrophobic solvent is a mixture of one or more liquid hydrophobic solvents, as listed above, together with an additional hydrophobic substance, which is not liquid (such as petrolatum).
- an additional hydrophobic substance which is not liquid (such as petrolatum).
- the resultant mixture upon including propellant is liquid at ambient temperature.
- the main hydrophobic substance in the formulation is a petrolatum, which is a semi solid, in combination with at least one liquid hydrophobic solvent.
- petrolatum may be added to provide a degree of occlusivity so that the formulation when applied to a skin surface can operate to increase skin moisture and/or reduced transdermal water loss.
- a liquid hydrophobic solvent is not added. Fluidity of the composition can be achieved by utilizing liquidizing solvents (e.g.
- the hydrophobic solvent is a natural oil, extracted from plants, such as the fruit of olives or avocado or from their seeds, such as, grape seed oil or pomegranate seed oil.
- suitable oils which can also have a therapeutic effect, include almond oil, avocado oil, calendula oil, coconut oil, cocoglycerides, grape seed oil, jojoba oil, peanut oil, pomegranate seed oil, soy bean oil, and wheat germ oil.
- the hydrophobic solvent is a hydrocarbon based oil, such as light mineral oil or heavy mineral oil. Each oil has its own unique characteristics, as will be appreciated by a man of the art.
- oils Somewhere in between are soybean, wheat germ and coconut oils. Some oils have a strong natural odor, such as pomegranate seed oil whilst others display a milder odor, such as soybean, wheat germ, avocado, and almond. Others display a subtle or almost non existent odor, such as, jojoba, coconut, grape seed, calendula and peanut oil. Sometimes odor is a reflection of the level of processing the oil has undergone with a lower or disappearing odor reflecting a higher level of oil refinement. In an embodiment oils are blended to facilitate good absorption with unctuous occlusive properties. In one or more embodiments fragrance can be added to mask distinctive odors of oils. In one or more embodiments the oil is a mixture of two or more oils.
- the foamer complex comprises: a first member, comprising about 0.1% to about 20% by weight of a fatty alcohol; and a second member, comprising about 0.1 %> to about 20%> by weight of a fatty acid; and/or a wax.
- the amount of the first and second members respectively comprises about 0.4% to about 18% by weight.
- the amount of the first and second members each respectively comprises about 0.6% to about 12% by weight.
- the amount of the first and second members each respectively comprises about 0.8% to about 10% by weight.
- the amount of the first and second members each respectively comprises about 2% to about 7% by weight.
- each member respectively can be within any one of the following ranges (i) between about 0.1 % and about 1%, (ii) between about 1% and about 5%, (iii) between about 5% and about 10%, or (iv) between about 10% and about 20%. In one or more embodiments, each member is at a concentration at about 5% to about 10% by weight.
- the foamer complex includes a fatty alcohol.
- the fatty alcohol which acts as a foam adjuvant is included in the foamable compositions as a main constituent, to evolve the foaming property of the composition and/or to stabilize the foam.
- the fatty alcohol is selected from the group consisting of fatty alcohols having 15 or more carbons in their carbon chain, such as cetyl alcohol and stearyl alcohol (or mixtures thereof).
- fatty alcohols are arachidyl alcohol (C20), behenyl alcohol (C22), tetracosanol, hexacosanol, octacosanol, triacontanol, tetratriacontanol,l-triacontanol (C30), as well as alcohols with longer carbon chains (up to C50).
- the fatty alcohol has a carbon chain length of 14 to 22 carbons.
- the fatty alcohol is selected from the group consisting of fatty alcohols having 14 or less carbons in their carbon chain, such as lauryl alcohol and myristyl alcohol.
- the fatty alcohol is a solid at room temperature.
- the formulation is very viscous liquid fatty acids or fatty alcohols may for example be added, for example isostearic acid.
- the fatty alcohol is cetyl alcohol, stearyl alcohol, behenyl alcohol and combinations thereof.
- Fatty alcohols derived from beeswax and including a mixture of alcohols, a majority of which has at least 20 carbon atoms in their carbon chain, are suitable as fatty alcohols in the context herein.
- the amount of the fatty alcohol required to support the foam system can be approximately inversely related to the length of its carbon chains.
- the fatty alcohol is selected from the group consisting of fatty alcohols having 14 or less carbons in their carbon chain, such as myristyl alcohol. Fatty alcohols are also useful in facilitating improved spreadability and absorption of the composition.
- Fatty alcohols are amphiphatic, however unlike customary surfactants, they cannot usually function as stand-alone surfactants, because of their very weak emulsifying capacity. They are occasionally used as non-ionic co-emulsifiers, i.e., and are commonly used as thickeners (Surfactants in personal care products and decorative cosmetics By Linda D. Rhein, Mitchell Schlossman, Anthony O'Lenick, P., Third Edition, 2006, p. 247). Fatty alcohols are generally regarded as safe and they are not considered as irritants.
- fatty alcohols used in context of the composition disclosed herein are related to their therapeutic properties per se.
- Long chain saturated and mono unsaturated fatty alcohols e.g., stearyl alcohol, erucyl alcohol, arachidyl alcohol and behenyl alcohol (docosanol) have been reported to possess antiviral, antiinfective, antiproliferative and anti-inflammatory properties (see, U.S. Patent No. 4,874,794).
- Longer chain fatty alcohols e.g., tetracosanol, hexacosanol, heptacosanol, octacosanol, triacontanol, etc., are also known for their metabolism modifying properties and tissue energizing properties.
- the foamer complex further includes a fatty acid.
- the fatty acid which acts as a foam adjuvant is included in the foamable compositions to evolve the foaming property of the composition and/or to stabilize the foam.
- the fatty acid can have 16 or more carbons in its carbon chain, such as hexadecanoic acid (CI 6) heptadecanoic acid ,stearic acid (CI 8), arachidic acid (C20), behenic acid (C22), tetracosanoic acid (C24), hexacosanoic acid (C26), heptacosanoic acid (C27), octacosanoic acid (C28), triacontanoic acid, dotriacontanoic acid, tritriacontanoic acid, tetratriacontanoic acid and pentatriacontanoic acid, as well as fatty acids with longer carbon chains (up to C50), or mixture
- the carbon atom chain of the fatty acid may have at least one double bond; alternatively, the fatty acid can be a branched fatty acid.
- the carbon chain of the fatty acid also can be substituted with a hydroxyl group, such as 12-hydroxy stearic acid.
- the fatty acid is stearic acid.
- the oleaginous foamer complex may include a wax.
- the wax which acts as a foam adjuvant is included in the foamable compositions to evolve the foaming property of the composition and/or to stabilize the foam.
- Wax refers to beeswax or another substance with similar properties.
- the term wax refers to a class of substances with properties similar to beeswax, in respect of (i) plastic behavior at normal ambient temperatures, a melting point above approximately 45°C, (ii) a relatively low viscosity when melted (unlike many plastics); and (iii) hydrophobic nature.
- Paraffin wax is unique among other hydrocarbon chains by having a CST of about 25 (e.g., 25.5), which is about in the middle of the hydrophobic range.
- CST e.g. 25
- paraffin waxes are somewhat amphipatic which may also contribute to foam stability.
- paraffin wax is much more hydrophobic, thereby decreasing the surface tension of the hydrophobic solvents in the composition and facilitating foam formation and stabilization (the CST of polypropylene 31.0 and polyethylene 33.0).
- Hydrogenated castor oil consists mainly of triglycerides of hydroxystearic acid and is a solid wax.
- Beeswax contains a high proportion of wax esters (35 to 80%), which are linear monoesters of straight-chain fatty alcohols with even-numbered carbon chains from C24 to C36 esterified with straight-chain fatty acids such as 16:0 and 18:0 fatty acids some with hydroxyl groups in the ⁇ -2 and ⁇ -3 positions.
- the wax esters consist of C40 to C46 molecular species, Also present are free acids (about 14%) and carbohydrates (about 12%) as well as approximately 1% free wax alcohols and stearic esters of fatty acids.
- the wax is a polyolefm such as polyethylene, polypropylene, polymethylpentene , polybutene, a polyolefm elastomer, polyisobutylene , ethylene propylene rubber, ethylene propylene diene Monomer (M-class) rubber, polyethylene terephthalate, polydicyclopentadiene, linear polyolefms, branched polyolefms, cyclic polyolefins, low density polyolefins, high density polyolefins, polyolefins with a low molecular weight, polyolefins with a high molecular weight, halogenated polyolefins and the like and mixture thereof.
- a polyolefm such as polyethylene, polypropylene, polymethylpentene , polybutene, a polyolefm elastomer, polyisobutylene , ethylene propylene rubber, ethylene propylene dien
- the wax is polyvinyl chloride, polyvinylidene chloride, polyvinylidene fluoride, polyvinyl fluoride, polytetrafiuoro ethylene, polychlorotrifiuoro ethylene, polystyrene, polybutadiene, polyisoprene, polychloroprene, polymethylpentene and the like and mixture thereof.
- the wax is selected from the group consisting of beeswax, Chinese wax, lanolin wax, shellac wax, bayberry wax, candeliUa wax, carnauba wax, castor wax, esparto wax, japan wax, ouricury wax, rice bran wax, soy wax, a hydrogenated oil, hydrogenated castor oil, hydrogenated cottonseed oil, or hydrogenated jojoba oil, mink wax, montan wax, ozokerite, PEG-6 beeswax, rezo wax, spent grain wax, stearyl dimethicone, a paraffin wax, paraffin 58- 62°C wax , paraffin 51 -53°C wax, paraffin 42-44°C wax.
- the wax is selected from the waxes, as described in "The Complete Technology Book on Wax and Polishes, Publisher: Asia Pacific Business Press Inc., 2006" as incorporated herein by reference.
- the wax includes vegetable wax, bayberry wax, candeliUa wax, carnauba wax, flower wax, sandy wax, fat wax, cotton wax, esparto wax, fir wax, flax wax, Japan wax, ouricury wax, palm waxes, Cuban palm wax, rice-oil wax, sugar cane wax, ucuhuba wax, or cocoa butter.
- the wax includes synthetic mineral wax, fischer-tropsch wax, duroxon wax, or polymekon wax.
- Example 11 which looks at prior art formulations with a fatty alcohol, alone, a foam of good quality is not obtained.
- a fatty alcohol or a mixture of fatty alcohols
- a fatty acid or a mixture of fatty acids
- a wax or a mixture of waxes
- the foamer complex is a synergistic combination of a fatty alcohol (or a mixture of fatty alcohols) and a fatty acid (or a mixture of fatty acids).
- the foamer complex is a synergistic combination of a fatty alcohol (or a mixture of fatty alcohols) and a wax (or a mixture of waxes).
- the foamer complex is a synergistic combination of a fatty alcohol (or a mixture of fatty alcohols), a fatty acid (or a mixture of fatty acids) and a wax (or a mixture of waxes).
- the range of ratio of fatty alcohol to fatty acid/wax can be about 100: 1 to about 1 : 100; or about 90:1 to about 1 :45; or about 80: 1 to about 1 :40; or about 70: 1 to about 1 :35; or about 60: 1 to about 1 :30; or about 50:1 to about 1 :25; or about 40: 1 to about 1 :20; or about 30: 1 to about 1 : 15; or about 20: 1 to about 1 : 10; or about 15: 1 to about 1 :5; or about 10: 1 to about 1 : 1 ; or any ranges in between such as 1 :20 to 20 : 1 , or preferably from 1 : 10 to 10: 1, or 1 :4 to 4: 1, or 2:3 or 3:2.
- the foamer complex can be a fatty alcohol and shea butter, a fatty acid and shea butter or a combination of a fatty alcohol and a fatty acid and shea butter.
- Shea butter may, for example, be used instead of paraffin wax or instead of bees wax or instead of hydrogenated caster oil or to complement one or more of them.
- wax and/or shea butter comprising complexes can be effective with petrolatum based compositions.
- oily emollients are added to provide or improve a pleasant skin feeling, and/or lubricating effect with reduced friction.
- volatile silicones are added to reduce greasy feeling.
- various waxes are added to improve rheology or stabilize foam structure.
- composition requires the addition of a propellant in order to generate a foam.
- Suitable propellants include volatile hydrocarbons such as butane, propane, isobutene or mixtures thereof.
- a hydrocarbon mixture AP-70 is used.
- a lower pressure hydrocarbon mixture AP-46 is used. Both contain butane, propane, isobutene although in different proportions.
- AP-70 is composed of about 50% w/w of propane, about 20% w/w of isobutane and about 30%> w/w of propane.
- AP-46 is composed of about 16%> w/w of propane, about 82% w/w of isobutane and about 2% w/w of propane.
- Hydrofluorocarbon (HFC) propellants are also suitable as propellants in the context disclosed herein.
- exemplary HFC propellants include 1,1,1,2 tetrafluorethane (Dymel 134), and 1,1,1,2,3,3,3 heptafluoropropane (Dymel 227).
- Dimethyl ether is also useful.
- compressed gases e.g., air, carbon dioxide, nitrous oxide, and nitrogen
- composition In preparing the formulations the ingredients other than propellant are combined to 100% and the propellant is added thereafter so that the ratio of formulation to propellant can range from 100: 1 to 100:30; 100:3 to 100:30; 100:4 to 100:25 or preferably or preferably 100:5 to 100: 16. Yet, in additional embodiments, the ratio of composition other than propellant to propellant is between about 100:20 and about 100:50.
- foams Another property of the foam is specific gravity or density, as measured upon release from the aerosol can.
- foams typically have specific gravity of less than 0.50 g/mL or less than 0.12 g/mL, depending on their composition and on the propellant concentration. In one or more embodiments the foam density is about less than 0.3g/mL.
- the collapse time of foam represents its tendency to be temperature-sensitive and its ability to be at least stable in the short term so as to allow a user sufficient time to comfortably handle and apply the foam to a target area without being rushed and/or concerned that it may rapidly collapse, liquefy and/or disappear.
- Collapse time as an indicator of thermal sensitivity, is examined by dispensing a given quantity of foam and photographing sequentially its appearance with time during incubation at 36°C.
- Simple collapse time can be measured by applying a foam sample on a body surface like the fingers at normal body temperature of about 37 °C (Collapse time is further described in the Examples).
- Such particles can have various functions, such as (1) protection of the drug from degradation; (2) modification of the drug release rate from the composition; (3) control of skin penetration profile; and (4) mitigation of adverse effects, due to the controlled release of the active agent from the encapsulation particles.
- the active agent is “soluble”, “freely soluble” or “very soluble” (as defined above) in the composition. Yet, in certain cases, the active agent is “very slightly soluble”, “slightly soluble” or “sparingly soluble” in the composition.
- the active agent is insoluble i.e., "requires 10,000 parts or more of a solvent to be solubilized", in the composition.
- the active agent is micronized, which can assist in delivery into the skin, mucosal membrane and body cavity surfaces and also aid homogenous distribution within the formulation.
- part of the active agent is presented to a target in soluble form and part is presented in insoluble form.
- insoluble agent is suspended.
- the suspension is homogenous.
- the formulation is readily re-suspended and homogenous on shaking.
- the agent is soluble.
- the active agent is used to prevent a disease or disorder. In one or more embodiments the active agent is used to treat or alleviate a disease or disorder. In one or more embodiments the active agent is used to protect a target.
- An example of protection includes protection from radiation or the effects thereof.
- an antibiotic agent is a substance, that has the capacity to inhibit the growth of or to destroy bacteria and other microorganisms.
- the antibiotic agent is selected from the classes consisting beta-lactam antibiotics, aminoglycosides, ansa-type antibiotics, anthraquinones, antibiotic azoles, antibiotic glycopeptides, macrolides, antibiotic nucleosides, antibiotic peptides, antibiotic polyenes, antibiotic polyethers, quinolones, antibiotic steroides, sulfonamides, tetracycline, dicarboxylic acids, antibiotic metals including antibiotic metal ions, oxidizing agents, a periodate, a hypochlorite, a permanganate, substances that release free radicals and/or active oxygen, cationic antimicrobial agents, quaternary ammonium compounds, biguanides, triguanides, bisbiguanides and analogs and polymers thereof, naturally occurring antibiotic compounds, including antibiotic plant oils and antibiotic plant extracts and any one of the following antibiotic compounds including non classified antibiotic compound analogs, derivatives, salts, ions, complexes and mixtures
- the antibiotic agent is a tetracycline.
- the tetracyclines (also referred to herein as "tetracycline antibiotics") are a group of antibacterials, originally derived from certain Streptomyces spp., having the same tetracyclic nucleus, naphthacene, and similar properties. They are usually bacteriostatic but act by interfering with protein synthesis in susceptible organisms. Tetracycline antibiotics are susceptible to degradation by oxidation.
- Tetracyclines include, but are not limited to, dihydrosteffimycin,
- Chlortetracycline, oxytetracycline, tetracycline, demeclocycline are all natural products that have been isolated from Streptomyces spp.
- the more recent tetracyclines, namely methacycline, doxycycline, and minocycline, are semisynthetic derivatives.
- Methacycline, like demeclocycline, has a longer half-life than tetracycline.
- Minocycline is active against some tetracycline-resistant bacteria, including strains of staphylococci. Both doxycycline and minocycline are more lipid-soluble than the other tetracyclines and they penetrate well into tissues.
- tetracyclines have also been useful in the treatment of penicillin-allergic patients suffering from venereal diseases, actinomycosis, bronchitis, and leptospirosis. Minocycline may sometimes be used in multidrug regimens for leprosy.
- Doxycycline may be used for the treatment and prophylaxis of malaria; it is also used in the management of anthrax.
- Tetracycline antibiotics can be incorporated into the formulations of the present invention to treat, ameliorate or prevent a multitude of disorders responsive to tetracycline antibiotics.
- the formulations can be applied topically to the skin or to the genitals or to mucosal membranes and on and around the eye, sub-gingival and can be applied into a wide range of body cavities, including aural, digestive, oral, nasal, urethra, penal, endocervical, rectum, respiratory, and vaginal and tooth pocket.
- Non limiting examples of applications include eye infections, blepharitis, dry eye, inclusion conjunctivitis, glaucoma, inflammatory ocular conditions where bacterial infection or a risk of bacterial ocular infection exists, neuropathic atrophy (in diabetes), abrasions, injuries, wounds, burns, ulcers, pyoderma, furunculosis, granuloma inguinale, periodontitis, rosacea , post-operation infections and tissue reconstruction, trachoma,
- the active pharmaceutical tetracycline can be present by weight in the range of about 0.2% to about 20%, or at about 0.2%, at about 0.3%>, at about 0.4%>, at about 0.5%>, at about 0.6%>, at about 0.7%>, at about 0.8%>, at about 0.9%), at about 1%, at about 1.5%, at about 2%, at about 2.5%, at about 3%, at about 3.5% at about 4%, at about 4.5%, at about 5%, at about 6%,at about 7%, at about 8%, at about 9%, at about 10%, at about 12%, or at about 14%, at about 16%, at about 18%, or at about 20%.
- Tetracyclines have been used in ophthalmic ointments for the prevention or treatment of infections of the eye caused by susceptible bacteria. Although minor skin infections and wounds usually heal without treatment, some minor skin wounds do not heal without therapy and it is impossible to determine at the time of injury which wounds will be self-healing. Therefore, some experts believe that, by reducing the number of superficial bacteria, topical anti-infectives are useful for preventing infection in minor skin injuries (e.g., cuts, scrapes, burns).
- Tetracycline hydrochloride may be used topically in the treatment of inflammatory acne vulgaris. Tetracyclines are usually bacteriostatic in action, but may be bactericidal in high concentrations or against highly susceptible organisms.
- the reduction in free fatty acids in sebum may be an indirect result of the inhibition of lipase-producing organisms which convert triglycerides into free fatty acids or may be a direct result of interference with lipase production in these organisms.
- Free fatty acids are comedogenic and are believed to be a possible cause of the inflammatory lesions (e.g., papules, pustules, nodules, cysts) of acne.
- other mechanisms also appear to be involved because clinical improvement of acne vulgaris with topical tetracyclines does not necessarily correspond with a reduction in the bacterial flora of the skin or a decrease in the free fatty acid content of sebum. (Martindale Electronic Version 2007).
- the tetracycline is doxycycline.
- Doxycycline is a tetracycline antibiotic and also has anti-inflammatory and immunomodulatory effects.
- Doxycycline is a semisynthetic tetracycline antibiotic derived from oxytetracycline. In addition to antimicrobial activity, the drug has anti-inflammatory and immunomodulatory effects. It is available as Doxycycline calcium, doxycycline hyclate and doxycycline monohydrate.
- Doxycycline hyclate and doxycycline monohydrate occur as yellow, crystalline powders.
- the hyclate is soluble in water and slightly soluble in alcohol; the monohydrate is very slightly soluble in water and sparingly soluble in alcohol.
- Doxycycline calcium is formed in situ during the manufacturing process. Following reconstitution of doxycycline hyclate powder for IV administration with sterile water for injection, solutions have a pH of 1.8-3.3.
- Doxycycline is used for the treatment of rosacea treatment or prophylaxis of anthrax (including inhalational anthrax [postexposure]), treatment of presumed or confirmed rickettsial infections, including Rocky Mountain spotted fever (RMSF), fever, ehrlichiosis, and
- anaplasmosis and for the treatment of Bartonella infections, for the treatment of brucellosis, for the treatment of Burkholderia Infections, Chlamydial Infections , Lymphogranuloma venereum Psittacosis, Ehrlichiosis and Anaplasmosis, Gonorrhea and Associated Infections, Epididymitis, Proctitis, Granuloma Inguinale (Donovanosis,) Legionella Infections, Leptospirosis, Lyme Disease, Prophylaxis of Lyme Disease, Erythema Migrans, Early Neurologic Lyme Disease, Lyme Carditis, or Borrelial Lymphocytoma, Lyme Arthritis, Malaria, and prevention,
- doxycycline hyclate IV solutions containing 0.1-1 mg of doxycycline per mL are stable for 48 hours at 25°C; when reconstituted and diluted with Ringer's, 10% invert sugar, Normosol-M ® in D5W, Normosol-R ® in D5W, Plasma-Lyte ® 56 in 5% dextrose, or Plasma-Lyte ® 148 in 5% dextrose, doxycycline hyclate IV solutions containing 0.1-1 mg/mL are stable for 12 hours at room temperature.
- Preparations of doxycycline hyclate have an acid pH and incompatibility may reasonably be expected with alkaline preparations or with drugs unstable at low pH.
- Doxycycline is more active than tetracycline against many bacterial species including Streptococcus pyogenes, enterococci, Nocardia spp., and various anaerobes. Cross-resistance is common although some tetracycline-resistant Staphylococcus aureus respond to doxycycline. Doxy eye line is also more active against protozoa, particularly Plasmodium spp.
- the tetracycline is minocycline.
- Minocycline hydrochloride is a semisynthetic tetracycline antibiotic derived from tetracycline. The drug is usually bacteriostatic in action; it exerts its antimicrobial activity by inhibiting protein synthesis. It is a yellow crystalline powder that is sparingly soluble in water; slightly soluble in alcohol; practically insoluble in chloroform and in ether; soluble in solutions of alkali hydroxides and carbonates. pH of a solution in water containing the equivalent of minocycline 1% is between 3.5 and 4.5. Preparations of minocycline hydrochloride have an acid pH and incompatibility may reasonably be expected with alkaline preparations or with drugs unstable at low pH.
- Minocycle is highly sensitive and should be stored in airtight containers and protected from light to prevent degradation. Therefore use in foamable formulations stored in airtight sealed containers under pressure with propellant may contribute to preserving stability subject to selection of compatible canisters and accessories.
- hydrophobic emollients and waxes revealed compatibility with Minocyline, except for pomegranate seed oil.
- Minocycline was delivered intradermally at sufficient levels to treat skin infections but did not pass through the skin transdermally and therefore topical application should be free from adverse systemic effects.
- UVB irradiation of the skin is known to decrease cell viability, total antioxidant capacity, while increasing the levels of inflammation (pro-inflammatory cytokines secretion) and epidermal cell apoptosis.
- Photosensitivity manifested as an exaggerated sunburn reaction on areas of the body exposed to direct sunlight or ultraviolet light, has occurred with tetracyclines and Minocycline has been associated with pigmentation of the skin and other tissues.
- oleaginous formulations containing Minocycline had not only protective properties as known in the art but also therapeutic properties in the case of UVB-induced skin damage.
- Cell viability was increased and apoptosis was decreased in a dose-dependant manner when formulation was applied pre UVB irradiation.
- Apoptosis activation was significantly decreased when the formulation was applied post UVB irradiation of a skin organ culture.
- it may be able to reduce skin photodamage and photoaging, and more generally to reduce oxidative stress and inflammation in skin pathologies which are known to be accompanied by apoptotic cell death for example rosacea and impetigo.
- the increase in viability of cells indicates that Minocycline has regenerative properties.
- these properties and uses of minocycline may extend to other tetracycline antibiotics.
- the substantially surfactant- free oleaginous formulations comprising a tetracycline such as, Minocycline have protective and therapeutic properties in the case of UVB-induced skin damage.
- the substantially surfactant-free oleaginous formulations comprising a tetracycline such as,
- Minocycline have properties selected from a list including anti-apoptotic, anti-inflammatory, anti-photodamaging and anti-photoaging.
- the substantially surfactant-free oleaginous formulations comprising a tetracycline, such as,
- Minocycline have activity that decreases apoptosis and increases cell viability.
- substantially surfactant- free oleaginous formulations comprising a tetracycline, such as, Minocycline for use to reduce oxidative stress and
- Minocycline has a spectrum of activity and mode of action similar to that of tetracycline but it is more active against many species including Staphylococcus aureus, streptococci, Neisseria meningitidis, various enterobacteria, Acinetobacter, Bacteroides,
- Minocycline also inhibited the growth of Streptococcus pyogenes, Pseudomonas aeruginosa, Staphylococcus aureus, as well as a methicillin-resistant strain of Staphylococcus aureus (MRS A) and Propionbacterium acnes.
- Minocycline is a tetracycline derivative with uses similar to those of tetracycline. It is also a component of multidrug regimens for the treatment of leprosy and has been used in the prophylaxis of meningococcal infection to eliminate the carrier state, but the high incidence of vestibular disturbances means that it is not the drug of choice for the latter. It has neuroprotective properties. It is being investigated for motor neurone disease, for the management of Huntington's chorea. It is used in the treatment of rheumatoid arthritis and in the treatment of various skin disorders, including acne.
- the active agent is a steroid.
- the steroid is a corticosteroid, including but not limited to, hydrocortisone, hydroxyltriamcinolone, alpha- methyl dexamethasone, dexamethasone -phosphate, beclomethsone dipropionate, clobetasol valemate, desonide, desoxymethasone, desoxycorticosterone acetate, dexamethasone,
- dichlorisone diflorasone diacetate, diflucortolone valerate, fluadrenolone, fluclorolone acetonide, fludrocortisone, flumethasone pivalate, fluosinolone acetonide, fluocinonide, flucortine butylester, fluocortolone, fluprednidene (fluprednylidene) acetate, flurandrenolone, halcinonide, hydrocortisone acetate, hydrocortisone butyrate, methylprednisolone, triamcinolone acetonide, cortisone, cortodoxone, flucetonide, fludrocortisone, difluorosone diacetate, fluradrenolone acetonide, medrysone, amcinafel, amcinafide, betamethasone and the balance of its esters, chloroprednisone, chlorprednisone acetate,
- difluprednate difluprednate, flucloronide, flunisolide, fluoromethalone, fluperolone, fluprednisolone, hydrocortisone valerate, hydrocortisone cyclopentylpropionate, hydrocortmate, mepreddisone, paramethasone, prednisolone, prednisone, beclomethasone dipropionate, triamcinolone, as well as analogs, derivatives, salts, ions and complexes thereof.
- the active pharmaceutical agent is delivered by more than one route, for example, topically and body cavity.
- the steroid is mometasone furoate. In certain embodiments it can be used topically to treat psoriasis and dermatitis. In certain other embodiments it can be applied in nasal administration to treat disorders, such as, allergic rhinitis and asthma.
- the active agent is a non-steroidal anti-inflammatory agent.
- NSAID nonsteroidal antiinflammatory agent
- pharmaceutically active compound other than a corticosteroid, which affects the immune system in a fashion that results in a reduction, inhibition, prevention, amelioration or prevention of an inflammatory process and/or the symptoms of inflammation and/or the production proinflammatory cytokines and other pro-inflammatory mediators, thereby treating or preventing a disease that involves inflammation.
- the NSAID is an inhibitor of the cyclooxygenase (COX) enzyme.
- COX cyclooxygenase
- COX- 1 the constitutive cyclooxygenase
- COX-2 the inducible cyclooxygenase
- the NSAID is selected from the group consisting of a COX-1 inhibitor, a COX-2 inhibitor or a non-selective NSAID, which simultaneously inhibits both COX-1 and COX-2.
- the NSAID is salicylic acid a salicylic acid derivatives.
- exemplary salicylic acid derivative include, in a non limiting fashion, aspirin, sodium salicylate, choline magnesium trislicylate, salsalate, diflunisal, salicylsalicylic acid, sulfasalazine, olsalazine, esters of salicylic acid with a carboxylic acid, esters of salicylic acid with a dicarboxylic acid, esters of salicylic acid with a fatty acid, esters of salicylic acid with a hydroxyl fatty acid, esters of salicylic acid with an essential fatty acid, esters of salicylic acid with a polycarboxylic acid, and any compound wherein salicylic acid is linked to an organic moiety through a covalent bond.
- the NSAID is para-aminophenol (e.g., acetaminophen) and salts and derivatives thereof.
- the NSAID is an indole or an indole - acetic acid derivative (e.g., indomethacin, sulindac, etodolac) and salts and derivatives thereof.
- an indole or an indole - acetic acid derivative e.g., indomethacin, sulindac, etodolac
- the NSAID is an aryl acetic acids (e.g., tolmetin, diclofenac, ketorolac) and salts and derivatives thereof.
- aryl acetic acids e.g., tolmetin, diclofenac, ketorolac
- the NSAID is an arylpropionic acid and salts and derivatives thereof.
- exemplary arylpropionic acid derivative include, in a non limiting fashion, are ibuprofen, naproxen, flubiprofen, ketoprofen, fenoprofen, oxaprozin.
- the NSAID is anthranilic acids or an anthranilic acid derivative, also termed “fenamates” (e.g., mefenamic acid, meclofenamic acid) and salts and derivatives thereof.
- fenamates e.g., mefenamic acid, meclofenamic acid
- the NSAID is selected from the group of enolic acids, enolic acid salts, enolic acid esters, amides, anhydrides and salts and derivatives thereof.
- enolic acid derivatives include oxicams (piroxicam, tenoxicam) and pyrazolidinediones (phenylbutazone, oxyphenthratrazone)
- Selective COX-2 Inhibitors include, in an exemplary manner diaryl-substituted furanones (e.g., Rofecoxib); diaryl-substituted pyrazoles (e.g., Celecoxib); indole acetic acids (e.g., Etodolac); and sulfonanilides (e.g., Nimesulide) and salts and derivatives thereof.
- diaryl-substituted furanones e.g., Rofecoxib
- diaryl-substituted pyrazoles e.g., Celecoxib
- indole acetic acids e.g., Etodolac
- sulfonanilides e.g., Nimesulide
- the active agent is a local anesthetic agent.
- the anesthetic agent can be selected from the group consisting of benzocaine, lidocaine, bupivacaine, chlorprocaine, dibucaine, etidocaine, mepivacaine, tetracaine, dyclonine, hexylcaine, procaine, cocaine, ketamine, pramoxine, phenol, any pharmaceutically acceptable salts thereof and mixtures of such anesthetic agents. Any mixture of synergistically beneficial anesthetic agents is contemplated.
- a keratolytic agent may be included as an active agent of a foamable composition.
- the term "keratolytically active agent” as used herein includes a compound that loosens and removes the stratum corneum of the skin, or alters the structure of the keratin layers of skin. Keratolytically active agents are used in the treatment of dermatological disorders that involve dry skin, hyperkeratinization (such as psoriasis), skin itching (such as xerosis), acne and rosacea.
- Suitable keratolytically active agents include phenol and substituted phenolic compounds. Such compounds are known to dissolve and loosen the intracellular matrix of the hyperkeratinized tissue. As such, they are used in the treatment of dermatological disorders. Dihydroxybenzene and derivatives thereof have been recognized as potent keratolytic agents. Resorcinol (m-dihydroxybenzene) and derivatives thereof are used in anti-acne preparations. In addition to hydroquinone (p-dihydroxybenzene) having anti-pigmentation properties, hydroquinone is also known to be keratolytic. These compounds also exhibit antiseptic properties. Cresols also possess bactericidal and keratolytic properties.
- Vitamin A and vitamin A derivatives also termed herein “retinoids”, such as retinoic acid, isoretinoic acid, retinol and retinal, as well as adapalene, tazarotene, isotretinoin, acitretin and additional retinoids known in the art of pharmaceuticals and cosmetics are another class of keratolytically active agents.
- retinoids such as retinoic acid, isoretinoic acid, retinol and retinal
- Another class of keratolytically active agents includes urea and urea derivatives.
- the active agent is an immunomodulator.
- Immunomodulators are chemically or biologically-derived agents that modify the immune response or the functioning of the immune system.
- Immunomodulators suitable for use according to the present invention include, among other options, cyclic peptides, such as cyclosporine, tacrolimus, tresperimus, pimecrolimus, sirolimus, verolimus, laflunimus, laquinimod and imiquimod, as well as analogs, derivatives, salts, ions and complexes thereof.
- Such compounds, delivered in the foam are especially advantageous in skin disorders such as psoriasis, eczema and atopic dermatitis, where the large skin areas are to be treated.
- the active agent is a retinoid.
- Retinoids suitable for use according to the present invention include, among other options, retinol, retinal, retinoic acid, isotretinoin, tazarotene, adapalene, 13-cis-retinoic acid, acitretin all-trans beta carotene, alpha carotene, lycopene, 9-cis-beta-carotene, lutein and zeaxanthin, as well as any additional retinoids known in the art of pharmaceuticals and cosmetics; and analogs, derivatives, salts, ions and complexes thereof.
- the active agent is an anti-acne or an anti-rosacea agent.
- the antiacne agent can be selected from the group consisting of resorcinol, sulfur, salicylic acid and salicylates, alpha-hydroxy acids, nonsteroidal anti-inflammatory agents, benzoyl peroxide, retinoic acid, isoretinoic acid and other retinoid compounds, adapalene, tazarotene, azelaic acid and azelaic acid derivatives, antibiotic agents, such as minocycline erythromycin and
- the active agent is an anti-infective agent.
- anti-infective agent can be selected from the group of an antibiotic agent, an antibacterial agent, an antifungal agent, an agent that controls yeast, an antiviral agent and an antiparasitic agent.
- the foamable composition essential ingredients as active agents
- hydrophobic solvent possesses therapeutic properties on its own and therefore, it can be regarded as "active agent.”
- active agent some essential oils kill microorganisms and can be effective in the treatment or prevention of conditions that involve microbial infection, such as bacterial, fungal and viral conditions.
- the occlusive effect of hydrophobic solvents is useful for the treatment of conditions which involve damaged skin, such as psoriasis or atopic dermatitis.
- the combination of a hydrophobic solvent and a therapeutically effective fatty alcohol or fatty acid may afford a synergistic beneficial effect in conditions characterized, for example, by infection and/or inflammation.
- psoriasis involves excessive cell proliferation and inadequate cell differentiation as well as inflammation.
- Atopic dermatitis involves keratinocyte growth abnormality, skin dryness and inflammation.
- Bacterial, fungal and viral infections involve pathogen colonization at the affected site and inflammation.
- the foamable composition can be desirable.
- the foamable composition further includes at least two active agents, in a therapeutically effective concentration.
- one of the active agents is a vitamin, a vitamin derivative or analogue thereof.
- the vitamin, vitamin derivative or analogue thereof is oil soluble.
- Microsponges are rigid, porous and spongelike round microscopic particles of cross-linked polymer beads (e.g., polystyrene or copolymers thereof), each defining a substantially noncoUapsible pore network.
- Microsponges can be loaded with an active ingredient and can provide a controlled time release of the active ingredient to skin or to a mucosal membrane upon application of the formulation. The slow release is intended to reduce irritation by the active agent.
- Microsponge® delivery technology was developed by Advanced Polymer Systems.
- the composition comprises one or more active agents loaded into Microponges with a waterless carrier described herein, which may also comprise a modulating agent.
- foamable carrier of the present disclosure is suitable for treating any inflicted surface.
- foamable carrier is suitable for administration to the skin, a body surface, a body cavity or mucosal surface, e.g., the cavity and/or the mucosa of the nose, mouth, eye, respiratory system, vagina, urethra or rectum and the ear canal (severally and interchangeably termed herein "target site").
- the foamable carrier of the present disclosure is also suitable for preventing a disorder or disease prior to its onset.
- the foamable carrier comprising for example a tetracycline may be applied to a body surface or a body cavity to try and prevent apoptosis, a disorder or disease prior to onset thereof.
- a medical procedure requiring intervention such as chemo therapy; radiotherapy, photodynamic therapy, laser therapy, etc.
- a tetracycline antibiotic might be used to prevent a disease or disorder, which includes prophylaxis of gonococcal and chlamydial ophthalmia, neonatal conjunctivitis, periodontal disease, postoperative tetracycline , prophylaxis in pregnancy termination, for prevention of skin rash/acneiform skin eruption during cancer therapy, intraoperative topical tetracycline sclerotherapy following mastectomy for prevention of postoperative mastectomy seromas etc.
- the foamable composition of the present disclosure is useful in preventing or treating an animal or a human patient having any one of a variety of dermatological or mucosal diseases or disorders; in alleviating such diseases or disorders; or where such agent or agents have shown proficiency in preventative therapy in preventing such diseases or disorders , including but not limited to a bacterial infection, a benign tumor, a bullous disease, a burn, a chlamydia infection, a condition which respond to hormone therapy, a cut, a dermatitis, a dermatophyte infection, a dermatose, a disorder of a body cavity, a disorder of cornification, a disorder of the nose, a disorder of the penile urethra or ear canal, a disorder of the rectum, a disorder of the respiratory system, a disorder of the vagina, a disorder which responds to hormone replacement therapy, a disorder which responds to transdermal
- gynecological disorders that respond to hormonal therapy, a malignant tumor, a non- dermatological disorder which responds to topical or transdermal delivery of an active agent, a parasitic infection, a pelvic inflammation, a pigmentation disorder, a scaling papular diseases, a sexual dysfunction disorder, a sexually transmitted disease, a vaginal disorder, a viral infection, a vulvar disorder, a vulvovaginal infection, a wound, a yeast infection, abscess, acne, acne conglobata, acne fulminans, acne scars, acne vulgaris, actinic keratosis, acute and chronic salpingitis, acute febrile neutrophilic dermatosis, acute lymphangitis, acute pelvic inflammatory disease, acute soft tissue injury, albinism, allergic contact dermatitis, alopecia, alopecia areata, alopecia totalis, alopecia universalis, an allergy, an anal abscess or fistula, an anal and rec
- the foamable composition of the present disclosure is suitable for preventing or treating a disorder of a body cavity or mucosal surface, e.g., the mucosa of the nose, mouth, eye, ear, respiratory system, vagina, urethra, or rectum.
- a disorder of a body cavity or mucosal surface e.g., the mucosa of the nose, mouth, eye, ear, respiratory system, vagina, urethra, or rectum.
- Non limiting examples of such conditions include chlamydia infection, gonorrhea infection, hepatitis B, herpes, HIV/ AIDS, human papillomavirus (HPV), genital warts, bacterial vaginosis, candidiasis, chancroid, granuloma Inguinale, lymphogranloma venereum, mucopurulent cervicitis (MPC), molluscum contagiosum, nongonococcal urethritis (NGU), trichomoniasis, vulvar disorders, vulvodynia, vulvar pain, yeast infection, vulvar dystrophy, vulvar intraepithelial neoplasia (VIN), contact dermatitis, pelvic inflammation, endometritis, salpingitis, oophoritis, genital cancer, cancer of the cervix, cancer of the vulva, cancer of the vagina, vaginal dryness, dyspare
- the composition is useful for the treatment of an infection.
- the composition is suitable for the treatment of an infection, selected from the group of a bacterial infection, a fungal infection, a yeast infection, a viral infection and a parasitic infection.
- the composition is useful for the treatment of wound, ulcer and burn. This use is particularly important since the composition of the present disclosure creates a thin, semi-occlusive layer, which coats the damaged tissue, while allowing exudates to be released from the tissue.
- composition of the present disclosure is also suitable for administering a hormone to the skin or to a mucosal membrane or to a body cavity, in order to deliver the hormone into the tissue of the target organ, in any disorder that responds to treatment with a hormone.
- the disorder is an inflammation, skin inflammation, acne, rosacea, actinic keratosis, skin cancer, a local pain, joint pain and osteoarthritis;
- the active agent is a nonsteroidal anti-inflammatory drug, given at a therapeutically effective concentration.
- the composition In light of the hygroscopic nature of the composition, it is further suitable for the treatment and prevention of post-surgical adhesions. Adhesions are scars that form abnormal connections between tissue surfaces. Post-surgical adhesion formation is a natural consequence of surgery, resulting when tissue repairs itself following incision, cauterization, suturing, or other means of trauma.
- the foam When comprising appropriate protective agents, the foam is suitable for the treatment or prevention of post surgical adhesions.
- the use of foam is particularly advantageous because foam can expand in the body cavity and penetrate into hidden areas that cannot be reached by any other alternative means of administration.
- the composition may be used for cosmetic use.
- it may be used as part of a cosmetic formulation to prevent a cosmetic disorder or to improve the skin.
- it may be used with cosmetic effect for example as a cosmetic remover. It can be dispensed in small quantities as a foam targeted to a surface and applied locally with mechanical force causing the foam to break.
- Topical administration is any form of administration that reaches a body organ topically, such as epicutaneous administration (application onto the skin), inhalation, enema, eye drops (onto the conjunctiva), ear drops, intranasal (into the nose) and vaginal.
- Ophthalmic dosage forms include eye drop (solution or suspension), ophthalmic gel and ophthalmic ointment.
- the dosage form is a foam that is thermally stable and breakable under shear force but is not "quick breaking" which allows comfortable application and well directed administration to the target area.
- Enteral is any form of administration that involves any part of the gastrointestinal tract by mouth (orally), as buccal or sublingual tablets, capsules, suspensions, solutions, powder or drops; by gastric feeding tube, duodenal feeding tube, or gastrostomy; and rectally, in suppository or enema form.
- Intravenous into a vein
- intraarterial into an artery
- intramuscular into a muscle
- intracardiac into the heart
- subcutaneous under the skin
- intraosseous infusion into the bone marrow
- intradermal into the skin itself
- intrathecal into the spinal canal
- intraperitoneal into the peritoneum
- Step 1 Hydrophobic solvents such as mineral oils are mixed at room temperature. Others solvents such as silicones, if present, are added at room temperature under mixing until formulation homogeneity is obtained.
- Step 3 The formulation is cooled down to 30-40°C and active agents if present, and water if present are added under mixing until formulation homogeneity is obtained.
- Each aerosol canister is filled with the pre- foam formulation ("PFF", i.e., foamable carrier) and crimped with valve using vacuum crimping machine.
- PFF pre- foam formulation
- the process of applying a vacuum will cause most of the oxygen present to be eliminated.
- Addition of hydrocarbon propellant may, without being bound by any theory, further help to reduce the likelihood of any remaining oxygen reacting with the active ingredient.
- Pressurizing is carried out using a hydrocarbon gas or gas mixture. Canisters are filled and then warmed for 30 seconds in a warm bath at 50°C and well shaken immediately thereafter.
- Collapse Time which is the measure of thermal stability, is examined by dispensing a given quantity of foam and photographing sequentially its appearance with time during incubation at 36°C.
- the collapse time result is defined as the time when the foam height reaches 50% of its initial height or if the foam has not yet reached 50% of its initial height after say 180 seconds then the collapse time is recorded as being >180.
- one foam may remain at 100% of its initial height for three minutes, a second foam may reach 90% of its initial height after three minutes, a third foam may reach 70% of its initial height after three minutes, and a fourth foam may reach 51% of its initial height after three minutes, nevertheless in each of these four cases the collapse time is recorded as >180 seconds since for practical purposes for easy application by a patient to a target the majority of the foam remains intact for more than 180 seconds. If the foam for example reaches 50% of its original height after say 100 seconds it would be recorded as having a collapse time of 100 seconds. It is useful for evaluating foam products, which maintain structural stability at skin temperature for at least 1 minute. Foams which are structurally stable on the skin for at least one minute are termed "short term stable" carriers or foams.
- the foam product is dispensed into vessels (including dishes or tubes) of a known volume and weight. Replicate measurements of the mass of foam filling the vessels are made and the density is calculated.
- the canister and contents are allowed to reach room temperature. Shake the canister to mix the contents and dispense and discard 5-10 mL. Then dispense foam into a pre-weighed tube, filling it until excess is extruded. Immediately remove (level off) excess foam at both ends and weigh the filled tube on the weighing balance. Viscosity
- Foam appearance under extreme conditions of repeated heating and cooling is evaluated by cycling through cooling, heating, (first cycle) cooling, heating (second cycle) etc., conditions, commencing with -10°C (24 hours) followed by +40°C (24 hours) and measuring the appearance following each cycle. The cycle is repeated for up to three times.
- Foams are made of gas bubbles entrapped in liquid.
- the bubble size and distribution reflects in the visual texture and smoothness of the foam.
- Foam bubbles size is determined by dispensing a foam sample on a glass slide, taking a picture of the foam surface with a digital camera equipped with a macro lens. The diameter of about 30 bubbles is measured manually relatively to calibration standard template. Statistical parameters such as mean bubble diameter, standard deviation and quartiles are then determined. Measuring diameter may also be
- the camera used was a Nikon D40X Camera
- the centrifugation used in this procedure serves as a stress condition simulating the aging of the liquid formulation under investigation. Under these conditions, the centrifugal force applied facilitates coalescence of dispersed globules or sedimentation of dispersed solids, resulting in loss of the desired properties of the formulation.
- the centrifuge can be a BHG HEMLE Z 231 M.
- the receiving compartments were sampled at baseline and 3, 6, 9 and 24 hours following application. At the 24 hours time point the skin was processed as follows:
- Sequential 19 tapes (9 and 10) were transferred into two separate vials with 3 mL extraction solution ("Stratum Corneum 1" and "Stratum Corneum 2").
- the circular skin area (1.77 cm2) was cut and transferred to a 3 mL extraction solution (Viable skin - VS samples) vial.
- Microbiological Tests a) Microbial load: Testing was performed according to EP 2.6.12 and 2.6.13 as described in the European Pharmacopea. b) Preservative efficacy: Testing was performed according to USP ⁇ 51> and EP 5.6, 2007 5.1.3. as described in the European and U.S Pharmacopea.
- the test consists of challenging the product with specified microorganisms, storing the inoculated preparations at a prescribed temperature, removing the inoculated samples at specified intervals of time and counting the number of viable organisms in the withdrawn samples using a plate-count procedure.
- Formulations were challenged by introducing the following microorganisms:
- Escherichia coli ATCC no. 8739
- UVB irradiation of the skin is known inter alia to increase epidermal cell apoptosis. Specimens are treated topically then irradiated with UVB and incubated. Apoptosis activation is measured post-irradiation by measuring the extent of caspase 3 activity . The methodology is described in Example 18.
- Active agent is incubated with various excipients at one or more temperatures for a certain fixed period or to the point where degradation was suspected.
- Visual inspection is a criterion for indication of compatibility. Any change of color indicates oxidation or degradation. The methodology is described in Example 19.
- Silicone oils such as cyclomethicone are included in the formulations primarily as cosmetic agent, for their contribution to skin feeling properties. Volatile cyclomethicones can help reduce the greasy skin feeling that may be present in oleaginous formulations.
- Example 4 Oleaginous compositions containing Fatty Alcohols
- Formulations were prepared, containing various ratios of fatty acids to fatty alcohols and checked for their foaming properties, as described in Table 5b.
- the ratio of the concentrations of fatty alcohol to fatty acid influenced the foaming properties. Foams of good quality that did not collapse after 180 seconds at 36°C were obtained with a ratio of fatty alcohol : fatty acid of 3: 17 to 2: l . Foams of excellent quality were obtained when the ratio was 1 : 1. However, fairly good foams were obtained with a ratio of 5.6: 1.
- the ratio of fatty alcohol to fatty acid is about 3: 17 to about 2: 1; or about 1 :6 to about 16:3; or about 1 :7 to about 5: 1 or between any first ratio to any second ratio.
- Formulations were prepared, containing various concentrations of fatty acids and fatty alcohols with a fixed ratio of fatty alcohol to fatty acid of 1 : 1 and checked for their foaming properties, as described in Table 5c.
- Example 6 Oleaginous formulations containing Fatty alcohols, Fatty acids and Waxes
- Formulations containing a combination of fatty acids, fatty alcohols and waxes were prepared and checked for their foaming properties. As noted in Table 6a below, formulations 018 containing fatty alcohols and low amounts of stearic acid did not give rise to quality foams but generated fairly good quality foam that very quickly collapsed. Surprisingly, the addition of hydrogenated castor oil and beeswax (in formulation 019) both of which are solid waxes at room temperature, enhanced the foam quality and good quality foam that was stable at 36°C was obtained. Furthermore, formulations containing waxes feel less greasy upon application on skin. Thus, it has been discovered that waxes are useful foamer ingredients instead of fatty acids in oleaginous foams free of standard surfactants, and additionally they can enhance both the skin feeling and the foam quality.
- hydrogenated castor oil and fatty alcohol enhanced the foam quality and produced good quality foam that were stable at 36°C for more than 180 seconds, as shown in formulation 023.
- formulations 024 and 024b composed of combinations of beeswax, hydrogenated castor oil and fatty acid only without fatty alcohol generated fairly good foam that quickly collapsed. This shows the importance of the presence of both fatty alcohols and waxes in oleaginous foam compositions.
- wax such as hydrogenated caster oil or beeswax can not only be used in place of a fatty acid but it can be used to facilitate a lower level of fatty acid presence without compromising the foam properties.
- Formulations were prepared, containing various ratio of beeswax to hydrogenated castor oil, with a fixed concentration of fatty alcohol and checked for their foaming properties, as described in Table 6c.
- ratio of beeswax to hydrogenated castor oil is about or at least 1 : 1. According to one or more other embodiments the ratio may be less than 1 :1 where beeswax is more than about 2%.
- Formulations were prepared, containing various ratio of fatty alcohol to wax and checked for their foaming properties, as described in Table 6d.
- Formulations were prepared, containing various hydrophobic solvents and checked for their foaming properties. As described in Table 7 below, formulations containing substantial amounts of MCT oil (capric/caprylic triglycerides), octyldodecanol, coconut oil, PPG- 15 stearyl ether and soybean oil provided good quality foams that were stable at 36°C, as shown in formulation 025 and 026. Table 7 - Oleaginous compositions containing various MCT oil (capric/caprylic triglycerides), octyldodecanol, coconut oil, PPG- 15 stearyl ether and soybean oil provided good quality foams that were stable at 36°C, as shown in formulation 025 and 026. Table 7 - Oleaginous compositions containing various MCT oil (capric/caprylic triglycerides), octyldodecanol, coconut oil, PPG- 15 stearyl ether and soybean oil provided good quality foams that were stable at
- Foam formulations were prepared containing high amounts of oils, in combination with fatty alcohols, fatty acids and waxes, according to the general manufacturing procedure described in Example 1. As described in Table 8a, quality breakable foams were obtained in compositions containing different oils. The pre-foam formulations were viscous semi-solid primarily due to the addition of waxes and/or foam adjuvants. Upon addition of propellant, the formulations were shakable, indicating that the formulation within the aerosol canister is liquid. Table 8a - Foamable Oil Combinations with Fatty acid, Fatty alcohol and Wax
- Part B With Low Water (10% or 20%)
- Foam formulations were prepared containing high amounts of oils, low amounts of water, in combination with fatty alcohols, fatty acids and waxes, according to the general manufacturing procedure described in Example 1. As described in Table 8b, quality breakable foams were obtained in different compositions containing oils and low amounts of water, with or without fragrance. The pre-foam formulations were viscous semi-solid primarily due to the addition of waxes and/or foam adjuvants. Upon addition of propellant, the formulations were shakable, indicating that the formulation within the aerosol canister is liquid. Table 8b - Foamable Oil Combinations with Water, Fatty acid, Fatty alcohol and Wax
- formulations were prepared containing high amounts of oils and low amounts of water, in combination with fatty alcohols, fatty acids and waxes, which produced quality breakable foams.
- a foamable formulation comprising high amounts of hydrophobic solvents, low amounts of water, fatty alcohols, fatty acids and waxes, wherein the formulation generates quality breakable foam which does not collapse for more than 180 seconds at 36°C.
- the amount of water is lower than about 20%. In one or more embodiments, the amount of water is lower than about 10%. In one or more embodiments, the amount of water is lower than about 5%. In one or more embodiments, the amount of water is lower than about 2%. In one or more embodiments, the oleaginous formulation is essentially free of water.
- Foam formulations were prepared containing high amounts of Petrolatum, in combination with liquid oils, fatty alcohols and waxes, according to the general manufacturing procedure described in Example 1. As described in Table 9a, quality breakable foams were obtained in different compositions containing Petrolatum. The pre-foam formulations were viscous semi-solid. Upon addition of propellant, the formulations were shakable, indicating that the formulation within the aerosol canister is liquid.
- a foamable formulation comprising Petrolatum, optionally a liquid oil, a fatty alcohol and a wax, wherein the formulation generates quality breakable foam.
- Foam formulations were also prepared without waxes, containing high amounts of Petrolatum, in combination with liquid oils and fatty alcohols, according to the general manufacturing procedure described in Example 1. As described in Table 9b, quality breakable foams were obtained in different compositions containing Petrolatum without waxes. The pre- foam formulations were viscous semi-solid. Upon addition of propellant, the formulations were shakable, indicating that the formulation within the aerosol canister is liquid.
- a foamable formulation comprising Petrolatum, and a fatty alcohol with optionally shea butter, wherein the formulation generates quality breakable foam.
- a foamable formulation comprising Petrolatum, optionally a liquid oil, and a fatty alcohol with optionally shea butter, wherein the formulation generates quality breakable foam.
- Example 10 Oleaginous compositions containing Waxes
- Paraffin 51-53 did not give rise to high quality foams but merely generated fairly good quality foam that quickly collapsed.
- formulations C003 to C007, containing 5% or more Paraffin 51-53 alone or in combination with stearyl alcohol generated quality foams that did not quickly collapse at 36°C. Increasing the amount of wax resulted in improved collapse times.
- paraffin 51-53 was able to produce a high quality foam with a collapse time in excess of 3minutes in the absence of a fatty alcohol.
- the foamer complex can be a paraffin wax alone or in combination with a foam adjuvant.
- formulation C007 is an example of a surfactant free, hydroxyl free, acid free, water free formulation essentially free of polyols and alcohols.
- the formulations of the present disclosure provide a very small mean bubble size (74 micrometers for formulation 012 and 79 micrometers for formulation 019), which indicates a good foam quality and an extended physical stability.
- Foams with small bubble size also have improved organoleptic properties, which is of importance in order to ensure a better patient compliance and a better skin feeling.
- These foam formulations provide an easy application onto the skin, good skin absorption and do not turn into runny liquids upon rubbing. It has thus been discovered that the combination of fatty alcohol, with fatty acids and/or waxes has a clear advantages over the prior art and provides foam of improved quality, usability and stability.
- compositions where no separation or sedimentation of the ingredients is observed.
- formulation 252 the Table indicates that foam quality decreases with time under accelerated stability storage at 40°C.
- the formulations may be essentially free of lanolin, for example, where long term physical stability is required. It may be, however, that in certain other embodiments lanolin can be successfully included either in lower amounts, or by combination of lanolin with additional ingredients (such as surfactants, polymers, etc) and the formula can be physically stable in the short, medium or long term.
- the foam formulations containing propellant demonstrated an increase in the minocycline content homogeneity, which is of high importance in pharmaceutical applications in order to ensure a reproducible and accurate dose delivery.
- the propellant acts as a solvent to the hydrophobic carrier and also as a dispersing agent, by reducing the formulation viscosity within the canister.
- the potential of compounds to cause irreversible or severe eye irritation or corrosion may be detected by observing adverse changes, which occur in the chorioallantoic membrane (CAM) of the egg after exposure to test chemicals. Fertilized hen's eggs are rotated in an incubator for 9 days, after which any defective eggs are discarded. The shell around the air cell is removed and the inner membranes are extracted to reveal the chorionallantoic membrane. Test chemicals are added to the membrane and left in contact for up to 5 minutes. The membrane is examined for vascular damage and the time taken for injury to occur is recorded. Irritancy is scored according to the speed at which damage occurs. To validate the HET-CAM data, Positive & Negative Controls and Vehicle Control (if applicable), are tested in parallel to the Test Item. For each Test Item, Positive and Negative Controls, mean scores of replicate eggs is determined. Irritation Score (IS) is interpreted as follows:
- Table 18a and Table 18b demonstrate the effect of formulation 244 with 1% and 4% minocycline on epidermal cell apoptosis and viability following UVB irradiation of the skin organ culture.
- apoptosis activation was significantly decreased by formulation 244 in a dose-dependant manner.
- Cell viability as measured by the MTT assay 72 hours after irradiation was increased, as shown in Table 18b.
- One set of mediators implicated in apoptosis belong to the asparate-specific cysteinyl proteases or caspases. A member of this family, caspase-3 has been identified as being a key mediator of apoptosis of mammalian cells.
- Table 18a Effect of Formulation 244 on apoptosis activation in skin organ culture after UVB irradiation
- Specimens of human skin in organ culture were irradiated with UVB (400 mJ/cm2) and incubated for additional 72 hours. Formulation 244 4% was then applied to the skin and apoptosis activation was measured 24 h post-treatment by measuring the extent of caspase 3 activity in epidermal sheets.
- Formulations O-001 and O-002 gave homogeneous oil-gels suitable for use in ophthalmic preparations.
- the two formulations differ in their texture, formulation O-002 being more liquid due to the inclusion of high amounts of liquid oils.
- a wax or shea butter or a hydrogenation caster oil may be usefully added together with a propellant.
- Shea butter can be obtained in several different formats: Liquid, semi solid or butter like consistency. In the presence of another hydrophobic solvent good shakability of a foamable formulation with petrolatum can be obtained even with semi shea butter of solid or butter like consistency.
Abstract
Description
Claims
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US15/816,850 US10517882B2 (en) | 2009-10-02 | 2017-11-17 | Method for healing of an infected acne lesion without scarring |
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