CA2418135A1 - Novel composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels - Google Patents

Novel composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels Download PDF

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Publication number
CA2418135A1
CA2418135A1 CA002418135A CA2418135A CA2418135A1 CA 2418135 A1 CA2418135 A1 CA 2418135A1 CA 002418135 A CA002418135 A CA 002418135A CA 2418135 A CA2418135 A CA 2418135A CA 2418135 A1 CA2418135 A1 CA 2418135A1
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CA
Canada
Prior art keywords
pharmaceutical composition
composition according
active agents
comprised
weight
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002418135A
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French (fr)
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CA2418135C (en
Inventor
Dario Carrara
Gabriel Porto
Jorge Rodriguez
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Antares Pharma IPL AG
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Individual
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Publication of CA2418135A1 publication Critical patent/CA2418135A1/en
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Publication of CA2418135C publication Critical patent/CA2418135C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels

Abstract

The present invention refers to a pharmaceutical composition suitable for th e transdermal or transmucosal administration of one or more active agents, in form of a gel or a solution, comprising as a permeation enhancers a combination of: a) saturated fatty alcohol of formula CH3-(CH2)n-CH2OH or saturated fatty acid CH3-(CH2)n-CH2COOH wherein n is an integer number 8 .di v. 22, preferably 8 .div. 12, most preferably 10, or unsaturated fatty alcohol or fatty acid of formula: CH3(CnH2(n-1))-OH or CH3(CnH2(n-1))-COOH wherein n is an integer number 8 .div. 22, b) a ternary vehicle or carrier consisting of a C1 .div. C4 alkanol, a polyalcohol in particular propylenglycol and water, c ) optionally also a monoalkylether of diethylenglycol.

Claims (10)

1. Pharmaceutical composition suitable for the transdermal or transmucosal administration of one or more active agents, in form of a gel or a solution, comprising as a permeation enhancers a combination of:
a) saturated fatty alcohol of formula CH3-(CH2)n-CH2OH or saturated fatty acid (CH2)n-CH2COOH wherein n is an integer number 8 ÷ 22, preferably 8 ÷
12, most preferably 10, or unsaturated fatty alcohol or fatty acid of formula:
CH3(C n H2(n-1))-OH or CH3(C n H2(n-1))-COOH wherein n is an integer number 8 ÷ 22, b) a ternary vehicle or carrier consisting of a C1 ÷ C4 alkanol, a polyalcohol in particular propylenglycol and water, c) optionally also a monoalkylether of diethylenglycol.
2. Pharmaceutical composition according to claim 1 wherein the active agents are comprised in the class of estrogen hormons.
3. Pharmaceutical composition according to claim 1 wherein the active agents are comprised in the class of androgen hormons.
4. Pharmaceutical composition according to claim 1 wherein the active agents are sedatives and anxyolitics of the type benzodiazepine or amides such as Butoctamide, diethylbromoacetamide, isovaleryl-diethylamide.
5. Pharmaceutical composition according to claim 1 wherein the active agents are antihypothyroid hormones.
6. Pharmaceutical composition according to claim 1 wherein the active agents are antihypertensive.
7. Pharmaceutical composition according to claim 1 wherein the active agents are calcium regulators, such as Calcitonin, Calcifediol, parathyroid hormone.
8. Pharmaceutical composition according to claim 1, wherein:
- the component a) is in amount comprised between 0.1% and 20% by weight (preferably 0.2 ÷ 3%), - the component b) comprises 5% ÷ 75% by weight of alkanol on the whole composition and 0.5% ÷ 50% of a glycol, - the component c) is in amount up to 40% by weight (preferably 2 ÷ 8%),
9. Pharmaceutical composition according to claim 1 or 2 in form of gel, comprising, as gelling agent:
- a polyacrylic acid such as carbopol - a cellulose derivative such as hydroxypropylmethylcellulose, carboxymethylcellulose, ethylhydroxyethylcellulose, hydroxypropylcellulose, hydroxyethylcellulose - polyvinylpyrrolidone - polyoxyethylene/polyoxypropylene copolymers - polyvinylalcohol - natural gums, alginates, pectins.
10. Pharmaceutical composition according to claim 3 wherein the amount of gelling agent is comprised between 0.2 and 30% by weight.
CA2418135A 2000-08-03 2001-08-03 Novel composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels Expired - Fee Related CA2418135C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP0007533 2000-08-03
EPPCT/EP00/07533 2000-08-03
PCT/EP2001/009007 WO2002011768A1 (en) 2000-08-03 2001-08-03 Novel composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels

Publications (2)

Publication Number Publication Date
CA2418135A1 true CA2418135A1 (en) 2002-02-14
CA2418135C CA2418135C (en) 2011-09-20

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA2418135A Expired - Fee Related CA2418135C (en) 2000-08-03 2001-08-03 Novel composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels

Country Status (12)

Country Link
US (2) US7214381B2 (en)
EP (4) EP1323430B1 (en)
JP (1) JP2004505931A (en)
KR (1) KR100856523B1 (en)
AR (1) AR030312A1 (en)
AT (3) ATE485837T1 (en)
AU (2) AU8206401A (en)
CA (1) CA2418135C (en)
DE (3) DE60143360D1 (en)
ES (2) ES2283425T3 (en)
NZ (1) NZ524423A (en)
WO (1) WO2002011768A1 (en)

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