CA2511995A1 - Pharmaceutical preparations for treatments of diseases and disorders of the breast - Google Patents

Pharmaceutical preparations for treatments of diseases and disorders of the breast Download PDF

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Publication number
CA2511995A1
CA2511995A1 CA002511995A CA2511995A CA2511995A1 CA 2511995 A1 CA2511995 A1 CA 2511995A1 CA 002511995 A CA002511995 A CA 002511995A CA 2511995 A CA2511995 A CA 2511995A CA 2511995 A1 CA2511995 A1 CA 2511995A1
Authority
CA
Canada
Prior art keywords
drug
breast
drug formulation
group
hormone
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
CA002511995A
Other languages
French (fr)
Other versions
CA2511995C (en
Inventor
Gerianne Tringali Dipiano
Peter Kevin Mays
John Ziemniak
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Femmepharma Global Healthcare Inc
Original Assignee
Individual
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to CA2764405A priority Critical patent/CA2764405A1/en
Publication of CA2511995A1 publication Critical patent/CA2511995A1/en
Application granted granted Critical
Publication of CA2511995C publication Critical patent/CA2511995C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0041Mammary glands, e.g. breasts, udder; Intramammary administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0014Skin, i.e. galenical aspects of topical compositions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/14Drugs for genital or sexual disorders; Contraceptives for lactation disorders, e.g. galactorrhoea
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00Drugs for disorders of the muscular or neuromuscular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/02Drugs for disorders of the nervous system for peripheral neuropathies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/24Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/32Antioestrogens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

Abstract

Formulations for topical or local administration of drugs directly to the breast or chest to produce a regional or local effect with lower systemic dr ug levels than when an effective amount is administered systemically are disclosed herein. In a preferred embodiment, the drug is administered to the surface of the breast, areola, or directly to the nipple. The formulations provide increased patient comfort, increased bioavailability and relatively high blood levels in the region to be treated with a reduction of side effec ts compared to those administered systemically. The preferred formulations contain drugs in the form of micro or nanoparticles, which may be formed of drug alone or in combination with an excipient or carrier. The excipient or carrier may modify the release rates or enhance absorption into the affected area. The drug formulation may be in the form of a cream, lotion of foam.</S DOAB>

Claims (19)

1. A drug formulation comprising a drug in an amount effective to provide relief from diseases or disorders of the breast in a pharmaceutically acceptable carrier for topical administration to the breast, wherein the drug is not a non-steroidal antiinflammatory or analgesic.
2. The drug formulation of claim 1 wherein the drug is soluble in aqueous solutions.
3. The drug formulation of claim 1 wherein the drug is in the form of micro- or nano-particulates.
4. The drug formulation of claim 1 wherein the carrier is selected from the group consisting of a gel, ointment, lotion, emulsion, cream, foam, mousse, liquid, spray, and aerosol.
5. The drug formulation of claim 4, wherein the carrier is a hydroalcoholic gel.
6. The drug formulation of claim 1 wherein the drug is selected from the group consisting of chemotherapeutic agents, hormones, hormone releasing agents, hormone analogs, and anti-proliferative agents.
7. The drug formulation of claim 6 wherein the drug is selected from the group consisting of danazol, bromocriptine, tamoxifen, luteinizing hormone-releasing hormone (LHRH) analogues, and antiestrogens.
8. The drug formulation of claim 6 wherein the drug is a danazol.
9. The drug formulation of claim 1 in a dosage effective to treat benign diseases of the breast.
10. A method for treating a disease or disorder of the of the breast, chest or underlying musculature comprising topically administering to the patient a drug formulation suitable for local or regional delivery comprising an effective amount of drug to provide symptomatic relief, wherein the drug is not a non-steroidal antiinflammatory or analgesic, in a dosage which results in low serum drug levels as compared to the systemic administration of the drug.
11. The method of claim 10 wherein the drug is in the form of micro-or nano-particulates.
12. The method of claim 10 wherein the carrier is selected from the group consisting of a gel, ointment, lotion, emulsion, cream, foam, mousse, liquid, spray, and aerosol.
13. The method of claim 10 wherein the drug is selected from the group consisting of chemotherapeutic agents, hormones, hormone releasing agents, hormone analogs, and anti-proliferative agents.
14. The method of claim 13 wherein the drug is selected from the group consisting of danazol, bromocriptine, tamoxifen, luteinizing hormone-releasing hormone (LHRH) analogues, and antiestrogens.
15. The method of claim 13 wherein the drug is danazol.
16. The method of claim 10 in a dosage effective to a benign disease of the breast.
17. The method of claim 16 wherein the benign disease of the breast is selected from the group consisting of mastalgia, mastodynia, Mondor's disease, fibrocystic breast disease, costochondritis, mastitis, Paget's disease of the areola, fibroadenoma, breast abscess, and breast infections.
18. The method of claim 10 wherein the drug formulation provides a dosage effective for regional treatment.
19. The method of claim 18 wherein the region is the breast, areola, and underlying musculature of the chest.
CA2511995A 2003-01-02 2004-01-02 Pharmaceutical preparations for treatments of diseases and disorders of the breast Expired - Lifetime CA2511995C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2764405A CA2764405A1 (en) 2003-01-02 2004-01-02 Pharmaceutical preparations for treatments of diseases and disorders of the breast

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US43777803P 2003-01-02 2003-01-02
US60/437,778 2003-01-02
PCT/US2004/000023 WO2004060322A2 (en) 2003-01-02 2004-01-02 Pharmaceutical preparations for treatments of diseases and disorders of the breast

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA2764405A Division CA2764405A1 (en) 2003-01-02 2004-01-02 Pharmaceutical preparations for treatments of diseases and disorders of the breast

Publications (2)

Publication Number Publication Date
CA2511995A1 true CA2511995A1 (en) 2004-07-22
CA2511995C CA2511995C (en) 2012-03-13

Family

ID=32713228

Family Applications (2)

Application Number Title Priority Date Filing Date
CA2511995A Expired - Lifetime CA2511995C (en) 2003-01-02 2004-01-02 Pharmaceutical preparations for treatments of diseases and disorders of the breast
CA2764405A Abandoned CA2764405A1 (en) 2003-01-02 2004-01-02 Pharmaceutical preparations for treatments of diseases and disorders of the breast

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA2764405A Abandoned CA2764405A1 (en) 2003-01-02 2004-01-02 Pharmaceutical preparations for treatments of diseases and disorders of the breast

Country Status (7)

Country Link
US (1) US7812010B2 (en)
EP (1) EP1578421A4 (en)
JP (2) JP2006515026A (en)
AU (1) AU2004203700B2 (en)
CA (2) CA2511995C (en)
MX (1) MXPA05007266A (en)
WO (1) WO2004060322A2 (en)

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WO2004060322A2 (en) 2004-07-22
CA2511995C (en) 2012-03-13

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