Pharmaceutical preparations for treatments of diseases and disorders of the breast

• US 20040229813A1
• Filed: 01/02/2004
• Published: 11/18/2004
• Est. Priority Date: 01/02/2003
• Status: Active Grant

• Current Assignee: FemmePharma Global Healthcare, Inc. (Apollo Global Management, Inc.)
• Original Assignee: Femme Pharma Incorporated
• Inventors: Mays, Peter Kevin, DiPiano, Gerianne Tringali
• Granted Patent: US 7,812,010 B2
• Time in Patent Office: Days
• US Class Current: 514/17
• CPC Class Codes: A61K 31/445 Non condensed piperidines, e.g. piperocaine
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61K 9/0041 Mammary glands, e.g. breasts, udder; Intramammary administration
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 15/14 for lactation disorders, e.g. galactorrhoea
• CPC Class Codes: A61P 21/00 Drugs for disorders of the muscular or neuromuscular system
• CPC Class Codes: A61P 25/02 for peripheral neuropathies
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 5/32 Antioestrogens
• CPC Class Codes: A61P 7/02 Antithrombotic 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 drug 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 effects 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 or foam.

Claims

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.