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 PDFInfo
- 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
Links
- 210000000481 breast Anatomy 0.000 title claims abstract 10
- 238000011282 treatment Methods 0.000 title claims 2
- 208000037765 diseases and disorders Diseases 0.000 title 1
- 239000000825 pharmaceutical preparation Substances 0.000 title 1
- 229940079593 drug Drugs 0.000 claims abstract 19
- 239000003814 drug Substances 0.000 claims abstract 19
- 239000013583 drug formulation Substances 0.000 claims abstract 12
- 210000004883 areola Anatomy 0.000 claims abstract 3
- 210000000038 chest Anatomy 0.000 claims abstract 3
- 239000006071 cream Substances 0.000 claims abstract 3
- 239000006260 foam Substances 0.000 claims abstract 3
- 239000006210 lotion Substances 0.000 claims abstract 3
- 238000000034 method Methods 0.000 claims 10
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 7
- 201000010099 disease Diseases 0.000 claims 5
- 108700012941 GNRH1 Proteins 0.000 claims 4
- 239000000579 Gonadotropin-Releasing Hormone Substances 0.000 claims 4
- NKANXQFJJICGDU-QPLCGJKRSA-N Tamoxifen Chemical class C=1C=CC=CC=1C(/CC)=C(C=1C=CC(OCCN(C)C)=CC=1)/C1=CC=CC=C1 NKANXQFJJICGDU-QPLCGJKRSA-N 0.000 claims 4
- 239000003795 chemical substances by application Substances 0.000 claims 4
- POZRVZJJTULAOH-LHZXLZLDSA-N danazol Chemical class C1[C@]2(C)[C@H]3CC[C@](C)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=CC2=C1C=NO2 POZRVZJJTULAOH-LHZXLZLDSA-N 0.000 claims 4
- 229960000766 danazol Drugs 0.000 claims 4
- 229940088597 hormone Drugs 0.000 claims 4
- 239000005556 hormone Substances 0.000 claims 4
- 206010006298 Breast pain Diseases 0.000 claims 2
- 241000195940 Bryophyta Species 0.000 claims 2
- 208000006662 Mastodynia Diseases 0.000 claims 2
- 239000000443 aerosol Substances 0.000 claims 2
- 230000000202 analgesic effect Effects 0.000 claims 2
- 229940046836 anti-estrogen Drugs 0.000 claims 2
- 230000001833 anti-estrogenic effect Effects 0.000 claims 2
- 230000003110 anti-inflammatory effect Effects 0.000 claims 2
- 230000001028 anti-proliverative effect Effects 0.000 claims 2
- 239000002246 antineoplastic agent Substances 0.000 claims 2
- OZVBMTJYIDMWIL-AYFBDAFISA-N bromocriptine Chemical class C1=CC(C=2[C@H](N(C)C[C@@H](C=2)C(=O)N[C@]2(C(=O)N3[C@H](C(N4CCC[C@H]4[C@]3(O)O2)=O)CC(C)C)C(C)C)C2)=C3C2=C(Br)NC3=C1 OZVBMTJYIDMWIL-AYFBDAFISA-N 0.000 claims 2
- 229960002802 bromocriptine Drugs 0.000 claims 2
- 229940127089 cytotoxic agent Drugs 0.000 claims 2
- 208000035475 disorder Diseases 0.000 claims 2
- 239000000839 emulsion Substances 0.000 claims 2
- 239000000328 estrogen antagonist Substances 0.000 claims 2
- 239000000499 gel Substances 0.000 claims 2
- 239000003668 hormone analog Substances 0.000 claims 2
- 239000007788 liquid Substances 0.000 claims 2
- 235000011929 mousse Nutrition 0.000 claims 2
- 239000002674 ointment Substances 0.000 claims 2
- 239000007921 spray Substances 0.000 claims 2
- 230000003637 steroidlike Effects 0.000 claims 2
- 229960001603 tamoxifen Drugs 0.000 claims 2
- 206010001233 Adenoma benign Diseases 0.000 claims 1
- 206010006261 Breast infections Diseases 0.000 claims 1
- 206010011219 Costochondritis Diseases 0.000 claims 1
- 208000007659 Fibroadenoma Diseases 0.000 claims 1
- 208000000571 Fibrocystic breast disease Diseases 0.000 claims 1
- 208000010191 Osteitis Deformans Diseases 0.000 claims 1
- 208000027868 Paget disease Diseases 0.000 claims 1
- 206010034902 Phlebitis superficial Diseases 0.000 claims 1
- 208000026317 Tietze syndrome Diseases 0.000 claims 1
- 239000007864 aqueous solution Substances 0.000 claims 1
- 201000003516 breast abscess Diseases 0.000 claims 1
- 201000003149 breast fibroadenoma Diseases 0.000 claims 1
- 208000011803 breast fibrocystic disease Diseases 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 208000027202 mammary Paget disease Diseases 0.000 claims 1
- 208000004396 mastitis Diseases 0.000 claims 1
- 210000002966 serum Anatomy 0.000 claims 1
- 238000007910 systemic administration Methods 0.000 claims 1
- 238000011200 topical administration Methods 0.000 claims 1
- 238000009472 formulation Methods 0.000 abstract 3
- 239000000203 mixture Substances 0.000 abstract 3
- 239000000546 pharmaceutical excipient Substances 0.000 abstract 2
- 238000010521 absorption reaction Methods 0.000 abstract 1
- 230000036765 blood level Effects 0.000 abstract 1
- 230000000694 effects Effects 0.000 abstract 1
- 239000011859 microparticle Substances 0.000 abstract 1
- 239000002105 nanoparticle Substances 0.000 abstract 1
- 210000002445 nipple Anatomy 0.000 abstract 1
- 230000009885 systemic effect Effects 0.000 abstract 1
- 230000000699 topical effect Effects 0.000 abstract 1
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
- A61K9/0041—Mammary glands, e.g. breasts, udder; Intramammary administration
-
- 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
- A61K31/435—Heterocyclic 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
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
-
- 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
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/14—Drugs for genital or sexual disorders; Contraceptives for lactation disorders, e.g. galactorrhoea
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
- A61P5/32—Antioestrogens
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/02—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 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.
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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2004
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CA2764405A1 (en) | 2004-07-22 |
AU2004203700B2 (en) | 2007-06-21 |
AU2004203700A1 (en) | 2004-07-22 |
WO2004060322A3 (en) | 2005-04-07 |
JP2009280627A (en) | 2009-12-03 |
JP2006515026A (en) | 2006-05-18 |
MXPA05007266A (en) | 2006-01-17 |
EP1578421A2 (en) | 2005-09-28 |
US20040229813A1 (en) | 2004-11-18 |
US7812010B2 (en) | 2010-10-12 |
EP1578421A4 (en) | 2009-04-22 |
WO2004060322A2 (en) | 2004-07-22 |
CA2511995C (en) | 2012-03-13 |
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