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Kafe 바로가기국가/구분 | United States(US) Patent 등록 |
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국제특허분류(IPC7판) |
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출원번호 | US-0125554 (2013-01-25) |
등록번호 | US-9248136 (2016-02-02) |
국제출원번호 | PCT/US2013/023309 (2013-01-25) |
국제공개번호 | WO2013/112947 (2013-08-01) |
발명자 / 주소 |
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출원인 / 주소 |
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대리인 / 주소 |
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인용정보 | 피인용 횟수 : 3 인용 특허 : 536 |
Hormone replacement therapies are provided comprising solubilized progesterone alone and optionally with an estrogen, cyclic/sequential and continuous-combined dosing, and administered via transdermal HRT delivery systems.
1. A transdermal pharmaceutical formulation comprising progesterone and a solubilizing agent, wherein the solubilizing agent comprises an oil containing a C6-C12 fatty acid, wherein the progesterone is solubilized in the solubilizing agent and wherein the solubilized progesterone is present in a tra
1. A transdermal pharmaceutical formulation comprising progesterone and a solubilizing agent, wherein the solubilizing agent comprises an oil containing a C6-C12 fatty acid, wherein the progesterone is solubilized in the solubilizing agent and wherein the solubilized progesterone is present in a transdermal patch. 2. The transdermal pharmaceutical formulation of claim 1, wherein the oil is a monoglyceride, a diglyceride, or a triglyceride containing a C6—C12 fatty acid, and combinations thereof. 3. The transdermal pharmaceutical formulation of claim 1, wherein the solubilizing agent is selected from the group consisting of Transcutol and Miglyol; Transcutol, Miglyol and Capmul PG8; Transcutol, Miglyol and Capmul PG10; Campul MCM; and Capmul MCM and Gelucire. 4. The transdermal pharmaceutical formulation of claim 1, wherein the solubilizing agent is Capmul MCM and a non-ionic surfactant. 5. The transdermal pharmaceutical formulation of claim 4, wherein the solubilizing agent is Capmul MCM and Gelucire. 6. The transdermal pharmaceutical formulation of claim 1, wherein the daily dose of progesterone is from about 10 mg to about 100 mg per patch. 7. The transdermal pharmaceutical formulation of claim 1, wherein the daily dose of progesterone is from about 20 mg to about 80 mg per patch. 8. The transdermal pharmaceutical formulation of claim 1, wherein the daily dose of progesterone is from about 20 mg to about 30 mg per patch. 9. The transdermal pharmaceutical formulation of claim 1, wherein the transdermal patch is from about 9 cm2 to about 16 cm2 in surface area. 10. The transdermal pharmaceutical formulation of claim 1, further comprising 17β-estradiol. 11. The transdermal pharmaceutical formulation of claims 10, wherein the 17β-estradiol is solubilized. 12. The transdermal pharmaceutical formulation of claim 10, wherein the daily dose of 17β-estradiol is from about 0.01 mg to about 0.1 mg per patch. 13. A method of treating at least one progesterone-deficient state in a mammal in need of treatment comprising administering an effective amount of a transdermal pharmaceutical formulation of claim 1. 14. A method of treating at least one progesterone-deficient state and at least one estrogen-deficient state in a mammal in need of treatment comprising administering an effective amount of a transdermal pharmaceutical formulation of claim 10. 15. The method of claim 14, wherein the progesterone and the 17β-estradiol drug substance are administered in a cyclic-sequential method. 16. The method of claim 14, wherein the progesterone and the 17β-estradiol drug substance are administered in a continuous-combined method. 17. A method of treating at least one progesterone-deficient state and at least one estrogen-deficient state in a mammal in need of treatment comprising administering an effective amount of a transdermal pharmaceutical formulation of claim 1, and an effective amount of at least one estrogen drug substance wherein the estrogen drug substance is administered via a method independent of the administration of progesterone in the transdermal pharmaceutical formulation. 18. The method of claim 17, wherein the progesterone and the estrogen drug substance are administered in a cyclic-sequential method. 19. The method of claim 17, wherein the progesterone and the estrogen drug substance are administered in a continuous combined method. 20. The method of claim 17, wherein the estrogen drug substance is estradiol administered via oral administration.
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