Testosterone gel compositions and related methods
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61K-031/568
A61K-047/32
A61K-031/56
A61K-009/00
A61K-009/06
A61K-047/10
A61K-047/14
A61K-047/22
출원번호
US-0081402
(2016-03-25)
등록번호
US-9662340
(2017-05-30)
발명자
/ 주소
Pimplaskar, Harish K.
출원인 / 주소
UPSHER-SMITH LABORATORIES, INC.
대리인 / 주소
Kagan Binder, PLLC
인용정보
피인용 횟수 :
0인용 특허 :
16
초록▼
Described are gel compositions containing active pharmaceutical ingredient such as testosterone, solvent, and thickener, the gel compositions being useful for transdermal administration of the active ingredient to a patient, and related methods. Certain embodiments of the gel composition specificall
Described are gel compositions containing active pharmaceutical ingredient such as testosterone, solvent, and thickener, the gel compositions being useful for transdermal administration of the active ingredient to a patient, and related methods. Certain embodiments of the gel composition specifically exclude Hsieh enhancer.
대표청구항▼
1. A method for treating hypogonadism in a patient, the method comprising applying a pharmaceutical gel composition on a patient's skin, wherein the composition comprises: about 0.5 to about 10 weight percent testosterone; lower alcohol; cosolvent system consisting essentially of diisopropyl adipate
1. A method for treating hypogonadism in a patient, the method comprising applying a pharmaceutical gel composition on a patient's skin, wherein the composition comprises: about 0.5 to about 10 weight percent testosterone; lower alcohol; cosolvent system consisting essentially of diisopropyl adipate, methyl laurate, and oleyl alcohol, and being present in an amount in a range from about 2 to about 10 weight percent; polyol system being present in an amount in a range from about 7 to about 14 weight percent; gel-forming polymer; purified water; and optional pH-modifier; wherein the weight percent is based on total weight of the pharmaceutical gel composition. 2. The method of claim 1, wherein the lower alcohol consists essentially of ethanol, isopropanol, or a combination thereof. 3. The method of claim 1, wherein the composition comprises about 0.5 to about 2 weight percent testosterone. 4. The method of claim 1, wherein the cosolvent system consists of diisopropyl adipate, methyl laurate, and oleyl alcohol in a ratio from (0.8-1.2) to (0.1-0.7) to 1. 5. The method of claim 1, wherein the cosolvent system consists of diisopropyl adipate, methyl laurate, and oleyl alcohol in a ratio from 6:1:6. 6. The method of claim 1, wherein the polyol system consists essentially of glycerine, propylene glycol, and polyethylene glycol. 7. The method of claim 1, wherein the polyol system consists essentially of about 3 to about 7 weight percent glycerine, about 3 to about 7 weight percent propylene glycol, and about 0.3 to about 0.7 weight percent polyethylene glycol, based on total weight of the pharmaceutical gel composition. 8. The method of claim 1, wherein the composition excludes a Hseih enhancer. 9. The method of claim 1, wherein the composition excludes isopropyl myristate. 10. The method or claim 1, wherein the composition consists essentially of: about 0.5 to about 5 weight percent testosterone;from about 75 to about 85 weight percent ethyl alcohol;from about 2 to about 10 weight percent cosolvent system consisting of diisopropyl adipate, methyl laurate, and oleyl alcohol,about 7 to about 14 weight percent polyol system;gel-forming polymer;purified water; andoptional pH-modifier, based on total weight of the pharmaceutical gel composition. 11. The method or claim 1, wherein the composition consists essentially of: about 0.5 to about 10 weight percent testosterone;from about 75 to about 85 weight percent ethyl alcohol;cosolvent system consisting of from about 2 to about 10 weight percent cosolvent system consisting of diisopropyl adipate, methyl laurate, and oleyl alcohol,about 7 to about 14 weight percent polyol system consisting of glycerine, propylene glycol, and polyethylene glycol;gel-forming polymer;purified water; andoptional pH-modifier, based on total weight of the pharmaceutical gel composition. 12. The method of claim 1, further comprising maintaining the composition on the skin for period of time sufficient to deliver an amount of circulating testosterone (AUC0-24) to the patient's blood stream in a 24-hour period following the application that is about 46,000 to about 95,000 pg·h/mL (picogram-hour/milliliter) greater than the amount of circulating testosterone (AUC0-24) in the patient's blood serum achieved in the same 24-hour period without the application. 13. The method of claim 1, wherein the patient's skin is selected from shoulder, upper arm, axilla, upper torso, thigh, or a combination thereof. 14. A pharmaceutical gel composition comprising: about 0.5 to about 10 weight percent testosterone; lower alcohol; cosolvent system consisting essentially of diisopropyl adipate, methyl laurate, and oleyl alcohol, and being present in an amount in a range from about 2 to about 10 weight percent; polyol system being present in an amount in a range from about 7 to about 14 weight percent; gel-forming polymer; purified water; and optional pH-modifier; wherein the weight percent is based on total weight of the pharmaceutical gel composition. 15. The pharmaceutical composition of claim 14, wherein the cosolvent system consists of diisopropyl adipate, methyl laurate, and oleyl alcohol in a ratio from (0.8-1.2) to (0.1-0.7) to 1. 16. The pharmaceutical composition of claim 14, wherein the cosolvent system consists of diisopropyl adipate, methyl laurate, and oleyl alcohol in a ratio from 6:1:6. 17. The pharmaceutical composition of claim 14, wherein the polyol system consists essentially of about 3 to about 7 weight percent glycerine, about 3 to about 7 weight percent propylene glycol, and about 0.3 to about 0.7 weight percent polyethylene glycol, based on total weight of the pharmaceutical gel composition. 18. The pharmaceutical composition of claim 14, wherein the composition consists essentially of: about 0.5 to about 5 weight percent testosterone;from about 75 to about 85 weight percent ethyl alcohol;from about 2 to about 10 weight percent cosolvent system consisting of diisopropyl adipate, methyl laurate, and oleyl alcohol;about 7 to about 14 weight percent polyol system consisting of glycerine, propylene glycol, and polyethylene glycol;gel-forming polymer;purified water; andoptional pH-modifier; based on total weight of the pharmaceutical gel composition.
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이 특허에 인용된 특허 (16)
Scholz Matthew T. ; Asmus Robert A. ; Hedenstrom John C., Hydroalcoholic compositions for transdermal penetration of pharmaceutical agents.
Ebert Charles D. (Salt Lake City UT) Patel Dinesh (Murray UT) Heiber Werner (Salt Lake City UT), Method and device for transdermally administering testosterone across nonscrotal skin at therapeutically effective level.
Patel Dinesh C. (Murray UT) Chang Yunik (Lakewood NJ), Penetration enhancement with binary system of oleic acid, oleins, and oleyl alcohol with lower alcohols.
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