Pharmaceutical composition
First Claim
Patent Images
1. A pharmaceutical composition comprising:
- (A) an androgen;
(B) a Hsieh enhancer; and
(C) a thickening agent.
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Accused Products
Abstract
A pharmaceutical composition comprising: (A) an androgen; (B) a cyclic enhancer of the type used in the compositions and methods claimed by U.S. Pat. No. 5,023,252 to Hsieh; and (C) a thickening agent; including, for example, a composition in which the cyclic enhancer is a macrocyclic ester or a macrocyclic ketone; the use of the composition to treat a condition, for example, male hypogonadism, in a patient by applying the composition to the membrane of the patient; and a method for making the composition.
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Citations
53 Claims
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1. A pharmaceutical composition comprising:
- (A) an androgen;
(B) a Hsieh enhancer; and
(C) a thickening agent. - View Dependent Claims (6, 7, 8, 13, 14, 16, 17, 18, 21, 23, 24, 25, 28, 29, 30, 31, 33, 34, 37, 39, 40, 41, 42, 49)
- (A) an androgen;
- 2. A unit dose formulation which is effective in supplying testosterone transdermally to the blood of a male patient such that, following a single application of the unit dose to the patient, the amount of circulating testosterone (AUC0-24) in the blood serum of the patient achieved in the 24-hour period following the application is about 100 to about 35,000 ng.h/dL greater than the amount of circulating testosterone (AUC0-24) in the blood serum of the patient that would have been achieved in the same 24-hour period had the dose not been administered, said unit dose comprising up to about 1% by weight testosterone, about 0.01 to about 25% by weight of a Hsieh enhancer, and about 0.1 to about 10% by weight of thickening agent, said testosterone being present in said unit dose in an amount of about 1 to about 300 mg.
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3. A unit dose formulation which is effective in supplying testosterone transdermally to the blood of a female patient such that, following a single application of the unit dose to the patient, the amount of circulating testosterone (AUC0-24) in the blood serum of the patient achieved in the 24-hour period following the application is about 0.10 to about 11,700 ng.h/dL greater than the amount of circulating testosterone (AUC0-24) in the blood serum of the patient that would have been achieved in the same 24-hour period had the dose not been administered, said unit dose comprising up to about 1% by weight testosterone, about 0.01 to about 25% by weight of a Hsieh enhancer, and about 0.1 to about 10% by weight of thickening agent, said testosterone being present in said unit dose in an amount of about 0.01 to about 100 mg.
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4. A unit dose formulation which is effective in supplying dihydrotestosterone transdermally to the blood of a male patient such that, following a single application of the unit dose to the patient, the amount of circulating dihydrotestosterone (AUC0-24) in the blood serum of the patient achieved in the 24-hour period following the application is about 11,625 to about 465,000 pg.h/mL greater than the amount of circulating dihydrotestosterone (AUC0-24) in the blood serum of the patient that would have been achieved in the same 24-hour period had the dose not been administered, said unit dose comprising up to about 1% by weight dihydrotestosterone, about 0.01 to about 25% by weight of a Hsieh enhancer, and about 0.1 to about 10% by weight of thickening agent, said dihydrotestosterone being present in said unit dose in an amount of about 5 to about 200 mg.
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5. A unit dose formulation which is effective in supplying dihydrotestosterone transdermally to the blood of a female patient such that, following a single application of the unit dose to the patient, the average dihydrotestosterone concentration (AUC0-24) in the blood serum of the patient achieved in the 24-hour period following the application is about 11.6 about 232,500 pg.h/mL greater than the average dihydrotestosterone concentration (AUC0-24) in the blood serum of the patient that would have been achieved in the same 24-hour period had the dose not been administered, said unit dose comprising up to about 1% by weight dihydrotestosterone, about 0.01 to about 25% by weight of a Hsieh enhancer, and about 0.1 to about 10% by weight of thickening agent, said dihydrotestosterone being present in said unit dose in an amount of about 0.005 to about 100 mg.
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9-12. -12. (canceled)
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15. (canceled)
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19-20. -20. (canceled)
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22. (canceled)
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26-27. -27. (canceled)
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32. (canceled)
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35-36. -36. (canceled)
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38. A pharmaceutical composition comprising:
- (A) about 0.01 to about 15% by weight androgen;
(B) about 1 to about 15% by weight of a Hsieh enhancer; and
(C) about 1 to about 6% by weight of thickening agent. - View Dependent Claims (53)
- (A) about 0.01 to about 15% by weight androgen;
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48. A method for making a composition useful for treating a condition in a patient comprising the step of mixing an androgen, a Hsieh enhancer, and a thickening agent.
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50-52. -52. (canceled)
Specification