Method and composition for transdermal drug delivery
DC CAFC
First Claim
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1. A method of increasing the testosterone blood level of an adult male subject in need thereof comprising applying to at least one axilla of the subject, without occlusion by a patch device, a non-occlusive transdermal drug delivery composition consisting of:
- (a) a pharmaceutically effective amount of testosterone;
(b) one or more lower alkyl alcohols, wherein the combined volume of the lower alkyl alcohols is more than 60% (v/v) of the composition;
(c) one or more penetration enhancers selected from the group consisting of glycols, oleic acid, isopropyl myristate, cyclopentadecanone, sorbitan monooleate, octisalate, octyldimethyl-para-aminobenzoate, octyl para-methoxycinnamate, and combinations thereof;
(d) one or more viscosity modulating agents;
(e) optionally, an activator for the viscosity modulating agent;
(f) optionally, an antiperspirant and/or deodorant agent; and
(g) optionally, waterwherein the composition is applied in an amount effective to achieve a testosterone blood level in the subject of at least 200 ng/dL.
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Abstract
The invention is directed to a transdermal drug delivery composition which includes at least one physiologically active agent; and at least one volatile solvent; and at least one viscosity modulating agent. The invention extends to methods of administering such a composition to a subject and treatment of subjects using the composition.
80 Citations
21 Claims
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1. A method of increasing the testosterone blood level of an adult male subject in need thereof comprising applying to at least one axilla of the subject, without occlusion by a patch device, a non-occlusive transdermal drug delivery composition consisting of:
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(a) a pharmaceutically effective amount of testosterone; (b) one or more lower alkyl alcohols, wherein the combined volume of the lower alkyl alcohols is more than 60% (v/v) of the composition; (c) one or more penetration enhancers selected from the group consisting of glycols, oleic acid, isopropyl myristate, cyclopentadecanone, sorbitan monooleate, octisalate, octyldimethyl-para-aminobenzoate, octyl para-methoxycinnamate, and combinations thereof; (d) one or more viscosity modulating agents; (e) optionally, an activator for the viscosity modulating agent; (f) optionally, an antiperspirant and/or deodorant agent; and (g) optionally, water wherein the composition is applied in an amount effective to achieve a testosterone blood level in the subject of at least 200 ng/dL. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. A method of increasing the testosterone blood level of an adult male subject in need thereof comprising applying to at least one axilla of the subject, without occlusion by a patch device, a non-occlusive transdermal drug delivery composition consisting of:
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(a) a pharmaceutically effective amount of testosterone; (b) one or more lower alkyl alcohols, wherein the combined volume of the lower alkyl alcohol(s) is more than 60% (v/v) of the composition; (c) one or more penetration enhancers selected from the group consisting of octisalate, octyldimethyl-para-aminobenzoate and octyl para-methoxycinnamate; (d) one or more viscosity modulating agents, in an amount effective to increase the viscosity of the composition to within the range of from greater than the viscosity of water to less than 300 centipoise; and (e) optionally, water wherein the composition is applied in an amount effective to achieve a testosterone blood level in the subject of at least 200 ng/dL. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20, 21)
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Specification
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Litigation Data
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Current AssigneeAcrux DDS Pty Ltd (Acrux Limited)
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Original AssigneeAcrux DDS Pty Ltd (Acrux Limited)
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InventorsDipietro, Tony, Humberstone, Andrew, Gonda, Igor, Watkinson, Adam, Setiawan, Kerrie, Wilkins, Nina
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Primary Examiner(s)Roberts, Lezah
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Assistant Examiner(s)Holloman, Nannette
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Application NumberUS11/445,463Publication NumberTime in Patent Office2,531 DaysField of Search514/10.2, 514/177, 514/178US Class Current514/10.2CPC Class CodesA61K 31/568 substituted in positions 10...A61K 47/10 Alcohols; Phenols; Salts th...A61K 47/12 Carboxylic acids; Salts or ...A61K 47/14 Esters of carboxylic acids,...A61K 47/32 Macromolecular compounds ob...A61K 8/37 Esters of carboxylic acidsA61K 9/0014 Skin, i.e. galenical aspect...A61P 15/00 Drugs for genital or sexual...A61P 17/00 Drugs for dermatological di...A61P 5/24 of the sex hormonesA61P 5/26 AndrogensA61Q 17/04 Topical preparations for af...
