Testosterone formulations
AssigneeFerring B.V.
InventorsArnaud Grenier, Dario N. Carrara
Life of this patent
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Abstract
The subject invention provides improved testosterone gel formulations.
Claims38
A transdermal or transmucosal formulation comprising:
- 2% wt of testosterone,
- at least one C2 to C4 alkanol,
- 15-30% wt polyalcohol, wherein the polyalcohol is one or more of a C2 to C6 alkane or C2 to C6 alkene, substituted with two or more hydroxyl groups, and
- monoalkyl ether of diethylene glycol,
- wherein said formulation is substantially free of long-chain fatty alcohols, long-chain fatty acids, and long-chain fatty esters.
A transdermal or transmucosal formulation comprising:
- 2% wt of testosterone, 44.0% wt of ethanol, 20.0% wt of propylene glycol, and 5.0% wt of diethylene glycol monoethyl ether, wherein said formulation is substantially free of long-chain fatty alcohols, long-chain fatty acids, and long-chain fatty esters.
A transdermal or transmucosal formulation comprising:
- 2% wt of testosterone, 44.0% wt of ethanol, 20.0% wt of propylene glycol, 5.0% wt of diethylene glycol monoethyl ether, 1.20% wt of carbomer, 0.35% wt of triethanolamine, 0.06% wt of edetate disodium and water wherein said formulation is substantially free of long-chain fatty alcohols, long-chain fatty acids, and long-chain fatty esters.
A transdermal or transmucosal formulation consisting of 2% wt of testosterone, 44.0% wt of ethanol, 20.0% wt of propylene glycol, 5.0% wt of diethylene glycol monoethyl ether, 1.20% wt of carbomer, 0.35% wt of triethanolamine, 0.06% wt of edetate disodium and water.
A method of treating a disease or disorder associated with reduced endogenous testosterone production in a male subject comprising:
- transdermally administering to a skin or mucosal membrane of a male subject a formulation comprising:
- 1-2% wt of testosterone, C2 to C4 alkanol, 20.0% wt of propylene glycol, and monoalkyl ether of diethylene glycol, wherein said formulation is substantially free of long-chain fatty alcohols, long-chain fatty acids, and long-chain fatty esters.
A method of treating a disease or disorder associated with reduced endogenous testosterone production in a male subject comprising:
- transdermally administering to a skin or mucosal membrane of a male subject a formulation comprising:
- 1-2% wt of testosterone, C2 to C4 alkanol, 20.0% wt of propylene glycol, monoalkyl ether of diethylene glycol, gelling agent, neutralizing agent, chelating agent and solvent, wherein said formulation is substantially free of long-chain fatty alcohols, long-chain fatty acids, and long-chain fatty esters.
A method of treating a disease or disorder associated with reduced endogenous testosterone production in a male subject comprising:
- transdermally administering to a skin or mucosal membrane of a male subject a formulation comprising 1-2% wt of testosterone, 44% wt of ethanol, 20.0% wt of propylene glycol, 5% wt of monoethyl ether of diethylene glycol, 1.20% wt of carbomer, 0.35% wt of triethanolamine, 0.06% wt of edetate disodium and water wherein the formulation is substantially free of long-chain fatty alcohols, long-chain fatty acids, and long-chain fatty esters.
A method of treating a disease or disorder associated with reduced endogenous testosterone production in a male subject comprising:
- transdermally administering to a skin or mucosal membrane of a male subject a formulation consisting of 1-2% wt of testosterone, 44% wt of ethanol, 20.0% wt of propylene glycol, 5% wt of monoethyl ether of diethylene glycol, 1.20% wt of carbomer, 0.35% wt of triethanolamine, 0.06% wt of edetate disodium and water.
Dependencies are inferred from the claim text.