Testosterone transdermal spray with film
AssigneeCelista Pharmaceuticals LLC
InventorsYogesh DANDIKER, Maulik K. PANCHAL
Life of this patent
Estimating the term…
Abstract
The invention relates to a sprayable liquid solution for the transdermal delivery of testosterone comprising testosterone, a penetration enhancer, and a film forming excipient, and to methods of treatment using this composition.
Claims17
1-56. (canceled)
A composition comprising
- a. 10% to 25% w/w testosterone;
- b. one or more penetration enhancers;
- c. one or more solvents;
- d. about 4% to about 8% poly(butylmethacrylate-co-(2-dimethylaminoethyl)methacrylate-co-methyl methacrylate 1:2:1;
- and
- e. one or more washability enhancers, wherein the washability enhancer is about 8% to about 20% the weight of the film forming excipient,
- wherein the film forming excipient (i) has a solubility in water, at a pH between 1 and 10, that requires 30 parts or less of water to dissolve one part of the film forming excipient, (ii) has a solubility in ethanol that requires 30 parts or less of ethanol to dissolve one part of the film forming excipient, and (iii) can prevent crystallization of the testosterone and maintain the testosterone in an amorphous state during solvent evaporation when the composition is applied to skin, and wherein the composition is a sprayable liquid solution.
A composition comprising (a) at least about 12% w/w testosterone, (b) one or more penetration enhancers selected from the group consisting of azone, glycerol monooleate, isopropyl myristate, octisalate, oleic acid, and diethylene glycol monoethyl ether, (c) one or more solvents selected from the group consisting of acetone, ethanol, and isopropyl alcohol, (d) about 4% to about 8% of poly(butylmethacrylate-co-(2-dimethylaminoethyl)methacrylate-co-methyl methacrylate 1:2:1, and (e) one or more washability enhancers, wherein the washability enhancer is about 8% to about 20% the weight of the film forming excipient.
A composition comprising (a) at least 10% w/w testosterone, (b) about 4% to about 8% poly(butylmethacrylate-co-(2-dimethylaminoethyl)methacrylate-co-methyl methacrylate 1:2:1, (c) a washability enhancer, and (d) a penetration enhancer, wherein the composition is a sprayable liquid.
Dependencies are inferred from the claim text.