Claims for Patent: 4,855,294

Summary for Patent: 4,855,294

Title:	Method for reducing skin irritation associated with drug/penetration enhancer compositions
Abstract:	A composition and method for reducing the skin irritation properties of a transdermal drug/enhancer composition which comprises incorporating into said composition, either prior to or at the time of application the skin, an effective amount of glycerin. When incorporated into the drug/enhancer composition prior to application to the skin the glycerin content will be between about 0.1 and 70 wt. %, preferably between about 1.0 and 50 wt. % and most preferably between about 5.0 and 20 wt. % of the composition.
Inventor(s):	Patel; Dinesh C. (Murray, UT), Ebert; Charles D. (Salt Lake City, UT)
Assignee:	TheraTech, Inc. (Salt Lake City, UT)
Application Number:	07/240,688
Patent Claims:	1. A drug-enhancer composition for transdermally administering a drug having reduced skin irritation properties consisting essentially of (a) a percutaneously absorbable drug, (b) a mild to moderately irritating enhancer composition consisting of a solvent selected from the group consisting of a C.sub.2 or C.sub.3 alcohol, a C.sub.3 or C.sub.4 diol, DMSO, DMF, DMA, 1-n-dodecyl-cyclazacycloheptan-2-one, N-methyl-pyrrolidone and N-(2-hydroxyethyl)pyrrolidone and mixtures thereof and an effective enhancing amount of a cell envelope disordering compound and (c) an effective amount of glycerin to reduce the irritation of said drug-enhancer composition. 2. The composition of claim 1 wherein glycerin is present in an amount of between about 0.1 and 70.0 wt. %. 3. The composition of claim 1 wherein glycerin is present in an amount of between about 1.0 and 50.0 wt. %. 4. The composition of claim 1 wherein glycerin is present in an amount of between abut 5.0 and 20.0 wt. %. 5. The composition of claim 2 wherein the cellenvelope disordering compounds is a member selected from the group consisting of methyl laurate, oleic acid, oleyl alcohol, glycerol monooleate, glycerol dioleate and glycerol trioleate and mixtures thereof. 6. The composition according to claim 5 wherein the enhancer composition contains ethanol. 7. The composition according to claim 5 wherein the enhancer composition contains DMSO. 8. The composition according to claim 6 wherein the enhancer composition contains methyl laurate. 9. The composition according to claim 6 wherein the enhancer composition contains glycerol dioleate. 10. The composition according to claim 6 wherein the enhancer composition contains glycerol monoleate. 11. The composition according to claim 6 wherein the enhancer composition contains propylene glycol. 12. The composition according to claim 11 wherein the enhancer composition contains 1-dodecyl-azacycloheptan-2-one. 13. The composition according to claim 5 wherein the enhancer composition contains propylene glycol. 14. The composition according to claim 13 wherein the enhancer composition contains oleic acid. 15. A method for reducing skin irritation caused by drug-enhancer compositions having skin irritation properties comprising applying to a predetermined area of skin an effective amount of a drug/enhancer composition consisting essentially of a percutaneously absorbable drug, (b) a mild to moderately irritating enhancer composition consisting of a solvent selected from the group consisting of a C.sub.2 or C.sub.3 alcohol, a C.sub.3 or C.sub.4 diol, DMSO, DMF, DMA, 1-n-dodecyl-cyclazacycloheptan-2-one, N-methyl-pyrrolidone and N-(2-hydroxyethyl)pyrrolidone and mixtures thereof and an effective enhancing amount of a cell envelope disordering compound and (c) an effective amount of glycerin to reduce the irritation of said drug-enhancer composition. 16. The method of claim 15, wherein the drug-enhancer composition contains between about 0.1 and 70 wt. % glycerin. 17. The method of claim 15, wherein the drug-enhancer composition contains between about 1.0 and 50 wt. % glycerin. 18. The method of claim 15, wherein the drug-enhancer composition contains between about 5.0 and 20.0 wt. % glycerin. 19. The method of claim 17 wherein the cell envelope disordering compound is a member selected from the group consisting of methyl laurate, oleic acid, oleyl alcohol, glycerol monooleate, glycerol dioleate and glycerol trioleate and mixtures thereof. 20. The method of claim 19 wherein the glycerin containing drug-enhancer composition is administered to an afflicted situs. 21. The method of claim 19 wherein the glycerin containing drug-enhancer composition is administered to an application situs.