US4855294A
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US
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Method for reducing skin irritation associated with drug/penetration enhancer compositions
Assignee: Actavis Laboratories UT Inc
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Filing: 1988-09-06
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Granted: 1989-08-08
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Expires: 2008-09-06
Abstract
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.
Inventors
- 👤 Dinesh C. Patel
- 👤 Charles D. Ebert
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-27 04:21
CPC Classifications
A; A61; A61K; A61K47/00; A61K47/06; A61K47/08; A61K47/12; A61K31/00; A61K31/045; A61K31/047; A61K47/10; A61K47/14; A61K47/20; A61K47/22; A61K9/00; A61K9/0012; A61K9/0014
Claims Analysis
Total Claims: 23
Claim 1
Independent Claim
89 words
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 2 or C 3 alcohol, a C 3 or C 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.
Claim 2
Dependent Claim
89 words
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 2 or C 3 alcohol, a C 3 or C 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.
Claim 3
Dependent Claim
20 words
The composition of claim 1 wherein glycerin is present in an amount of between about 0.1 and 70.0 wt. %.
Claim 4
Dependent Claim
20 words
The composition of claim 1 wherein glycerin is present in an amount of between about 1.0 and 50.0 wt. %.
Claim 5
Dependent Claim
20 words
The composition of claim 1 wherein glycerin is present in an amount of between abut 5.0 and 20.0 wt. %.
Claim 6
Dependent Claim
35 words
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.
Claim 7
Dependent Claim
12 words
The composition according to claim 5 wherein the enhancer composition contains ethanol.
Claim 8
Dependent Claim
12 words
The composition according to claim 5 wherein the enhancer composition contains DMSO.
Claim 9
Dependent Claim
13 words
The composition according to claim 6 wherein the enhancer composition contains methyl laurate.
Claim 10
Dependent Claim
13 words
The composition according to claim 6 wherein the enhancer composition contains glycerol dioleate.
Claim 11
Dependent Claim
13 words
The composition according to claim 6 wherein the enhancer composition contains glycerol monoleate.
Claim 12
Dependent Claim
13 words
The composition according to claim 6 wherein the enhancer composition contains propylene glycol.
Claim 13
Dependent Claim
12 words
The composition according to claim 11 wherein the enhancer composition contains 1-dodecyl-azacycloheptan-2-one.
Claim 14
Dependent Claim
13 words
The composition according to claim 5 wherein the enhancer composition contains propylene glycol.
Claim 15
Dependent Claim
13 words
The composition according to claim 13 wherein the enhancer composition contains oleic acid.
Claim 16
Independent Claim
104 words
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 2 or C 3 alcohol, a C 3 or C 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.
Claim 17
Independent Claim
104 words
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 2 or C 3 alcohol, a C 3 or C 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.
Claim 18
Dependent Claim
18 words
The method of claim 15, wherein the drug-enhancer composition contains between about 0.1 and 70 wt. % glycerin.
Claim 19
Dependent Claim
18 words
The method of claim 15, wherein the drug-enhancer composition contains between about 1.0 and 50 wt. % glycerin.
Claim 20
Dependent Claim
18 words
The method of claim 15, wherein the drug-enhancer composition contains between about 5.0 and 20.0 wt. % glycerin.
Claim 21
Dependent Claim
36 words
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.
Claim 22
Dependent Claim
17 words
The method of claim 19 wherein the glycerin containing drug-enhancer composition is administered to an afflicted situs.
Claim 23
Dependent Claim
17 words
The method of claim 19 wherein the glycerin containing drug-enhancer composition is administered to an application situs.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1992-08-07 | 1993-02-06 | 1993-08-08 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1996-08-07 | 1997-02-06 | 1997-08-08 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2000-08-07 | 2001-02-06 | 2001-08-08 | $7700.00 | Window Closed / Lapsed |