US2022387301A1PendingUtilityA1

Transdermal compositions of ibuprofen and methods of use thereof

78
Assignee: APONIA LABORATORIES INCPriority: May 3, 2011Filed: Aug 8, 2022Published: Dec 8, 2022
Est. expiryMay 3, 2031(~4.8 yrs left)· nominal 20-yr term from priority
Inventors:Haigang ChenGareth WinckleChristopher Riley
A61K 47/20A61K 47/14A61K 47/10A61K 47/38A61K 47/18A61K 9/06A61K 47/22A61P 29/00A61K 9/0014A61K 47/12A61K 9/127A61K 31/192A61K 2121/00A61P 21/02A61P 19/02
78
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Claims

Abstract

A transdermal composition comprising ibuprofen or salts thereof and a gelling agent which can be used for the treatment of such disorders as pain, inflammation, arthritis, muscle spasm and associated symptoms in humans and animals.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A composition for transdermal administration of ibuprofen or salts thereof comprising:
 ibuprofen in an amount between about 1% and about 30% by weight of the composition;   a gelling agent; and   a non-volatile solvent.   
     
     
         2 . The composition of  claim 1 , wherein the ibuprofen is S(+)-ibuprofen. 
     
     
         3 . The composition of  claim 1 , wherein the ibuprofen is in an amount between about 5% and about 15% by weight of the composition. 
     
     
         4 . The composition of  claim 1 , wherein the ibuprofen is in an amount between about 8% and about 11% by weight of the composition. 
     
     
         5 . The composition of  claim 1 , wherein the gelling agent is selected from the group consisting of methyl cellulose, ethyl cellulose, hydroxycellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, and mixtures thereof. 
     
     
         6 . The composition of  claim 1 , wherein the gelling agent comprises hydroxypropyl cellulose. 
     
     
         7 . The composition of  claim 1 , wherein the gelling agent is in an amount between about 0.1% and about 10% by weight of the composition. 
     
     
         8 . The composition of  claim 1 , wherein gelling agent is in an amount between about 1% and about 5% by weight of the composition. 
     
     
         9 . The composition of  claim 1 , wherein the non-volatile solvent is dimethyl sulfoxide (DMSO). 
     
     
         10 . The composition of  claim 1 , wherein the non-volatile solvent is N-methyl pyrrolidone. 
     
     
         11 . The composition of  claim 1 , wherein the non-volatile solvent is in an amount between about 30% and about 55% by weight of the composition. 
     
     
         12 . The composition of  claim 1 , wherein the composition further comprises a lower alkyl alcohol. 
     
     
         13 . The composition of  claim 12 , wherein the lower alkyl alcohol is selected from the group consisting of ethanol, propanol, isopropyl alcohol, and mixtures thereof. 
     
     
         14 . The composition of  claim 12 , wherein the lower alkyl alcohol is isopropyl alcohol. 
     
     
         15 . The composition of  claim 12 , wherein the lower alkyl alcohol is in an amount between about 25% and about 70% by weight of the composition. 
     
     
         16 . The composition of  claim 12 , wherein the lower alkyl alcohol is in an amount between about 35% and about 40% by weight of the composition. 
     
     
         17 . The composition of  claim 1 , wherein the composition further comprises a skin penetration enhancer. 
     
     
         18 . The composition of  claim 17 , wherein the skin penetration enhancer comprises oleic acid. 
     
     
         19 . The composition of  claim 17 , wherein the skin penetration enhancer is in an amount between about 0.1% and about 25% by weight of the composition. 
     
     
         20 . The composition of  claim 17 , wherein the skin penetration enhancer is in an amount between about 1% and about 5% by weight of the composition. 
     
     
         21 . The composition of  claim 1 , wherein the composition is an anhydrous gel. 
     
     
         22 . The composition of  claim 1 , wherein the viscosity of the composition is between about 40,000 cps and about 400,000 cps. 
     
     
         23 . The composition of  claim 1 , wherein the viscosity of the composition is between about 100,000 cps and about 300,000 cps. 
     
     
         24 . The composition of  claim 1 , wherein the viscosity of the composition is between about 150,000 cps and about 250,000 cps. 
     
     
         25 . A composition for transdermal administration of ibuprofen, the composition comprising:
 ibuprofen in an amount between about 1% and about 30% by weight of the composition;   a gelling agent;   a lower alkyl glycol; and   a lower alkyl alcohol in an amount between about 30% and about 55% by weight of the composition;   wherein the composition has a viscosity of between 10,000 cps and 100,000 cps.   
     
     
         26 . The composition of  claim 25 , wherein the ibuprofen is S(+)-ibuprofen. 
     
     
         27 . The composition of  claim 25 , wherein the ibuprofen is in an amount between about 5% and about 15% by weight of the composition. 
     
     
         28 . The composition of  claim 25 , wherein the ibuprofen is in an amount between about 8% and about 11% by weight of the composition. 
     
     
         29 . The composition of  claim 25 , wherein the gelling agent is selected from the group consisting of methyl cellulose, ethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, and mixtures thereof. 
     
     
         30 . The composition of  claim 25 , wherein the gelling agent comprises hydroxypropyl cellulose. 
     
     
         31 . The composition of  claim 25 , wherein the gelling agent is in an amount between about 0.1% and about 10% by weight of the composition. 
     
     
         32 . The composition of  claim 25 , wherein gelling agent is in an amount between about 1% and about 5% by weight of the composition. 
     
     
         33 . The composition of  claim 25 , wherein the lower alkyl glycol is selected from the group consisting of propylene glycol, polymethylene glycol, polyethylene glycol, and mixtures thereof. 
     
     
         34 . The composition of  claim 25 , wherein the lower alkyl glycol comprises propylene glycol. 
     
     
         35 . The composition of  claim 25 , wherein the lower alkyl glycol is in an amount between about 1% and about 40% by weight of the composition. 
     
     
         36 . The composition of  claim 25 , wherein the lower alkyl glycol is in an amount between about 5% and about 25% by weight of the composition. 
     
     
         37 . The composition of  claim 25 , wherein the lower alkyl alcohol is selected from the group consisting of ethanol, propanol, isopropyl alcohol, and mixtures thereof. 
     
     
         38 . The composition of  claim 25 , wherein the lower alkyl alcohol comprises isopropyl alcohol. 
     
     
         39 . The composition of  claim 25 , wherein the lower alkyl alcohol is in an amount between about 25% and about 70% by weight of the composition. 
     
     
         40 . The composition of  claim 25 , wherein the lower alkyl glycol is in an amount between about 60% and about 70% by weight of the composition. 
     
     
         41 . The composition of  claim 25 , wherein the composition is a gel. 
     
     
         42 . The composition of  claim 25 , wherein the composition is anhydrous. 
     
     
         43 . The composition of  claim 25 , wherein the composition comprises water. 
     
     
         44 . The composition of  claim 43 , wherein the water is in an amount between about 0.1% and about 30% by weight of the composition. 
     
     
         45 . The composition of  claim 43 , wherein the composition has a pH of between 4.0 to 5.0. 
     
     
         46 . The composition of  claim 25 , wherein the composition further comprises a skin penetration enhancer. 
     
     
         47 . The composition of  claim 46 , wherein the skin penetration enhancer is in an amount between about 0.1% and about 30% by weight of the composition. 
     
     
         48 . The composition of  claim 46 , wherein the skin penetration enhancer comprises isopropyl myristate. 
     
     
         49 . The composition of  claim 46 , wherein the skin penetration enhancer comprises Transcutol P. 
     
     
         50 . The composition of  claim 46 , wherein the skin penetration enhancer comprises Tween 20. 
     
     
         51 . The composition of  claim 46 , wherein the skin penetration enhancer comprises benzyl alcohol. 
     
     
         52 . The composition of  claim 46 , wherein the skin penetration n enhancer is in an amount between about 0.1% and about 30% by weight of the composition. 
     
     
         53 . The composition of  claim 46 , wherein the skin penetration enhancer is in an amount between about 1% and about 10% by weight of the composition. 
     
     
         54 . The composition of  claim 25 , wherein the composition further comprises a base. 
     
     
         55 . The composition of  claim 54 , wherein the base is selected from a group consisting of a primary amine, a secondary amine, and a tertiary amine. 
     
     
         56 . The composition of  claim 54 , wherein the base is triethanolamine. 
     
     
         57 . The composition of  claim 25 , wherein the viscosity of the composition is between about 5,000 cps and about 100,000 cps. 
     
     
         58 . The composition of  claim 25 , wherein the viscosity of the composition is 10,000 cps and about 50,000 cps. 
     
     
         59 . The composition of  claim 25 , wherein the viscosity of the composition is between about 15,000 cps and about 35,000 cps. 
     
     
         60 . A method of reducing pain or inflammation comprising:
 administering to a dermal surface of a subject in need of a reduction in pain or inflammation a topical composition of any of  claim 1  or  25 .   
     
     
         61 . The method of  claim 60 , wherein the dermal surface is on the neck. 
     
     
         62 . The method of  claim 60 , wherein the dermal surface is on the back. 
     
     
         63 . The method of  claim 60 , wherein the dermal surface is on an arm. 
     
     
         64 . The method of  claim 60 , wherein the dermal surface is on a hand. 
     
     
         65 . The method of  claim 60 , wherein the dermal surface is on a foot. 
     
     
         66 . The method of  claim 60 , wherein the dermal surface is on a leg. 
     
     
         67 . The method of  claim 60 , wherein the dermal surface is on a joint.

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