Composition of dexibuprofen transdermal hydrogel
Stable non-alcoholic transdermal hydrogel of dexibuprofen was prepared by using a simple manufacturing process, and the experimental trials showed that the pH modifying agent, antioxidant and water miscible solvent are the essential excipients to obtain stable non-alcoholic transdermal hydrogel of dexibuprofen. The dexibuprofen hydrogel prepared using carbopol as a gelling polymer produced an opaque gel, whereas hydrogel prepared using hyroxypropyl methylcellulose (HPMC) as a gelling polymer produced a transparent gel. There was no significant changes observed with respect to physical description, pH, assay and particularly to the related substance values when the hydrogels were subjected to the stability study at accelerated condition (40° C./75% RH) for 3 months in laminated tubes.
1. A transdermal hydrogel composition consisting essentially of, by weight % of the composition,
1% to 15% dexibuprofen;
0.5% to 30% of a combination of three gelling agents wherein the first gelling agent is selected from one of HPMC K4M and hydroxy ethyl cellulose, the second gelling agent is HPMC E5, and the third gelling agent is poloxamer 188;
0.1% to 20% of a permeation enhancer consisting of diethylene glycol monoethyl ether;
sodium hydroxide;
0.05% to 5% of an antioxidant consisting of sodium metabisulfite;
two water miscible solvents consisting of polyethylene glycol and propylene glycol;
one or more preservative;
one or more soothing agent; and
water to total 100%.
2. The transdermal hydrogel composition according to claim 1 , wherein the one or more preservative consists of sodium benzoate, and the one or more soothing agent consists of menthol.
3. The transdermal hydrogel composition according to claim 1 , wherein the weight % of dexibuprofen is 10%.
4. The transdermal hydrogel composition according to claim 1 , wherein the weight % of dexibuprofen is 5%.