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 non-alcoholic transdermal hydrogel of dexibuprofen.
2 . The non-alcoholic transdermal hydrogel of dexibuprofen of claim 1 , wherein said hydrogel is transparent.
3 . A non-alcoholic transdermal hydrogel of dexibuprofen essentially comprising of one or more pH modifying agent, antioxidant and water miscible solvent.
4 . A non-alcoholic transdermal hydrogel of dexibuprofen according to claim 3 , further comprising of one or more of surfactant, antifoaming agent, chelating agent, gelling polymer, preservative, permeation enhancer, soothing agent, and flavoring agent.
5 . A non-alcoholic transdermal hydrogel of dexibuprofen according to claim 4 , wherein one or more gelling agent may be selected from the group comprising of carbomer, hydroxypropyl methylcellulose (HPMC), hydroxyethyl cellulose (HEC), hydroxypropyl cellulose (HPC), methylcellulose (MC), poloxamer, sodium alginate, carrageenans, tragacanth, pectin, guar gum, xanthan gum, gellan gum and polyacrylamid.
6 . A non-alcoholic transdermal hydrogel of dexibuprofen according to claim 3 , wherein one or more water miscible solvent may be selected from the group comprising of polyethylene glycol, propylene glycol, and glycerin.
7 . A non-alcoholic transdermal hydrogel of dexibuprofen according to claim 3 , wherein one or more pH modifying agent may be selected from the group comprising of sodium hydroxide, citric acid, sodium citrate, triethanolamine, and diethanolamine.
8 . A non-alcoholic transdermal hydrogel of dexibuprofen according to claim 3 , wherein one or more antioxidant may be selected from the group comprising of sodium benzoate, sodium metabisulfite, butylated hydroxytoluene (BHT), and butylated hydroxanisole (BHA).
9 . A non-alcoholic transdermal hydrogel of dexibuprofen according to claim 3 , wherein asid hydrogel is transparent or translucent or opaque in nature.