Mohammad Gulzar Ahmed

Self-emulsifying drug delivery system (SEDDS) is an isotropic mixture of drug, oil, surfactant and co-surfactant which spontaneously forms emulsion in aqueous environment under gentle agitation. Many drugs are lipophilic in nature making them difficult for oral delivery as the GI environment is aqueous in nature. The objective of present work was to develop and evaluate the SEDDS of Aceclofenac using oleic acid as oil, tween 20 as surfactant and PEG 400 as  co-surfactant. Compatibility studies showed no interaction between drug and excipients used. Ternary phase diagram was constructed to optimize the formulation. Formulated SEDDSs were evaluated for drug content, zeta-potential, robustness to dilution, globule size and in-vitro drug release. Globule size were between 151.1-182.3 nm and spherical in shape. In-vitro drug release study revealed that the drug release form the formulated SEDDSs were faster when compare to pure drug and marketed product. Formulation S6 showed the highest drug release i.e. 91.71% within 25 m. Formulations were stable during testing period of 3 months. From this work, it was cleared that the SEDDS of Aceclofenac was found to be significant in terms of releasing of the drug as compare to pure drug and marketed product.

In order to achieve rapid action and sustained release, we have fabricated dual type of mini-tablets of Diclofenac Sodium enclosed in a single capsule. 10 formulations of rapid release (IF1-10) mini tablets were prepared using sodium starch glycolate, Cross povidone and Micro crystalline cellulose. 12 formulations of sustained release (SF1-12) mini tablets were prepared by using HPMC, carbopol, Ethyl cellulose, xanthan gum and guar gum. All formulations were evaluated for pre-compression and post-compression parameters. Drug Excipient interaction was determined by FTIR, Short term stability studies were carried out at 40 0C /75 % RH for 3 months. Pre-formulation and studies conformed that all formulations showed better flow property. In vitro studies showed that all mini tablets in combination released more than 55 % within 30 min whereas marketed tablet Voveran SR 100 showed only 11 % release indicating the rapid drug release and the release was extended up to 80 % in 20th hour indicating the sustainability of the release. Natural polymers, Xanthan gum and guar gum containing formulations showed above 90 % in 12th hour indicating little rapid drug release when compared to synthetic polymers. FTIR report indicated no interaction of drug with excipients. Stability studies showed no significant loss in drug content, release profile and physical appearance. Hence it can be concluded that, the release profiles duel type mini tablets were quite promising for once a day formulation.