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Research Article Open Access
The potential gastrointestinal disorders associated with oral administration of Rofecoxib can be avoided by delivering the drug to the inflammation site at a sustained, concentrated level over an extended period of time. The present research has been undertaken with the aim to develop a transdermal gel formulation of Rofecoxib, which would attenuate the gastrointestinal related toxicities associated with oral administration. Starches form an important class of gel forming material of natural origin obtained from various sources like potato, corn, maize, wheat, rice etc. Various batches of Hydrotrope-gelled potato starch were prepared using 32 factorial designs. Potato starch along with hydrotropic salts like sodium salicylate and sodium benzoate were used. The formulations were evaluated for various parameters such as physical appearance, homogencity, PH, drug content uniformity, and rheological properties. In- vitro drug release of Rofecoxib from the formulations was studied using Keshary-Chein type diffusion cell. It was observed that hydrotropic salt sodium salicylate induced better gelling than sodium benzoate. Higher concentration of salts yielded more viscous gels. The gels prepared using sodium benzoate showed higher viscosity. In-vitro release data indicated that hydrotrope-gelled starch containing 1% Rofecoxib in formulation containing 15%w/w sodium salicylate and 5%w/w potato starch (W7SPD) with a percent average release of 16.65% in 6 hrs while formulation containing 15%w/w sodium salicylate and 10%w/w potato starch (W8SPD) showed a release of 16.39% in 6hrs. These formulations showed much higher release when compared to some marketed formulations whose percent release were between the ranges of 15.81% to 4.77% in 6hrs.
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Author(s): Sayyed Nazim MHG Dehghan Siraj Shaikh and Afsar Shaikh
Potato Starch, Gel, Spreatability, Rofecoxib, Keshary-Chein type diffusion cell