Mr. Shah Akashkumar Nareshkumar
PG Research Scholar, Department of Pharmaceutics, Sharda School of Pharmacy, Pethapur, Gandhinagar, Gujarat
Mr. Anil G. Raval
Assistant Professor, Department of Pharmaceutics, Sharda School of Pharmacy, Pethapur, Gandhinagar, Gujarat
Abstract
Aim: The aim of this study was to Formulation and Evaluation of colon targeted pellets of Bumadizone Calcium
Objective: Bumadizone Calcium is an acetic acid derivative, having irritation in stomach. Bumadizone Calcium has short half-life (4hrs) and undergoes first pass metabolism. It is pH-dependent. This research work was carried out to improve the bioavailability, patient compliance on oral colon targeted drug delivery. Bumadizone Calcium sustained release enteric coated pellets were prepared, which minimize the release of drug in stomach for treatment of IBD formulated by Extrusion Spheronization process.
Experimental work done: Enteric coated pellets prepared by Extrusion Spheronization technique. Eudragit S100, HPMC, PVP K30, and Ethyl Cellulose were used as rate controlling polymers. In this study, a pH dependent colon targeted enteric coated pellets was established using 32 full factorial design by giving enteric coating with Eudragit S100. Different Concentration of Eudragit S100 as an enteric coating material (4%, 5%, & %6) and PVP K30 as a Binder (0.5%, 1% & 1.5%) are taken for the measurements of % Drug Release that are performed by using USP dissolution 1 (Basket type) at 50 rpm. The test is performed with gastric fluid (pH 1.2) at 37±0.5 for first 2 hours & then in phosphate buffer 6.8 for 4 hrs & finally in phosphate buffer pH 7.4 for 6 hrs. The prepared formulations were evaluated for drug-excipient compatibility study, flow property, drug content, and coating process efficiency.
Results and Discussion: Optimized batch shown that less than 0.50% of the drug released at the end of 2 hrs in pH 1.2, less than 20% of drug released after end of 4 hrs in pH 6.8 and more than 85% at the end of 12 hrs in pH 7.4.
Conclusion: Bumadizone Calcium Enteric Coated pellets can be successfully formulated by addition of PVP K-30 as a binder and Eudragit S100 as Coating polymer. It was also concluded that prepared formulation minimizes drug release in stomach and avoid side effect of the drug.
Keywords: Bumadizone calcium, Eudragit S100, Enteric coating, extrusion spheronization technique, 32 full factorial designs.