Preparation of a novel floating ring capsule-type dosage form for stomach specific delivery

AbstractStudy objectives were to develop a unique floating ring capsule dosage form which combines gastric soluble and insoluble portions, and to evaluate its suitability for stomach specific drug delivery. New floating ring capsules were developed using different polymers and were compared for various parameters. The formulation with HPMC and sodium CMC has better floating properties. The effects of polymers concentration on drug release were studies by in vitro release studies. The interaction studies of combined drug with polymers were determined using FT-IR spectroscopy. The entrapped air within the gel barrier and lower densities of HPMC and sodium CMC resulted in better floating behavior. Steady slow gel formations showed prolonged drug release. The in vitro release rates were generally found to be faster with low concentration of carbopol showing release within 2h, while formulations containing high amount of HPMC showed release in 8h. In particular, the higher concentration of HPMC formulation shows the best drug release performance. A very low change in peak shift was observed only with sodium alginate formulations. Further, FT-IR measurements confirmed the absence of any chemical interactions. Results indicate that new floating ring capsule is a promise dosage form for stomach specific delivery

Development and validation of RP-HPLC method for determination of Atorvastatin calcium and Nicotinic acid in combined tablet dosage form

A simple, specific and accurate reverse phase liquid chromatographic method was developed for the simultaneous determination of Atorvastatin calcium and Nicotinic acid in tablet dosage forms. The analysis has been performed by using Agilent ZORBAX SB-C18 (150 × 4.6 mm, 3.5 u) and mobile phase containing acetonitrile: distilled water (85:15) at pH 4.5 (adjusted with phosphoric acid). The detection was carried out at 261 nm with a flow rate of 1.0 ml/min. The retention times of Atorvastatin calcium and Nicotinic acid were 6.092 and 3.125 min, respectively. The method was validated according to ICH guidelines. The method was validated for specificity, precision, linearity, accuracy and robustness. The linearity for Atorvastatin calcium and Nicotinic acid were in the range of 2–12 and 10–80 μg/ml respectively. The recoveries of Atorvastatin calcium and Nicotinic acid were found to be in the range of 99.031% and 99.744% respectively. The proposed method was validated and successfully applied to the estimation of Atorvastatin calcium and Nicotinic acid in combined tablet formulation