FORMULATION AND EVALUATION OF LANSOPRAZOLE AND DOMPERIDONE MOUTH DISSOLVING TABLETSAbstract
Lansoprazole and Domperidone, used as Proton pump inhibitor and antiemetic agents, especially for disease related to gastric ulcer. The purpose of the research was to improve aqueous solubility of drugs by β-CD using a different method, and perform phase solubility study of both drugs using β-CD and calculate Ks, and ∆Gt. Prepare Complex of LAN and DOM with β-CD using different methods like physical mixture, kneading and co evaporation. Complexes were evaluated for drug content. Based on characterization and dissolution study, kneading method based complex was optimized and tablet prepared using different superdisintegrants like Sodium Starch Glycolate, Cross Povidone, Cross Carmellose Sodium as a synthetic super disintegrating agent and Isphagula, Banana powder and Mango powder as a natural super disintegrating agent. Prepared tablets were evaluated for pre-compression and post-compression parameters such as hardness, friability, disintegration time, wetting time, dissolution study and accelerated stability study. Prepared tablets loaded with complex were compared with a marketed tablet for dissolution study. Optimized complex molar ratios for both drugs were 3:1 and have acceptable data for dissolution enhancement, and the optimized method was kneading method. F3 batch of tablets shows only 25 sec of disintegration time and 96.16 and 93.14% for Lansoprazole and Domperidone drug release within 6 min. Pass accelerated stability testing also better than its available marketed tablets (marketed tablet had 32% drug release within 30 min. and 55 sec disintegration time). Aqueous solubility of both drugs successfully improved by β-CD and achieve a rapid onset of action of drugs by preparing mouth dissolving tablets.
S. G. Rathi *, D. J. Patel, S. K. Shah and B. Y. Joshi
Department of Pharmaceutics, Saraswati Institute of Pharmaceutical Sciences, Dhanap, Gandhinagar, Gujarat, India.
21 December 2019
23 January 2020
14 March 2020
01 December 2020