FORMULATION AND EVALUATION OF LANSOPROZOLE DELAY RELEASE PELLETS

Ch. Saibabu*, K. Harikrishna, S. K. Karishma, G. Praveen Kumar, N. Yajjari and Y. Sri Sruthi

ABSTRACT

The work was carried out to delay the release of Lansoprazole by using enteric polymer Methacrylic acid copolymer (type C). The study includes preformulation of drug and excipients, formulation and evaluation, release kinetics and stability studies of capsules. Drug Loading was given to sugarsheres by using different binders i.e., Klucel- LF and L- HPC with different concentrations. The amount of drug bound to sugarsheres increases with an increased concentration of HPC(L-type) (17.5% and 22%). But at high concentration of HPC (22%), lumps were observed. Finally, 17.5% w/w HPC was optimized as binder for drug coating. Sub coating was given to drug loaded pellets to avoid direct contact with enteric coating. Sub coating was given with HPC and Corn starch combination at an average weight build-up of 6.1% w/w of sub coated pellets. Enteric coating was given to Lansoprazole pellets by Methacrylic acid copolymer type C (30% aqueous dispersion). Enteric coating was optimized at an average weight build-up of 53% w/w of enteric coated pellets and release profile was compared with Innovator. In enteric coating, plasticizer plays major role in film formation of pellets. Among TEC and PEG 6000, TEC was found to have good film forming capacity. Plasticizer concentration was optimized at 20% of dry polymer weight. Enteric coated pellets were evaluated for assay, acid resistance and dissolution; E6 enteric coated pellets were found to be optimized and were filled into capsules. These capsules were evaluated and the results were found to be more similar with innovator. Different kinetic models were applied to optimized enteric coated formulation (E6) and observed that it follows zero order kinetics with Higuchi diffusion mechanism. Stability studies were conducted at 40ºC / 75% RH (accelerated stability testing) for 3 months. Assay, acid resistance, dissolution release profile of optimized enteric coated formulation (E6) complies with Innovator and was found to be stable.

Keywords: Lansoprazole, Preformulation, enteric coating, delay released pellets.