Formulation and Evaluation of Enteric Coated SustainRelease Tablets of Lansoprazole in a ò-CyclodextrinComplex to Improve the Photostability

Abstract

Enteric coated sustain release Lansoprazoletablets which are proton pump inhibitors in action, are widely used in the treatment of gastric ulcers. The aim of the present study is to improve photostabilityof Lansoprazole. Enteric Coated sustain release tablets of Lansoprazolewere formulates by using enteric polymers like Kollicoat MAE 30DP, and Eudragit L 100. Primary characterization of the drug was done by performing the melting point, identification test by Fourier Transform Infrared Spectroscopy, solubility and assay. To understand the compatibility of the drug with excipients, drug-excipient studies were carried out using Infrared spectroscopy. Using complexation technique different ratios of the drug were complexed with cyclodextrin to improve photostability. The stability test results indicated that the inclusion complex was more stable than raw Lansoprazole in the light. It was observed that inclusion complex of Lansoprazole showed increased the solubility by about 4.5 times. There were no significant differences between 30 min, 6 h and 24 h for either raw material or inclusion complex. Among the four polymers chitosan, xanthum gum, locust bean gum, and guar gum as polymers, chitosan was chosen for further coating process. Physico-chemical and in-vitro drug release studies were performed to all the formulations. F4c formulation was found to be best formulation which showed better resistance in 0.1N HCL, sustained well and with in-vitro release of97.83± 0.39% release in 12hrs.