Abstract

STUDIES ON FORMULATION OF LANSOPRAZOLE DELAYED RELEASE CAPSULES USING EUDRAGIT L30 D55 AND OTHER POLYMERS

Dr. Ch. Saibabu*, Dr. K. Thejomoorthy and Shaik Mahaboob Basha

Abstract

Lansoprazole is an anti-Ulcer Agents, Antihistamines, Enzyme Inhibitors, proton pump inhibitor. Lansoprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that do not exhibit anticholinergic or histamine H2-receptor antagonist properties, but rather suppress gastric acid secretion by specific inhibition of the (H+,K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell. Lansoprazole delayed-release capsules contain an entericcoated granule formulation of Lansoprazole. Absorption of Lansoprazole begins only after the granules leave the stomach. Absorption is rapid, with mean peak plasma levels of Lansoprazole occurring after approximately 1.7 hours. Lansoprazole is available as a capsule, and is available in 15 mg and 30 mg strengths. It needs control in the dissolution rate in its formulation development to provide delayed therapeutic effect. In the present study Sugar spheres, corn starch, Hydroxy propyl cellulose, Sodium lauryl sulphate (SLS), Tri ethyl citrate (TEC) and in combination with Methacrylic acid copolymer type C and Polysorbate 80 were tried to control the delay in dissolution rate of glimepiride in its tablet formulation development. The objective of the study is to prepare delayed release formulation. There are seven formulations[1] employing selected combinations of the Methacrylic acid copolymer type C, Polysorbate 80 and in combination with Hydroxy propyl cellulose, Sodium lauryl sulphate (SLS), Tri ethyl citrate (TEC) were formulated. The tablets were prepared by Fluidized Bed processor (Wurster coater) and were evaluated. The physical parameters[2] of the Lansoprazole tablets evaluated during drug loading, sub coating, enteric coating stage and capsule filling stage found satisfactory in all the cases. Lansoprazole content of the tablets prepared was within 97±3%. Much variations were observed in the dissolution characteristics of the Lansoprazole tablets prepared. Dissolution rate of Lansoprazole tablets prepared was studied from all the tablets prepared followed first order kinetics with coefficient of determination (R2) values above 0.82. The first order dissolution rate constant (K1) values were estimated from the slope of the first order linear plots. Much variations were observed in the dissolution rate (K1) of the tablets prepared due to formulation variables. The K1 values indicated that the individual and combined effects of the dissolution rate of Lansoprazole tablets are highly significant (P < 0.01). Lansoprazole tablet formulations D5S3E6 gave delayed release of Lansoprazole others. These tablets (F9) shown 12 hours dissolution profile and found stabile in accelerated condition also.

Keywords: Lansoprazole tablets, Delayed release, Sugar spheres, corn starch, Hydroxy propyl cellulose, Sodium lauryl sulphate (SLS), Tri ethyl citrate (TEC), Methacrylic acid copolymer type C and Polysorbate 80.