Abstract

Preethi Fernandiz, Suresh N.*, Kerryn Joseph A. D. Silva and S. Srinivasan

ABSTRACT

Background: The oral route of administration is considered as the most widely accepted route. The unique environment of the oral cavity offers its potential as a site for drug delivery. Aim & Objective: The objective of the current study was to develop and optimize a sublingual tablet of Rabeprazole sodium which is an effective drug in the treatment of peptic ulcer such as duodenal and gastric ulcer. Methods: The tablets were prepared by direct compression method using different superdisintegrating agents such as crospovidone, sodium starch glycolate, kyrone T-314. The compatibility studies of drug and excipients were performed by FTIR spectroscopy. After examining the flow properties of the powder blends the results are found to be within prescribed limits and indicated good flowing property, it was subjected to tablet compression. Results: The tablets were evaluated for post compression parameters like weight variation, hardness, thickness, friability, drug content uniformity, wetting time, and disintegration time, in-vitro dissolution study. An optimized tablet formulation i.e. F9 was found which provided short wetting time of 28 sec, in-vitro disintegration time of 29sec which facilitates its faster disintegration and higher the drug content of 98.99%, the best in-vitro drug release was found to be in formulation F9 i.e. 94.01% during the end of 14min. From the above results, it indicate that formulation F9 containing equal ratio of different super disintegrating agents (1:1:1) emerged as the overall best formulation based on drug release characteristics with phosphate buffer pH 6.8 as dissolution medium. Stability studies were carried out which indicate that selected formulation (F7, F8, F9) was stable. Conclusion: Sublingual tablets of Rabeprazole sodium were prepared using different superdisintegrants, such as kyrone T-314, sodium starch glycolate and crospovidone by direct compression method. A total of eleven formulations were prepared.