A New Approach to Enhance the Solubility of Famotidine Tablet by Using Naturally Isolated Pear Starch.

Abstract

Purpose: The solubility of drug is affected by various excipients present in formulation. In case of tablet formulation, the role of binders is very important for solubility of dosage form as well as drug. In this study, an attempt was made to improve the solubility and dissolution rate of a drug by the use of natural excipients. In this study, pear was selected for the extraction and isolation of starch. Then the extracted starch was used as a binder in different concentrations, in famotidine tablets and evaluates them. There are some recent patents on modified starch (WO2011002730A1), directly compressed starch (US6455069B1), pre-compacted starches (US4072535A), which helped in following the study.

Methods: The starch was isolated from natural source. Then, the tablets were formulated by wet granulation method by using 2% w/v, 4% w/v, 6% w/v and 8% w/v of pear starch as binding agent. Then formulated famotidine tablets were further evaluated for various parameters i.e. weight variation, hardness, thickness, friability, disintegration time and in-vitro drug release.

Results: The hardness and disintegration time of the tablets was found to be increased with increase in starch concentration. Tablets with the highest binder concentration showed maximum hardness (6.5 kg) and disintegration time (10min) and minimum friability (0.48%). After one hour, tablets with 4% w/v starch showed maximum drug release (80.69%).

Conclusion: The pear fruit used for the isolation of starch was a natural and a newer source. The obtained starch was safe, natural, economic and easily isolated in laboratory. The results from various evaluations show that pear starch has significant binding characteristics. Hence it can be used as tablet binder in pharmaceutical formulations in future in place of other costly and synthetic starch.