Abstract

FORMULATION DEVELOPMENT AND INVITRO EVALUATION OF RAPIMELTS CONTAINING MUCOLYTIC AGENT

Vijaya Sai Lakshmi, Shanmuganathan S. and Gopinath S.

ABSTRACT

In the present study, rapimelts of bromhexine hydrochloride was prepared by using various ratios of synthetic superdisingrants such as sodium starch glycolate and croscaramellose sodium and natural superdisintegrant such as Plantago ovata mucilage by direct compression technique. Totally nine formulations were prepared. The powder blend of all the formulations were subjected to various pre compression parameters such as angle of repose, bulk density, tapped density and compressibility index before their compression into tablets. The findings of all the pre compression parameters were within the prescribed limits. The prepared rapimelts were subjected to various post compression parameters such as weight variation, hardness, friability, wetting time, water absorption time and disintegration time. The findings of all the post compression parameters were within the prescribed limits. From all the nine formulations, rapimelts prepared with natural super disintegrant show higher percent drug release than synthetic super disintegrant. Among the three formulations of natural superdisintegrant, the formulation P-III shows higher percent of drug release than the P-I & P-II, due to the increased concentration of natural super disintegrant which leads to decreasing the disintegration time and increasing the dissolution time of drug. Based on the lower disintegration time and higher percent of drug release, the formulation P-III was subjected to accelerated stability study as per ICH guidelines at 40ºC ±2ºC/75% RH ±5% for three months. The tablets were tested at different time interval (30, 60 and 90 days) for percentage of drug release and it was observed that no remarkable changes were found in the percentage of drug release from P-III after the stability study. Hence the formulation P-III is considered as more stable formulation.

Keywords: Rapimelts, Bromhexine hydrochloride, Plantago ovata mucilage, direct compression, sodium starch glycolate and croscaramellose sodium.