Abstract

EFFECT OF MANNITOL AND MCC ON RAPIDLY DISINTEGRATING TABLETS

Bhargav R. Harkare*, Ajit S. Kulkarni, Nagesh H. Aloorkar, Shivprasad H. Majumdar.

Abstract

The main intention of this research was to develop rapidly disintegrating tablets of Amlodipine besylate for quick action. These tablets rapidly disintegrate in mouth in less than a minute, so no need to swallow whole tablet and no need of water to take it. Tablets were prepared by direct compression technique by using three different superdisintegrants, i.e. Crosspovidone, Sodium starch glycolate and Croscarmellose sodium. The prepared tablets were evaluated for thickness, hardness, weight variation, friability, drug content, In-vitro Disintegration time, wetting time and water absorption ratio and In vitro Dissolution studies. The hardness of all the formulation batch tablets was ranged from 2.4±0.10 kg/cm2 to 4.2±0.15 kg/cm2 and friability of all formulations was less than 1%, weight variation and drug content were within official limit.In-vitro disintegration time and in-vitro drug release shows that among all the superdisintegrants used Croscarmellose sodium gives the least in-vitro disintegration time and release the maximum amount of drug. The results show that an increase in Croscarmellose sodium concentration leads to a decreases in the in-vitro disintegration time and thus increase in the in-vitro drug release. Thus formulation F11 was selected as best formulation among those examined. Formulation F11 was then studied for accelerated stability studies as per ICH guidelines for 30 days that shows no significant change in the formulation. Therefore no evidence of degradation of drug was observed.

Keywords: Rapidly Disintegrating Tablets, Crosspovidone, Sodium starch glycolate, Croscarmellose sodium.