Abstract

FORMULATION AND OPTIMIZATION OF ANTIEPILEPTIC DRUG (CLOBAZAM) FAST DRUG DELIVERY SYSTEM

Abhishek Mishra*, Deepshi Srivastava, Mohd Lateef Khan and Suraj Mishra Ramnivas

ABSTRACT

The objective of present study was to formulate and evaluate taste masked fast dissolving tablets of Clobazam to increase the palatability and bioavailability of the drug. Clobazam is a newer 1,5-benzodiazepine used for the treatment of epilepsy. It is better tolerated and less sedating than other benzodiazepines. Absorption of the drug can be impacted by oral fast dissolving dosage form; this may have implications for epilepsy in paediatrics and those having difficulty in swallowing tablets/capsules resulting in improved patient compliance. The purpose of the present investigation was to formulate and optimize clobazam Oro-dissolving tablets by direct compression method using response surface methodology (RSM). Taste improvement of drug with HP-β-Cyclodextrin was done by simple complexation approach using physical and kneading methods. Taste perception study was carried and the best taste masked ratio of 1:2 of kneading mixture (KF4) was selected based on bitterness score and characterised by FTIR to identify the compatibility between drug and carrier. Prepared Tablets were evaluated for different properties like drug content, hardness, friability, disintegration time and In-vitro dissolution study. Different formulations showed disintegration time in the range of 20 to 75 second. Among all formulations, FLY3 showed 99% drug release within 10min. Thus, FLY3 was considered as the best among the prepared formulations, to which stability studies were conducted. The stability data confirmed the selected FLY3 tablets are stable as one not shown any changes in the results of different parameters before and after storage at 400C ±20 C/75% ± 5% RH for 3 months in stability chamber.

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