Abstract

FORMULATION AND DEVELOPMENT OF LEVETIRACETAM FILM-COATED TABLETS AND IT'S COMPARATIVE EVALUATION OF PHYSICAL AND CHEMICAL PARAMETERS BETWEEN ACCELERATED AND REAL TIME STABILITY

Vijay Kumar Panthi*

Abstract

Levetiracetam is an antiepileptic drug with favourable pharmacologic characteristics and demonstrated activity in improving seizure control. Core part of tablet is prepared by wet granulation method. After final formulation the tablet is coated by both seal and film coating method with Hydroxy Propyl Methyl Cellulose 5 cps and packed in alu-alu strips, finally placed in Accelerated and Real time stability by maintaining 75%±5% humidity & 40ºC±2ºC temperature and 65±5% humidity & 30º±2ºC temperature respectively and periodically followed up to three months for comparative observation of physical and chemical parameters of levetiracetam tablets. As per stability data it is concluded that the product is appeared effective in case of both physically and chemically in a accelerated and real time stability chamber but Real time stability sample is considered more stable than Accelerated in case of physical parameters because hardness and disintegration time is increased higher rate in accelerated as compared to real time. Similarly, Assay% is also observed more good in real time than accelerated which is considered that levetiracetam tablet is chemically more stable in real time stability than accelerated but there is no significant difference in drug release between these two stability chamber because they both are appeared equally release in Accelerated and Real time analysis. Hence, it has finally concluded that levetiracetam tablet is found more stable in Real time stability than Accelerated in case of both physically and chemically but in case of drug release, it is observed that two stability chamber showed the product equally stable.

Keywords: Levetiracetam, Physical Parameters, Chemical Parameters, Accelerated stability, Real Time Stability