Abstract

DESIGN AND EVALUATION OF LEVETIRACETAM EXTENDED RELEASE PELLETS

Kumar Raja Jayavarapu*, Ramisetti Vijaybabu and R Anusha

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Abstract

The purpose of the present investigation was to prepare oral Pellets of levetiracetam with a view to reduce the frequency of dosing and to attain steady state drug levels in addition to masking the bitter taste and faint odor of drug. Levetiracetam is a second-generation antiepileptic agent useful in the treatment of partial onset and myoclonic seizures, which has short plasma half-life of 7 ± 1 hour in adults along with bitter taste and faint odor. Pelletization is one of the suitable drug delivery system for such drug candidate. Preformulation studies were carried out to rule out any drug-polymer interactions by FTIR technique, Pellets were prepared by using Extrusion- Spheronization process. and coating is carried out using FBD, Stability studies were carried out for the optimized formulation for a period of 90 days at 40 ±2 °C and 75 ± 5% relative humidity. mean particle size ranged from 989μm to 1011μm and percentage yield ranged from 93.34-98.12 % In the in vitro release studies initial burst release was observed from all the formulations. The most satisfactory formulation released drug for 24hours. SEM studies of the most satisfactory formulation showed that the pellets were spherical. The data obtained from in vitro release showed highest correlation with Higuchi model and the drug release was found to be Zero order.

Keywords: Levetiracetam, Pellets, FTIR, Extrusion- Spheronization, Release kinetics, SEM.