FORMULATION DEVELOPMENT AND EVALUATION OFSUSTAINED RELEASE OXCARBAZEPINE TABLET

Abstract

The Sustained release drug delivery systems that are designed to achieve or extend therapeutic effect by continuously releasing medication over an extended period of time after administration of a single dose, to individualize treatment more effectively. Oxcarbazepine indicated as monotherapy or adjunctive therapy for the treatment of partial seizures with or without secondarily generalized tonic-clonic seizures in adults and children. The polymer hydroxy propyl methyl cellulose (HPMC) was selected. The other excipients were used are magnesium stearate used as lubricant, Polyvinylpyrrolidone used as binder of tablet, and cross carmellose sodium as super disintegration agent. Oxcarbazepine was prepared by wet granulation technique.

FTIR was done to show there was no drug interaction with formulation additive to tablet.

The pre-compression study indicated the excellent flow properties of bulk powder which is within acceptable range according to pharmacopeia specifications.

The post-compression parameters results match the expected criteria specifications.

 The Cumulative %Drug release of formulation F9 showed the highest release 98.34%. Formulation F1, F2, F3, F4,F5,F6,F7,F8 showed 68.35,78.33,88.77,85.39,88.46,90.46,92.88 & 89.65 in 12 hours.The stability study of the prepared tablets were carried out according to ICH guidelines at    2±2⁰C, 25±2⁰C/60±5% RH, 30±2⁰C/65±5% RH, 40±2⁰C/75±5% RH, 55±2⁰C for one month  by storing the samples in  stability chamber.

Key Words: Oxcarbazepine, Hydroxy Propyl Methyl Cellulose, MagnesiumStearate, Cross Carmellose Sodium.