Abstract

DESIGN AND IN VITRO EVALUATION OF A NOVEL SUSTAINED RELEASE DOUBLE LAYER TABLETS OF KETOPROFEN

K. Borah*, G. Boruah and Dr. S. Kalyanappa

ABSTRACT

The objective of the present study was to develop double layered tablets (DLTs) of ketoprofen, a highly potent non steroidal anti-inflammatory drug. DLTs is comprising of fast release layer and a sustained release layer, anticipating the rapid drug release that starts in the stomach rapidly alleviate the symptoms and continuous in the intestine to maintain the prolonged analgesic effect. DLT‟s are characterized by initial drug release in the stomach and comply the requirements of sustained release portion of the dosage form. An inclusion complex of ketoprofen with β-cyclodextrin at 1:1 (drug:β- CD) molar ratio, was incorporated in the fast release layer to increase the release rate of ketoprofen in the stomach to produce rapid analgesic effect. Hydroxy propyl methyl cellulose (HPMC), a hydrophilic matrix forming agent, was integrated in the sustained release layer to provide the sustainment of drug release, F-2 was selected as the best formulation as it fulfilled all the criteria. The drug release of F-2 found to be 96.70%. Based on the statistical analysis the drug release follows Anomalous diffusion mechanism. Two months of stability study were carried out at 30 ± 2°C / 65 ± 5 % RH for the best selected formulation. After stability studies the percentage cumulative drug release was found to be 96.22% and 95.67% at 30th and 60th days of stability. The results showed that there were no significant changes in all the parameters evaluated for the best formulation. FTIR (ATR) and DSC study have shown that there is no drug and polymer interaction.

Keywords: ketoprofen; ? – cyclodextrin; double layered tablets; sustained release.