Design and In vitro Evaluation of a Novel Sustained Release Double Layered Tablets of Lornoxicam by using semi synthetic polymers

Abstract:

The objective of the present study was to develop double layered tablets of lornoxicam, a highly potent nonsteroidal anti-inflammatory drug. Double layered tablets compris 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. Double layered tablets 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 lornoxicam with β-cyclodextrin at 1:2 (drug: β-CD) molar ratio, was incorporated in the fast release layer to increase the release rate of lornoxicam 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, F2 was selected as the best formulation as it fulfilled all the criteria. The drug release of F2 extended up to 12 h period. Based on the statistical analysis the drug release follows Anomalous diffusion mechanism. Two months of short term stability study were carried out at 30 ± 2°C / 65 ± 5% RH and 40 ± 2°C / 75 ± 5% RH for the best selected formulation. The results showed that there were no significant changes in all the parameters evaluated for the best formulation.

Key words: β–cyclodextrin, Double layered tablets, Lornoxicam, NSAID's, Sustained release.