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.

Quality by Design Approach for Optimization and Development of Orodispersible Films of Lornoxicam Inclusion Complexes

“…The results were obtained as 0.21±0.03, 0.46±0.06 and 0.53±0.04 mg/mL respectively for the complexes at the drug to CD ratios of 2:1, 1:1 and 1:2. The solubility of pure drug was found to be 0.041±0.007 mg/mL which was correlated with that reported by Kalyanappa S et al [2]. Hence, the solubility of Lornoxicam was significantly improved and further, the complexes at the ratio of 1:2 were found to have maximum solubility.…”

“…It inhibits the cyclooxygenase enzymes, which helps to reduce the risk of adverse gastrointestinal (GI) effects seen in most of the non-steroidal anti-inflammatory drugs (NSAIDs). The water solubility of Lornoxicam is 0.0437mg/mL belonging to biopharmaceutical class II drugs [2], having a poor water-solubility and high permeation and hence possesses dissolution limited bioavailability. In order to overcome this problem, Lornoxicam should be developed into a dosage form such that its dissolution is enhanced.…”

Formulation and Evaluation of Fast Dissolving Film of Lornoxicam

“…5 ml sample was withdrawn at 1, 2, 3, 4, 5, 10, 15, 20, and 30 min intervals, and the same quantity was replaced with phosphate buffer of pH 6.8. The percentage of drug released was determined using UV visible spectrophotometer at 376 nm [16,17].…”

Solubility Enhancement of Embelin by Complexation with Beta Cyclodextrin

“…22 Layered tablets based on CDs has been developed for nonsteroidal anti-inflammatory drugs. 23 CDs can modify the release of drugs from different drug delivery systems. 24 Cyclodextrins based formulations for improving patient compliance have been reported.…”