Abstract

The present study was carried out to evaluate the usefulness of sulfobutyl ether β-Cyclodextrin (SBE7-β-CD) in increasing the dissolution rate of tenoxicam. The approach employed to prepare the inclusion complexes of the drug with captisol is by freeze drying and kneading methods. The phase solubility studies indicated that a 1:1 M complex was formed between tenoxicam and captisol. The complexes showed a rapid dissolution compared to the pure drug tenoxicam. In between the kneaded and freeze dried complexes, the freeze dried complex showed higher dissolution rate. The inclusion complexes were evaluated by differential scanning calorimetry (DSC), X-ray diffraction (XRD), and Fourier transform infrared spectroscopy (FT-IR). The drug is found to exist in amorphous state in the complexes. The efficacy of hydrophilic polymers, gelucire and hydroxypropyl cellulose in stabilizing the high dissolving amorphous forms of tenoxicam in the tablet formulations was studied and the findings of the investigation suggested that the hydrophilic polymers were able to offer protection in preventing the transformation of the amorphous drug during compression and storage. It can be concluded from the results of the present study that careful formulation is essential to stabilize the high dissolving forms of drugs to retain their physical stability and high dissolution characteristics.

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