Encapsulation of Lornoxicam into spermaceti microspheres and comparative bioavailability study
Keywords:
Lornoxicam, Wax microspheres, Release kinetics, Bioavailability, BioequivalenceAbstract
In this study, Lornoxicam (LX) loaded spermaceti (SC) microspheres were prepared using meltable emulsified dispersion cooling induced solidification technique and the bioavailability of the marketed product (Flexispaz® capsule-reference-product A) was compared with the optimized formulation (lornoxicam loaded spermaceti microspheresătestăproduct B). Morphological studies of wax microspheres were evaluated using scanning electron microscopy (SEM). The SEM images showed the spherical shape of wax microspheres and more than 97% of the isolated microspheres were in the size range 309-317 μm. Differential scanning calorimetry (DSC), Fourier transforms infrared (FTIR) spectroscopy and stability studies showed that the drug after encapsulation with SC microspheres was stable and compatible. A single dose, randomized, complete cross over study of LX (8mg) microspheres were carried out on 10 healthy male and female Albino sheepÊs under fasting conditions. Plasma LX concentrations and other pharmacokinetic parameters obtained were statistically analyzed. Based on this study, it can be concluded that drug loaded LX microspheres and Flexispaz® capsule are bioequivalent in term of the rate and extent of absorption.
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