Abstract
Moxifloxacin hydrochloride drug substance used to treat bacterial infections in many different parts of the body and most widely used worldwide. In this study, various high-end physico-chemical techniques are used like PXRD, DSC, TGA, BET SSA and PSD analysis to check the relative differences on the product behaviour. The present work reports an impact of alteration in particle size due to compaction process where increase in particle size has been observed from 15.912 μm to 751.001 μm, decrease in specific surface area from 1.89 m2/g to 0.861 m2/g, decrease in crystallinity from 91.65% to 59.15% and impact of dehydration or loss of water from 3.776% to 1.866%, which were observed during study. All the alterations in the physico-chemical properties impacting the drug manufacturing process and on the bioperformance of the finished product. This research attempt aims to investigate the effects of these modifications on in vitro experiments conducted in the office of generic drugs (OGD) media and the equilibrium solubility profile. The in vitro studies resulted about 35% release difference observed in the initial time points, whereas solubility in water observed about 17 mg/mL difference. This research work helps to demonstrate the optimization of finished product development process to meet the biofriendly formulation.
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