Clinical Pharmacology & Biopharmaceutics
Open Access

Abstract

The objectives of the present study were to investigate the properties of HME based tablets containing plain ibuprofenparacetamol FDC, without a single excipient and to compare it with marketed formulation by applying QbD approach. Paracetamol and ibuprofen were taken at drug/drug mass ratios (5:2). The prepared physical mixtures were extruded using a corotating twin-screw hot melt extrusion. Among the three tested independent variables in DOE, temperature and feeding rate most significantly affected the tensile strength and drug release from the tablet. The melt extruded granules were passed through a 250�?¼m sieve. The maximum optimized ratio (85:5.5:100) determined by DOE was chosen for further analysis. DSC, XRD, SEM were carried out to determine physicochemical changes after melt granulation. The granules were characterized for particle size analysis, flow properties, granule strength. Tablets containing 500 mg paracetamol and 200 mg ibuprofen were compressed at 10.0kN compaction force. The tablets were characterized for tablet hardness, friability, disintegration time and dissolution study. All results were found to be within acceptable USP limits. The optimized extruded batch was stable at 400C, 75%RH for a period of 6 months without changing any dissolution rate and remained into amorphous state.

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