M. Sudhakar, Vinay Umesh Rao, Nagraju Samalla
The objective of the study was to formulate bilayer tablets consisting of Paracetamol (PM) and Aceclofenac (AC). 100% of the dose of PM and 50% of the dose of AC was formulated as a fast disintegrating and rapidly dissolving layer which was overlaid with a controlled release layer containing the balance 50% of the dose of AC. The IRlayer was designed in a way to achieve complete release of the dose within a 30 min and SR-layer was designed to deliver the dose at a constant rate of 4 to 5 mg % /hour. To optimize the composition of the IR layer the level of Croscarmellose sodium (CCS) in the formulation was optimized. For optimizing the SR layer, HPMC K4M, K15M and K100M at different levels were evaluated and the type and concentration of HPMC was finalized. These results indicated that release of the drug from the tablet was influenced by content of super disintegrant and polymer grade and concentration. Formulation containing 1.5 % w/w of CCS in IR-layer and 6 % w/w of HPMC K100M in SR-layer showed desired drug release. Thus bilayer tablets could be a potential dosage form for delivering Paracetamol as immediate release and Aceclofenac in a controlled release manner.
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