Dr. BA Patel, Mehul B Vyas, Dr. Rahil Bhura, Dr. Samir K Shah, Abhishek Raj and Dr. Vijay Parmar
The primary objective of this study was to formulate bilayer tablets of Zaltoprofen (sustained release) and Hibiscus Rosa Sinensis Leaf Powder (immediate release) in which the dose of Zaltoprofen was 500 mg and the dose of Hibiscus Rosa Sinensis Leaf Powder was 1 mg and 2 mg. The tablets were prepared by wet granulation. In this study, Hibiscus Rosa Sinensis Leaf Powder layer was formulated in the form of immediate release as an initial dose and Zaltoprofen layer was in the form of sustained release to act as maintenance dose. The sustained release layer of Zaltoprofen was prepared by using HPMC K100 M polymer. The prepared tablets were evaluated for various physicochemical parameters such as drug-excipient interaction by FTIR, flow properties, hardness, weight variation, thickness, friability, disintegration time for Hibiscus Rosa Sinensis Leaf Powder layer, in vitro dissolution studies, assay and uniformity of content. The formulated tablets were found to be similar in drug release profile to that of market sample. These tablets were also subjected for real time and accelerated stability studies as per ICH guidelines. These tablets were found to be stable even after 6 months of stability study as all the parameters were within limit as per the specifications.
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