FORMULATION AND EVALUATION OF ZOLPIDEM TARTRATE SUBLINGUAL TABLETS
Journal Title: Int J of Pharm Rev& Res - Year 2015, Vol 5, Issue 2
Abstract
In the present study 3.5 mg strength will be going to be prepared and also evaluated for all the physical parameters evaluation and in-vitro drug dissolution studies. The first strategy was developed based on innovator composition to study and evaluate all the parameters. The second strategy was developed as generic version to the innovator by using microcrystalline cellulose and Mannitol of different grades and evaluated for all physical parameters and drug release. First the formulation was designed without incorporating buffering agents and after achieving the satisfactory formulation, buffer system was finally incorporated and new formulation was designed, however this formulation which was made by incorporating the single buffering agent failed to achieve the specifications required for the generic version of INTERMEZZO®. The third strategy was developed as generic version to the innovator by using F-Melt and Mannitol combination to improve the flow properties and the achieving good content uniformity with faster disintegration. The formulation that was developed by direct compression failed to achieve content uniformity and faster disintegration and therefore, wet granulation was preferred. The formulation F9 was designed by wet granulation and evaluated for all physical parameters and also drug release. The formulation F9 has good flow properties, content uniformity and drug release but slightly higher disintegration time was observed. Now this formulation was selected for optimization to achieve faster disintegration time and also single buffer system was incorporated. The final optimized formula F10 was designed so that faster disintegration time was achieved with improved content uniformity, flow properties and drug release. This formulation is competed for the innovator INTERMEZZO® sublingual tablets.
Authors and Affiliations
Meesa. Rajendar , Beedha Saraswathi
Keywords
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