FORMULATION AND EVALUATION OF BILAYER TABLET CONTAINING DICLOFENAC SODIUM AS SUSTAINED RELEASE AND ALOE VERA GEL POWDER AS IMMEDIATE RELEASE
Keywords:Bilayer tablet, Diclofenac sodium, Aloe Vera gel powder, HPMC K4M, Immediate release, Sustained release, Direct compression
Objective: The objective of the present investigation is to design formulate and characterized the bilayer tablet containing Diclofenac sodium and Aloe Vera gel powder. In which diclofenac sodium is sustained release and Aloe Vera gel powder is immediate release. In order to produce a single dosage form containing two different classes, drug are widely prescribed by the physician to have better patient compliance.
Methods: Bilayer tablet was prepared by direct compression, The immediate release layer of Aloe Vera gel powder was prepared by using different excipients such as starch, sodium starch glycolate, lactose, talc etc. sustained release layer of diclofenac sodium was prepared by using HPMC K4M, lactose, Talc Magnesium stearate, talc etc. for preparation of bilayer tablet sodium starch glycolate are use as super disintegrants in immediate release tablet and HPMC K4M are use as controlled release polymer. Various Preformulation parameter i.e. Identification, melting point, compatibility study, solubility are checked. Micromeritics properties of powder blend such as bulk density, tapped density, hausner’s ratio, Carr’s index, angle of repose are performed. Post-compression parameter was done such as hardness, friability, weight variation, drug content uniformity, thickness, in vitro drug release.
Results: Result was found within the limit of the standard of optimized formulation. The drug release of the tablet was in the range of 82 to 92%in 8 h.
Conclusion: Bilayer tablet was prepared by optimized batches of both layers. The prepared tablets showed satisfactory results for various evaluation parameters. The optimized formulation based on all the parameter A1 (Sodium starch glycolate) is selected for the immediate release layer and D3 (HPMC K4M) was selected for the controlled release layer. The drug release mechanism was found to be zero order release depends upon diffusion.
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