ASSESSMENT OF BENECEL™ HYPROMELLOSE GRADES IN THE DEVELOPMENT OF SUSTAIN RELEASE GABAPENTIN TABLETS

Purpose: The purpose of this work was to assess the impact of Benecel DC grades on gabapentin product development.Commercial Gabapentin tablets are manufactured using a high-shear granulation and fluid-bed granulation process, but this process has several disadvantages like increasing the complexity of the process and increasing the manufacturing cycle time.To avoid a granulation step completely, direct compression is a suitable method for the formulation of sustained release gabapentin tablets.Methods: The tablets were prepared by direct compression method along with hydrophilic matrix materials like Benecel K4 PH DC, Benecel K15 PH DC and Benecel K100 PH DC.The blends were evaluated for DSC analysis, FTIR analysis, bulk density, angle of repose, and compressibility index.The tablets were subjected to thickness, diameter, weight variation test, drug content, hardness, friability, kinetic model and in vitro release studies.Results: The preformulation results suggested that the benecel grades are suitable as DC material.The results of the FTIR & DSC study showed that there was no interaction between Gabapentin & Benecel K5, Benecel K15, Benecel K100.The in-vitro dissolution study, kinetic model, drug content, swelling index, and stability studies showed good results.Conclusion: According to the industry perspective, the benecel DC grade should provide better performance in direct compression applications than standard grades of HPMC, as well as reduce process complexity, low cost, and manufacturing cycle time.