Abstract

STATISTICAL OPTIMIZATION OF FAST DISINTEGRATING TABLETS OF TRAMADOL HCL FOR PAEDIATRIC DELIVERY USING MUCILAGE OF AEGLE MARMELOSE AS SUPERDISINTEGRANT

Bipul Nath*

ABSTRACT

The crucial aspect in the formulation of fast disintegrating tablet is to mask the bitter taste and to minimize the disintegration time. The present study includes design of fast disintegrating tablets of Tramadol HCl by direct compression method using optimized proportions of Aegle marmelose mucilage and Cross Carmellose Sodium as superdisintegrant. A two-factor three-level (32) factorial design is being used to optimize the formulation. Nine formulation batches (F1–F9) were prepared accordingly. Two factors as independent variables (𝑋1-amount of AM and 𝑋2-amount of CCS) were taken with three levels (+1, 0, −1). All the prepared excipient blends were evaluated for pre- compression parameters (angle of repose, Carr’s index, Hausner ratio, etc.) and post compression parameters (weight variation, hardness, and friability, wetting time, disintegration time, water absorption ratio, and in vitro drug release studies). The optimum batch F5 was selected by the Design-Expert software which exhibited DT (28 sec), WT (33 sec), and in vitro drug release (88%) within 15 minutes.

Keywords: .