Formulation and Evaluation of Fast Disintegrating Oral Tablets of Ibuprofen using Mannitol, PEG 4000, Cellactose and Sodium Starch Glycolate via Direct Compression

Abstract

Background: The needs for improve drug bioavailability has led to the development of new excipients and combination of existing excipients to yield the desired purpose. This study seeks to develop an orally fast dissolving mouth disintegrating tablet of ibuprofen using PEG 4000, mannitol, cellactose and sodium starch glycolate as a preferred alternative for patient compliance and easy administration to geriatric patients. Method: Ten batches (A1, A2, A3, B1, B2, B3, C1, C2, C3, D1, D2, & D3,) of mixture of drug and various excipients combinations were developed and evaluated for powder properties. Tablets, equivalent of 500 mg of all the batches were compacted by direct compression method, on a Cadmach rotary tableting machine using 12.5 mm round-faced punches with pressure load of 10 KN. The compressed MDTs were evaluated for friability, weight variation, hardness, content uniformity, disintegration time, in vitro drug release and tablet oral taste. Results: The results of powder flow properties and tablets analysis for all batchesA– D, batchA3, B1, B2, B3, and C1 showed promising characteristics for an ideal MDT with average powder flow rate, tablet disintegration time, T90%, crushing strength and taste as follow: A3 (1.58 gs-1, 2.09 s, 115 N, 7.5 min. and acceptable taste) respectively; B1 (1.54 gs-1, 2.01 s, 60 N, 6.5 min. and slight bitterness) respectively; B2 (1.58 gs-1, 1.52 s, 60 N, 5.5 min. and slight bitterness) respectively; B3 (1.61 gs-1, 1.05 s, 40 N, 5.0 min. and slight bitterness) respectively; C1 ( 1.72 gs-1, 0.57 s, 55 N, 4.0 min. and acceptable) respectively. Based on these characteristics, formulation batch C1 is more qualified for formulation of fast dissolving MDT. Conclusion: The fast-disintegrating oral tablets of batch C1 possessed the ideal characteristics for physical stability and rapid release ofAPI which is an indication of improved bioavailability.