Direct compression of diclofenac sodium tablet using modified Musa paradisiaca pseudostem cellulose-corn starch polymer alloy

Abstract

Background: Biomaterials exhibit different functional properties. The aim of this study is to formulate direct compressible diclofenac sodium tablet using modified pseudostem cellulose and starch complex. Methods: Cellulose was extracted from Musa paradisiaca pseudostem and modified using acid-hydrolysis and fermentation techniques. The modified cellulose was evaluated using FT-IR analysis. Avicel pH-101 was used as control cellulose. Micromeritic properties of the modified cellulose were evaluated using tapped consolidation technique. Co-milling heat technique was used to produce polymer-alloy of 21.7, 43.4 or 87.0% of modified cellulose and 78.3, 56.6, or 13.0% dried corn starch respectively. The dried starch or polymer-alloy was blended with diclofenac sodium, co-povidone and magnesium stearate to produce batches A - G. The blends were analyzed for Kawakita densification properties before being compressed to tablets. The physicochemical and drug-release properties of the tablets were evaluated. Results: Of the dried pseudostem mass, 52.01% and 48.04% of extracted and modified celluloses respectively were obtained. The FTIR study showed presence of cellulose in the pseudostem extract and no interaction between the cellulose and diclofenac sodium. The celluloses had Hausner’s ratios < 1.32 and Carr’s indices < 23.54%. The polymer-alloy blends showed Kawakita compressibility < 16.34 and compactibility > 489.30. The control tablets passed physicochemical properties tests. The test tablets had hardness > 12.34 KgF, disintegration time > 144.67 min, and released 7.64 - 77.59% drug in acidic to basic medium over 240 min. The result indicates that the pseudostem-cellulose was flow-able, and produced compactible polymer alloys and extended drug-release tablets. Conclusion: Direct compression of diclofenac sodium with Musa paradisiaca pseudostem cellulose-corn starch polymer-alloy produced compact tablets with extended drug release. Keywords: Acid-hydrolysis, co-milling, compressibility, drug release