Evaluation as Disintegrant, Acetone-dehydrated Pre-Gelatinized Starch of Arthocarpus altilis Fruits in Oral paracetamol Tablets

Abstract

Introduction: Modifying natural polymers have imparted desirable properties making them suitable as pharmaceutical additives. Aim: This research work was to prepare pre-gelatinized breadfruit starch using acetone to reduce drying time and energy expended. The modified starch was evaluated as a disintegrant in paracetamol oral compacts. Methods: Starch from unripe mature bread fruit was pre-gelatinized, precipitated with acetone to reduce drying time. Native and pre-gelatinized starches were characterized for micromeritics, compatibility studies with test drug using Fourier Transform Infra-Red (FT-IR) and water interaction properties (viscosity, swelling power and hydration capacity). Paracetamol granules formed by wet granulation were compacted incorporating starches as disintegrant intragranularly, extragranularly and combining both methods. Disintegration and dissolution studies done. Results: Pre-gelatinization did not alter the native starch chemically and their pH were within pharmaceutical limits. The disintegration efficiency ratio (DER) for the P2 and P3 (tablet batches with pre-gelatinized starches) compared favourably with that of corn starch. Also, the dissolution kinetics of the breadfruit starches followed the Hixson Crowel’s model while that of reference corn starch was best described by the Higuchi kinetic model. Conclusion: Breadfruit starch is edible and the properties of its pre-gelatinized form as a disintegrant compares favourably with corn starch BP. It could be an good alternative as pharmaceutical excipient.