The Effect of Particle Size on the Disintegrant Property of Manihot esculenta Starch in Directly Compressed Paracetamol Tablet Formulations

Sammendrag

Background: Starch is one of the most widely used excipients in tablet formulations. The source and processing of starch can influence its properties.

Objective: The study investigated the effect of particle size on the disintegrant ability of oven and spray-dried cassava (Manihot esculenta) starch in paracetamol tablet formulations.

Methods: Cassava starch was isolated from its tubers and oven-dried following standard methods. Particle size ranges of 107-125 and 126-300 µm of the oven-dried isolated starch, commercial spray-dried cassava starch, and maize BP were used to produce five (5) batches of paracetamol powder blends that were evaluated for flow properties such as Hausner’s ratio, Carr’s index, and angle of repose. Powder blends were compressed via direct compression into tablets and evaluated for weight uniformity, friability, disintegration time, and dissolution profiles.

Results: The powder blends exhibited fair to poor flow with angles of repose between 37.93 and 47.84° and Carr’s indices greater than 20 %. All the tablets had uniform weights and were moderately hard (4.43-6.90 kgF) and highly friable (2.71-4.50 %). Tablets formulated with 126-300 µm of the isolated oven-dried starch had the fastest disintegration time while the corresponding tablets from spray-dried starch had the longest disintegration time. Drug release was higher from tablets formulated with oven-dried starch and similar to those with maize starch BP than those with spray-dried starch.

Conclusion: The study revealed that particle size was critical to the disintegrant ability of Manihot esculenta starch in the formulated paracetamol tablets. Oven-dried starch of particle size range 126-300 µm produced rapidly disintegrating tablets.