The Influence of Phosphate Modified and Pregelatinized Plantain (Musa Paradisiaca, Family: Musaceae) Starches as Disintegrants In Paracetamol Tablet Formulations

Abstract

Background: Starch is the commonest disintegrant used in tablet formulation. The use of starch is however limited by its poor functional properties of flow, compressibility and compatibility. Hence, starches are chemically, physically or enzymatically modified to improve the aforementioned properties.
Objective: This study was aimed at investigating the disintegrant property of simultaneously phosphorylated and pregelatinized plantain starch (PPPS) obtained from Musa paradisiaca (Family: Musaceae) in directly compressed paracetamol tablet formulations in comparison with formulations containing natural plantain starch (PS) and sodium starch glycollate BP (SSG).
Method: The extracted plantain starch was purified to yield PS. A portion of PS was simultaneously modified by phosphorylation in 50% v/v monosodium phosphate medium and pregelatinized in the same medium to yield PPPS. The powdered PPPS was characterized using density measurements and Kawakita equations before incorporation as a disintegrant in directly compressed paracetamol tablet formulations at concentrations of 10, 15, 20 and 25 %w/w in comparison with PS and SSG. The tablets were evaluated for their mechanical and release properties. Statistical data was carried out using ANOVA at a significance level of p-values < 0.05.
Result: The yield of PS was 57.6 % w/w. The bulk and tapped densities are of the order PPPS (0.61±0.05 and 0.71±0.13) > PS (0.47±0.05 and 0.53±0.11) > SSG (0.38±0.01 and 0.50±0.01), while the angle of repose are of the order PS (57.100±0.14) > PPPS (35.600±0.01) > SSG (33.700±0.13). The ranking for friability values was PS Tablets>SSG tablets >PPPS tablets. Tensile strength values were of the reverse order for the tablets. Tablets containing PS had the highest disintegration time values at all concentrations, while onset of paracetamol release was fastest from PPPS tablets.
Conclusion: Modification of plantain starch by simultaneous phosphorylation and pregelatinization showed better disintegrant properties than unmodified plantain starch, but comparable with sodium starch glycollate BP.

Keywords: Pregelatinized plantain starch, Phosphate modification, Disintegrant, Paracetamol