Optimization of binder, disintegrant and compression pressure for paracetamol tablet formulations

Abstract

The composition of pharmaceutical formulations at developmental stage is often subjected to trials and errors in order to find the best formula and composition of ingredients, and this can be time consuming and wasteful. Optimization by means of experimental design was used to study the effect of three factors on three tablet responses with a view to reducing the long time expended during developmental stage. This was done by studying the contributions of variable factors of binder concentration, disintegrant concentration and compression pressure to tablet friability, hardness and disintegration time under factor combinations given by 23 factorial experimental designs. The effect of every factor was determined by finding the average response of all the combinations in which the factor occurs at high level and subtracting the mean responses resulting from all the combinations in which the factor occurs at low level. The significance of each effect was then determined by a student t-test when degree of freedom, Ô = (n1 + n2 - 2) = 6 and P = 5 %. The results show that the factors had effect on the responses depending on their concentration ranges and the ratio in which they occurred in the factorial combination.

KEYWORDS: Binder, disintegrant, compression pressure, factorial combination, significance,
responses.