INFLUENCE OF PARTIALLY AND FULLY PREGELATINIZED STARCH ON THE PHYSICAL AND SUSTAINED-RELEASE PROPERTIES OF HPMC-BASED KETOPROFEN ORAL MATRICES

Abstract

Objective: This study aims to investigate the effect of two types of pregelatinized starch on the physical performance of HPMC matrices containing Ketoprofen as a model drug. Methods: The design of the experiment was inspired by the monothetic analysis, in which testing factors or causes is done one factor or cause at a time, to achieve system improvements. Tablets were prepared by direct compression. The impact of the type of modified starch on the tablet's physicochemical properties was studied by testing for weight variation, friability, hardness, and drug release properties. PCP dissolution software was used to investigate the kinetics of drug release from matrix tablet formulation. Results: The impact of the type of modified starch on tablet physicochemical attributes revealed that the weight variation of tablets was affected by the amount of modified starch used and that the combination of 64.7% partially pregelatinized starch (StarchÒ 1500) with 9.5% HPMC (F8) was found to be the better in terms of weight variation (%RSD= 1.73%) when compared with those containing fully pregelatinized starch (LYCATABÒ). All formulation runs have friability that complies with pharmacopeial limits of less than 1% loss upon test conduction except for (F1). Formulations containing LYCATABÒ showed better friability than those containing StarchÒ 1500, and similar results were observed in tablet hardness as well, in which the formulation containing the highest LYCATABÒconcentration showed a significant increase in mechanical strength (P = 0.0004) than those containing the highest concentration of StarchÒ 1500. Finally, all formulations containing LYCATABÒexhibited sustained-release behavior, less than 60% of the drug was released from matrices over 14 h, and it is believed that the drug is transported via Fickian diffusion and followed either Higuchi or Peppas model (n>0.5), while all formulations containing StarchÒ 1500 released ~90% of the drug around 2 h, this might probably be due to the high disintegration effect of the partially pregelatinized starch, which is lost upon full pregelatinization. Conclusion: Tablet weight variation, hardness, friability, and T50% were found to be influenced by both the type and concentration of modified starch used. While drug release characteristics were greatly affected by the type of modified starch used. For sustain-release formulations, only fully pregelatinized starch is thought to be suitable.