The effect of hydrophobicity/hydrophilicity balance of three kinds of adjuvants on pridinol mesylate orally disintegrating tablets and its quality assessment

Abstract

This study was aimed at investigating the effects of 3 kinds of adjuvants on the disintegrating ability of pridinol mesylate orally disintegrating tablets (PMODT), and evaluating the quality of PMODT. The hydrophobic balance of 3 adjuvants (polyvinylpolypyrrolidone (PVPP), microcrystalline cellulose (MCC) and Povidone K30 (PVPK30)) were detected using the L9(34) orthogonal test to determine their effects on the disintegrating ability of PMODT. The quality of PMODT was tested according to the requirements of the Chinese Pharmacopoeia (2010). Results indicated that the disintegrability of PMODT decreased with the increasing amount of PVPP from 4 to 8%. However, no significant influence on the disintegrability was found when the amount of MCC was increased from 10 to 15%. On the other hand, the disintegrability decreased with the increasing amount of MCC when the amount was 15 to 20%. Furthermore, the disintegrability was slightly affected when the amount of PVP K30 was 1 to 2%, while the disintegrability decreased when the amount of PVPK30 was at the range of 2 to 3%. The ratio of hydrophobic / hydrophilic adjuvants affected the disintegrability, which showed a “V” shape curve. The disintegrating tablets showed best property when the ratio of PVPP+MCC and PVPK30 (hydrophobicity / hydrophilicity) was 9.5. The results of hydrophobic balance test on the three kinds of adjuvants were consistent with the results of orthogonal test. In general, the quality of 3 batches of PMODT met the relevant requirements of the production of orally disintegrating tablets. This will provide new ideas and methods for thescreening and dosage choice of variety of adjuvants in the study of pharmaceutical preparation. Key words: Adjuvants, hydrophobicity, orally disintegrating tablets, orthogonal design, disintegration.