Formulation and In-vitro Evaluation of Sublingual Tablets of Ondansetron Hydrochloride using Coprocessed Excipients

Abstract:

The formulation of sublingual tablets of Ondansetron HCl was carried out by using direct compression technique and evaluation tests were carried out as per pharmacopoeial specifications. Poor compressibility problem of Mannitol was overcome by coprocessing it with maltose and corn starch in varying ratios. The results of evaluation tests indicate that the ratio of Mannitol: Maltose: Corn starch: 19:2:1 gave better tableting performance with respect to precompression & postcompression parameters. It was also observed that increase in maltose content, increased the hardness but negatively affects disintegration and drug release and vice versa. Furthermore the study on effect of superdisintgrants shows that Crospovidone gives faster disintegration and satisfactory drug release in concentration of 4% compared to that of Sodium starch glycolate & Croscarmelose sodium. Formulation using a bioadhesive polymer PVP K 30 in ratio of 0.5% showed uniform release of drug over a period of 20 minutes with complete solubilization of tablet compared to that of gelatin and carbopol 934. On numerical optimization of prepared formulations, three formulations were suggested by Design Expert 8.0.7.1(Trial Version), among that Formulation B gave better correlation between predicted value and observed value. Thus Formulation B was chosen as global best formulation.

Key words: Sublingual Tablet, Direct Compression, Co-processing of excipients, Historical Data Optimization, Ondansetron HCl.