ABSTRACT
Fierce price competition informed the reappraisal and reformulation of paracetamol tablet. Sodium starch glycolate [SSG] was implicated in the high cost and needed to be replaced. The use of modified maize starch [MMS] produced by cold, dilute acid hydrolysis of maize starch [MS] offered good and cheaper alternative. Evaluation of different disintegrants using 5 batch formulations coded SSG-3, MS-3, MMS-3, MMS-6 and MMS-9 and characterization of resultant tablets showed that interchanging SSG with MMS resulted in no deleterious therapeutic consequences. Inclusion of 6% MMS in the paracetamol formulation gave tablets that exhibited good mechanical and dissolution properties comparable to the tablets produced with 3% sodium starch glycolate. Indeed, at 95% confidence level, t-test which compares the p-value [?0.05] of dissolution of the batch formulations returned values of 0.000056 for MS-3, 0.0182 for MMS-3, 0.0965 for MMS-6 and 0.1433 for MMS-9. The values confirmed the significant differences between batch SSG-3 and batches MS-3 and MMS-3 and no difference of any significance in batches MMS-6 and MMS-9. Hence MS and MMS at 3% level can not effectively replace SSG at 3% level. The poor friability [1.12%] as well as higher disintegration time [16 minutes, 54 seconds], both higher than official limits of<1% and ?15 minutes respectively, would not also allow the use of MMS at 3 and 9% level as substitutes for 3% SSG. Thus, only MMS at 6% inclusion level can interchange with SSG 3%. Cost-benefit analysis showed that over 9% cost reduction is achieved by the replacement without compromising both physical and chemical qualities of the resultant tablets which include mean dissolution time [MDT] 50% of 4.5 minutes and dissolution of 103.87% in 30 minutes