Performance equivalence study of sodium starch glycolate, modified maize starch and maize starch as disintegrants in paracetamol tablet formulation

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