DEVELOPMENT OF NATEGLINIDE MODIFIED RELEASE DOSAGE FORM USING ELEMENTARY OSMOTIC PUMP (EOP) AND PUSH-PULL OSMOTIC PUMP (PPOP) METHODS

Objective: The aim of the study was to develop osmotic tablets of nateglinide by two methods, namely elementary osmotic pump (EOP) and push-pull osmotic pump (PPOP) method for controlled drug release. Methods: Initially, pre-compression parameters were studies for the tablet blend in both EOP and PPOP methods. The tablets were prepared by the wet granulation method in both methods. The prepared tablets were evaluated for various physicochemical parameters, in-vitro dissolution, and the dissolution data were fitted into kinetic models for knowing the mechanism of drug delivery. The optimized formulation obtained in both methods was further characterized for FTIR and stability studies. Results: In EOP method, P1-P14 formulations prepared before coating exhibited 16h drug release, and after coating (F1-F14) all the formulations exhibited 24h prolonged drug release, with F14 showing the highest drug release of 98.82%. In PPOP method, in-vitro drug release depended on the effect of plasticizer, effect of drug layer to coating weight gain, and osmogen concentration. Finally, formulation FF14 was optimized with the highest drug release of 99.97%, and also its granules had better flow property. F14 and FF14 were the optimized formulations from EOP and PPOP methods. Both were further characterized for FTIR, which showed no significant interaction and the accelerated studies indicated formulations were stable with no variations in hardness, drug content, and drug release for 3 months. Conclusion: To conclude, the EOP and PPOP osmotic tablet of Nateglinide was able to deliver the drug in a controlled pattern for a prolonged period of time.