.

ISSN 2063-5346
For urgent queries please contact : +918130348310

Formulation Development and Evaluation of Immediate Release for The Treatment of Diabetes Mellitus of Teneligliptin

Main Article Content

Pankaj Kumar Sharma, Rabnoor Alam, Kamini Sharma
» doi: 10.48047/ecb/2023.12.si4.419

Abstract

Teneligliptin instant release tablets were developed and evaluated as part of this study utilizing a wet granulation technique and various ratios of super-disintegrates and binder. It falls under Biopharmaceutical Classification System Class II. The results of the early pre-formulation experiments were found to be within the bounds. All of the aforementioned batches were made, and the granules' pre-compression characteristicssuch as loss on drying, bulk density, tapped density, and compressibility indexwere assessed. Tablets' weight fluctuation, thickness, hardness, and friability were assessed; the assay and disintegration time were found to be within acceptable ranges. The effects of several superdisintegrants were investigated during in vitro dissolutions in a 6.8 PH phosphate buffer. The formulation F8 revealed a 91% drug release within 30 minutes, according to dissolving studies, which were used to make the final formulation choice. In vitro drug release was demonstrated by formulation (F8), which contained 2% each of polyplasdone XL 10 and meglumine and 20% binder, according to similarity and difference characteristics. The in vitro drug release profile shows that there was an increase in drug release with increased concentrations of polyplasdone XL 10 and meglumine 2% and decreased binder concentration (20%). For the optimized batch, accelerated stability investigations were carried out, and the results showed that the drug content and in vitro dissolution were unchanged.

Article Details