Volume : 13, Issue : 05, May – 2026
Title:
DESIGN, FORMULATION, AND IN‑VITRO CHARACTERIZATION OF FAST DISSOLVING SITAGLIPTIN TABLETS
Authors :
Ravi Sondur*, Basavaraj Shidagonnavar, Pradeep B Mirje
Abstract :
The present study aimed to design, formulate, and evaluate fast-dissolving tablets (FDTs) of Sitagliptin for the effective management of Type 2 Diabetes Mellitus. Eight formulations (F1–F8) were prepared by direct compression using sodium starch glycolate and crospovidone as superdisintegrants. Pre-formulation compatibility studies were performed using FTIR spectroscopy, which confirmed the absence of drug–excipient interactions. The prepared tablets were evaluated for physicochemical parameters, including weight variation, thickness, hardness, friability, drug content, disintegration time, and in-vitro drug release. All formulations complied with pharmacopeial limits for weight variation, hardness (3.18–4.12 kg/cm²), friability (0.43–0.59%), and drug content (88.47–92.35%). The disintegration time ranged between 32–43 seconds, indicating rapid tablet dispersion. In-vitro dissolution studies revealed that all formulations released more than 90% of drug within 60 minutes. Among them, formulation F5 showed the highest cumulative drug release (98.42%) with rapid initial burst release and consistent dissolution behaviour. Drug release kinetics of the optimized formulation F5 followed first-order kinetics with a diffusion-controlled mechanism as confirmed by Zero-order, First-order, Higuchi, and Korsmeyer–Peppas models. Accelerated stability studies conducted for 90 days at 40°C/75% RH demonstrated no significant physical changes and negligible reduction in drug release, confirming formulation stability. The developed fast dissolving tablet of sitagliptin exhibited rapid disintegration, enhanced dissolution, and good stability, suggesting its potential as an effective and patient-compliant oral dosage form for diabetes management.
Keywords: Sitagliptin, Super disintegrates, Direct compression method, Fast dissolving tablets, In vitro drug release studies.
Cite This Article:
Please cite this article in press Ravi Sondur et al., Design, Formulation, And In‑Vitro Characterization Of Fast Dissolving Sitagliptin Tablets.., Indo Am. J. P. Sci, 2026; 13(05).
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