Volume : 13, Issue : 07, July – 2026
Title:
FORMULATION AND EVALUATION OF IMMEDIATE RELEASE TABLETS OF SITAGLIPTIN PHOSPHATE
Authors :
Dr. Shaik Shabbeer Thatikunta Laxmi, Vallishetty Tejasri, Dr. P Poli Reddy*
Abstract :
To optimize the clinical management of type 2 diabetes mellitus, this study focuses on the design, development, and comprehensive evaluation of immediate-release Sitagliptin oral tablets using diverse functional excipients and comparative manufacturing techniques. Formulations were systematically fabricated using both wet granulation and direct compression methods, followed by rigorous pre-compression blend evaluations and post-compression quality control testing, including hardness, thickness, weight variation, friability, and in vitro dissolution. Among the evaluated trials, the optimized formulation F4, prepared via wet granulation, exhibited superior mechanical integrity with a friability profile well within the statutory <1% limit and strict adherence to pharmacopeial standards. Notably, F4 demonstrated an accelerated dissolution profile, achieving near-complete drug release (>90% within 30 minutes), thereby establishing a reproducible, industrially viable framework for producing Sitagliptin tablets with enhanced dissolution characteristics and robust therapeutic efficacy.
Keywords: Sitagliptin Phosphate; Immediate Release Tablets; Type 2 Diabetes Mellitus; Direct Compression; DPP-4 Inhibitor; Super disintegrants; In Vitro Dissolution Study.
Keywords: LC–MS/MS, Liquid Chromatography–Tandem Mass Spectrometry, Drug Analysis.
Cite This Article:
Please cite this article in press Shaik Shabbeer et al., Formulation And Evaluation Of Immediate Release Tablets Of Sitagliptin Phosphate, Indo Am. J. P. Sci, 2026; 13(07).
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