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Research Gate: Pharmaceutical Science

The Research Gate: Pharmaceutical Science provides a resource content dealing with the Pharmaceutical industry starting from drug discovery process to drug distribution system to patients.

The Research Gate: Pharmaceutical Science aims to publish all the recent and exceptional research articles and reviews in all areas of modern Pharmaceutical industry like drug discovery including in-silico drug design, combinatorial chemistry, new drug targets, Bioinformatics and chemoinformatics, Genomics and proteomics, medicinal chemistry, SAR, high-throughput screening, advances in ADME, drug delivery and Biopharmaceuticals, phytochemistry and pharmacognosy.

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Formulation, Optimization and Comparative Evaluation of Teneligliptin Hydrobromide Oral Dispersible Tablets Using Plantago ovata Mucilage and Synthetic Superdisintegrants

Teneligliptin Hydrobromide
Oral Dispersible Tablet
Plantago ovata
Crospovidone
3² Full Factorial Design
Direct Compression
Natural Superdisintegrant.
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Abstract

Background & Objective: Management of Type 2 Diabetes Mellitus (T2DM) requires strict, lifelong adherence to pharmacotherapy. Dysphagia affects roughly 35% of the population, presenting a barrier to oral solid dosage forms. Teneligliptin Hydrobromide, a novel peptidomimetic Dipeptidyl Peptidase-4 (DPP-4) inhibitor (BCS Class II), suffers from rate-limiting dissolution in gastrointestinal fluids. This study aimed to formulate, optimize, and comparatively evaluate Teneligliptin Hydrobromide Oral Dispersible Tablets (ODTs) using Plantago ovata (Isabgol) mucilage as a natural superdisintegrant against Crospovidone, a synthetic benchmark.

Methods: Plantago ovata mucilage was isolated via aqueous extraction and acetone precipitation. Drug-excipient compatibility was evaluated via Fourier Transform Infrared (FTIR) spectroscopy. ODTs were manufactured using the direct compression method. A 3² full factorial design was applied to optimize Plantago ovata mucilage concentration (X₁) and compression force (X₂). Evaluated responses included disintegration time (Y₁), percentage drug release at 15 minutes (Y₂), tablet hardness (Y₃), and wetting time (Y₄). Pre-compression and post-compression metrics were characterized according to pharmacopeial standards. Results: FTIR spectra showed no significant peak shifts, confirming drug-excipient chemical compatibility. Micromeritic parameters demonstrated acceptable powder flow and compressibility across all blends. The 3² full factorial design identified batch F5 (containing 15 mg Plantago ovata mucilage and compressed at 7 kN) as the overall optimized formulation. Batch F5 achieved an in vitro disintegration time of 18 seconds, a wetting time of 14 seconds, a hardness of 3.5 kg/cm², a friability of 0.38%, content uniformity of 99.7%, and 98.1% cumulative drug release within 15 minutes. Polynomial regression models showed strong predictive capacity (R² > 0.95). Comparative evaluation revealed that Plantago ovata mucilage performance was comparable to synthetic Crospovidone without forming a gel barrier. Conclusion: Plantago ovata mucilage serves as a biocompatible, cost-effective, and efficient natural superdisintegrant for Teneligliptin Hydrobromide ODTs, offering a reliable, eco-friendly alternative for diabetic care.