Formulation and Evaluation of Gastro-Retentive Floating Tablets of Tegoprazan
Abstract
The present research work was undertaken to develop and optimize a gastro-retentive floating drug delivery system of Tegoprazan for the effective management of gastroesophageal reflux disease (GERD). GERD is a prevalent chronic gastrointestinal disorder characterized by reflux of gastric contents, leading to mucosal damage and reduced quality of life, necessitating prolonged and effective acid suppression therapy. Tegoprazan, a novel potassium-competitive acid blocker (P-CAB), exhibits rapid onset of action and potent acid suppression but possesses a relatively short half-life (3–5 hours), which may require frequent dosing. Therefore, a gastroretentive floating tablet was designed to prolong gastric residence time and achieve sustained drug release. Preformulation studies confirmed the identity and purity of the drug. The melting point was found in the range of 118–122 °C, and UV spectrophotometric analysis showed a λmax at 261 nm with excellent linearity (R² = 0.9993). FTIR studies confirmed characteristic functional groups and indicated no drug–excipient interaction. Floating tablets were prepared using polymers such as Carbopol 934P and Sodium Alginate. Pre- and postcompression parameters were within acceptable limits, indicating good flowability and tablet integrity. Floating studies demonstrated prolonged buoyancy, and in vitro dissolution studies showed sustained drug release up to 24 hours. The optimized formulation (TF9) exhibited 98.86% drug release with excellent…
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