DEVELOPMENT AND EVALUATION OF ENTERIC-COATED PANTOPRAZOLE TABLETS FOR ENHANCED GASTRIC PROTECTION

Riya Jain*, Dr. R. P. S. Rathore

ABSTRACT

Pantoprazole is a proton pump inhibitor widely used in the management of acid-related gastrointestinal disorders, including gastroesophageal reflux disease, peptic ulcer disease, and Zollinger–Ellison syndrome. Because Pantoprazole is highly unstable in acidic conditions, an enteric coating is essential to protect the drug from degradation in the stomach and ensure its release in the intestinal environment. The present study aimed to formulate and evaluate enteric-coated Pantoprazole tablets with improved stability and effective drug delivery. Preformulation studies were carried out to evaluate the physicochemical properties and compatibility of the drug with selected excipients. Six formulations (F1–F6) were prepared and subjected to pre-compression evaluation, including angle of repose, bulk density, tapped density, Carr's index, and Hausner's ratio, which demonstrated satisfactory flow and compressibility. The core tablets were evaluated for physical appearance, thickness, diameter, weight variation, hardness, friability, drug content, and disintegration time, followed by enteric coating and in vitro dissolution studies. Among the developed formulations, F6 exhibited the most desirable characteristics, including excellent mechanical strength, acceptable friability, uniform drug content, effective resistance to acidic medium, and maximum drug release in phosphate buffer after the enteric coating dissolved. The results confirmed that the optimized enteric-coated formulation successfully protected Pantoprazole from gastric degradation and provided efficient drug release in the intestinal environment. Therefore, formulation F6 was identified as the optimized formulation with suitable pharmaceutical properties and potential for effective oral therapy.

Keywords: Pantoprazole, Enteric-Coated Tablets, Proton Pump Inhibitor, Delayed Drug Release, Tablet Formulation, Pharmaceutical Evaluation, Dissolution Study, Enteric Coating.