PREPARATION AND IN VITRO CHARACTERIZATION OF SOLID DOSAGE FORM (TABLET) CONTAINING COMBINE DRUGS FOR GASTRIC DISORDER
Ankit Singh*, Pinky Singh, Hemant Agrawal, Naveen Gupta
ABSTRACT
The present study was undertaken to develop and evaluate sustained-release matrix tablets containing Andrographolide and Pantoprazole for the management of gastric disorders. Pre-formulation studies including organoleptic properties, solubility, pH, melting point, UV spectrophotometry, and FTIR analysis were performed to establish the physicochemical characteristics and compatibility of the drugs. Six formulations (F1–F6) were prepared by direct compression using HPMC K-100 and Eudragit RLPO as matrix-forming polymers. The prepared tablets were evaluated for thickness, hardness, friability, weight variation, drug content, and in vitro drug release. All formulations exhibited satisfactory post-compression characteristics and complied with pharmacopeial requirements. Among the formulations, F3 showed the highest drug content (98.86%) and the most desirable sustained-release profile, with approximately complete drug release within 13 h. Release kinetic analysis demonstrated the highest correlation with the Higuchi model (R² = 0.983): indicating diffusion-controlled drug release from the matrix system. Stability studies conducted for three months under long-term (30 ± 2°C/65 ± 5% RH) and accelerated (40 ± 2°C/75 ± 5% RH) conditions showed no significant changes in physical characteristics, drug content, or dissolution behavior. Thus, F3 was identified as the optimized formulation and demonstrated potential as a sustained-release combined dosage form for prolonged gastric disorder management, reduced dosing frequency, and improved patient compliance.
Keywords: Andrographolide, Pantoprazole, Sustained-release tablet, Matrix tablet, HPMC K-100, Eudragit RLPO, Gastric disorders, Stability study.
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