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Original Research | Pharmaceutical Science | Volume 15 Issue 7, July 2026 | Pages: 1549 - 1558 | India
Development and Comparative Assessment of Crystal Engineered Pantoprazole with Improved Gastric Acid Stability
Abstract: The majority of proton pump inhibitor (PPI) drugs are susceptible to gastric acid degradation and are therefore available as delayed-release enteric products. In this study, Co-crystals (CCRs) and Crystallo-co-agglomerates (CCAs) of Pantoprazole (PNZ) were prepared and compared for the improvement of micromeritic and physicochemical properties with special emphasis on gastric acid stability. A gastric acid stability study was carried out using HPLC method by using 0.1N HCl. New absorption bands were observed in the CCRs batches in FT-IR spectrum which supports the possibility of the formation of the hydrogen bond between PNZ and co-formers. SEM and XRD confirmed the transformation of PNZ to the crystalline form. DSC data showed two endothermic peaks corresponding to the polymorphic forms I and II of PBC and NCT, respectively. The CCAs batch B-1(PNZ-PBC) and B-2 (PNZ-DCP) showed the acid degradation of PNZ up to 95% in simulated gastric fluid. Whereas, CCRs batch A-1 shows the highest acid stability of up to 81%. Thus, it was concluded that the mere development of agglomerates with alkaline material will not able to avoid the gastric degradation of the drug. However, being new solid-state entity, CCRs of PNZ can be an effective strategy for improving the acid stability of the gastric acid-labile drugs.
Keywords: Pantoprazole, Gastric acid stability, Crystal engineering, Co-crystals
How to Cite?: Dishank Purandare, Manasi Palande, "Development and Comparative Assessment of Crystal Engineered Pantoprazole with Improved Gastric Acid Stability", Volume 15 Issue 7, July 2026, International Journal of Science and Research (IJSR), Pages: 1549-1558, https://www.ijsr.net/getabstract.php?paperid=SR26718113724, DOI: https://dx.doi.org/10.21275/SR26718113724