Enteric-coating film effect on the delayed drug release of pantoprazole gastro-resistant generic tablets

Abstract

Background: Enteric coating films in acidic labile tablets protect the drug molecule from the acidic environment of the stomach. However, variations in the excipients used in the coating formulation may affect their ability to provide adequate protection. This study is the first to investigate the potential effects of coating materials on the protective functionality of enteric coating films for pantoprazole (PNZ) generic tablets after their recall from the market. Methods: A comparative analysis was conducted between generic and branded PNZ products, using pure drug powder for identification. The in vitro release of the drug was evaluated in different pH media. The study also utilized various analytical and thermal techniques, including differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), X-ray diffraction (XRD), scanning electron microscopy (SEM), Fourier-transform infrared (FTIR), and confocal Raman microscopy. Results: The in vitro assessment results revealed significant variations in the release profile for the generic product in acidic media at 120 min. DSC and TGA thermal profile analyses showed slight variation between the two products. XRD analysis exhibited a noticeable difference in peak intensity for the generic sample, while SEM revealed smaller particle sizes in the generic product. The obtained spectra profile for the generic product displayed significant variation in peaks and band intensity, possibly due to impurities. These findings suggest that the excipients used in the enteric coating film of the generic product may have affected its protective functionality, leading to premature drug release in acidic media. Additionally, the presence of polysorbate 80 (P-80) in the brand product might improve the properties of the enteric coating film due to its multi-functionality. Conclusions: In conclusion, the excipients used in the brand product demonstrated superior functionality in effectively protecting the drug molecule from acidic media through the enteric coating film, as compared to the generic version.

Effect of Hydration Forms and Polymer Grades on Theophylline Controlled-Release Tablet: An Assessment and Evaluation

“…Overall, the quality of the medication is influenced by several factors: the physicochemical properties of the active ingredient, the types and proportions of excipients used, and their grades. These properties significantly impact the final product’s quality, as evidenced by various studies [ 24 , 25 , 26 , 27 ]. For instance, one study found that the hydrate form of cefdinir released faster than its monohydrate form [ 24 ].…”

“…The integration of thermal and analytical techniques, complemented by in vitro assessments, forms a comprehensive approach for identifying compromised quality and functionality in CDDSs [ 26 , 32 , 33 , 34 , 35 , 36 ]. Essential techniques include differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), X-ray diffraction (XRD), and scanning electron microscopy (SEM).…”

“…These properties significantly impact the final product's quality, as evidenced by various studies. [24][25][26][27]. For instance, one study found that the hydrate form of cefdinir released faster than its monohydrate form [24].…”