College of Pharmacy, Al Ain University, Al Ain, Abu Dhabi, 64141, United Arab Emirates.
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestinian Territory.
F1000Res. 2023 Oct 12;12:1325. doi: 10.12688/f1000research.140607.1. eCollection 2023.
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. A comparative analysis was conducted between generic and branded PNZ products, using pure drug powder for identification. The 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. The 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. : 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.
肠溶包衣膜在易酸蚀的片剂中可保护药物分子免受胃酸环境的影响。然而，包衣配方中辅料的变化可能会影响其提供充分保护的能力。本研究首次调查了包衣材料对泮托拉唑（PNZ）仿制药片在从市场召回后的肠溶包衣膜保护功能的潜在影响。对仿制药和品牌 PNZ 产品进行了比较分析，使用纯药物粉末进行鉴定。在不同 pH 值的介质中评估了药物的释放情况。该研究还利用了各种分析和热技术，包括差示扫描量热法（DSC）、热重分析（TGA）、X 射线衍射（XRD）、扫描电子显微镜（SEM）、傅里叶变换红外光谱（FTIR）和共焦拉曼显微镜。评估结果表明，在酸性介质中，仿制药在 120 分钟时的释放曲线有显著差异。DSC 和 TGA 热谱分析显示两种产品之间有轻微差异。XRD 分析显示仿制药样品的峰强度有明显差异，而 SEM 显示仿制药的颗粒尺寸较小。仿制药的获得光谱显示峰和带强度有明显变化，可能是由于杂质所致。这些发现表明，仿制药肠溶包衣膜中使用的辅料可能影响了其保护功能，导致在酸性介质中药物过早释放。此外，品牌产品中存在的聚山梨酯 80（P-80）可能因其多功能性而改善了肠溶包衣膜的性能。总之，与仿制药相比，品牌产品中使用的辅料在通过肠溶包衣膜有效保护药物分子免受酸性介质影响方面表现出更好的功能。
