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

Mosab Arafat, Molham Sakkal, Mohammad F. Bostanudin, Othman Abdulrahim Alhanbali, Priya Yuvaraju, Rami Beiram, Bassem Sadek, Amal Akour, Salahdein AbuRuz

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)


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.

Original languageEnglish
Article number1325
Publication statusPublished - 2023


  • Analytical Techniques
  • Differential Scanning Calorimetry
  • Enteric Coating Film
  • Generic Drug
  • In vitro Drug Release
  • Pantoprazole
  • Polysorbate 80
  • Thermogravimetric Analysis

ASJC Scopus subject areas

  • General Biochemistry,Genetics and Molecular Biology
  • General Immunology and Microbiology
  • General Pharmacology, Toxicology and Pharmaceutics


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