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Pancrease gastroresistance: in vitro evaluation of pH-determined dissolution.

C Lenaerts1, N Beraud, J P Castaigne

  • 1Center Hospitalier, Universitaire D'Amiens, France.

Journal of Pediatric Gastroenterology and Nutrition
|January 1, 1988
PubMed
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Pancreatic enzymes (Pancrease) were enteric-coated to prevent stomach inactivation. In vitro tests confirmed Pancrease resists stomach acid, dissolving effectively in the small intestine for optimal therapeutic benefit.

Area of Science:

  • Gastroenterology
  • Pharmacology
  • Drug Delivery Systems

Background:

  • Pancreatic enzymes are crucial for digestion but susceptible to stomach acid inactivation.
  • Enteric coating protects sensitive medications from gastric degradation.
  • Pancrease is formulated as pH-sensitive microspheres for oral delivery of pancreatic enzymes.

Purpose of the Study:

  • To evaluate the pH-dependent dissolution profile of Pancrease.
  • To confirm the gastroresistance of Pancrease under simulated gastric conditions.
  • To assess the dissolution rate in simulated intestinal fluid.

Main Methods:

  • In vitro dissolution testing of three Pancrease batches across a pH range of 1 to 8.
  • Assay method 1: Enzyme absorbency measurement at 280 nm.

Related Experiment Videos

  • Assay method 2: Proteolytic activity assay at pH 6.8.

    • Main Results:

    • Significant enzyme dissolution initiated at pH 5.5, peaking at pH 6.0.
    • Complete dissolution occurred within 15 minutes at pH 6.8 (simulated intestinal fluid).
    • Minimal dissolution (<13%) observed at pH 5.0 after 2 hours, demonstrating gastric resistance.

    Conclusions:

    • Pancrease exhibits robust gastroresistance due to its enteric coating.
    • Enzyme release is targeted to the duodenum and jejunum.
    • This formulation ensures maximal enzymatic efficacy for exocrine pancreatic insufficiency.