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Published on: August 9, 2022
Bio-relevant dissolution testing of hard capsules prepared from different shell materials using the dynamic open flow
Grzegorz Garbacz1, Dominique Cadé2, Hassan Benameur2
1University of Greifswald, Institute of Pharmacy, Center of Drug Absorption and Transport, Felix-Hausdorff-Strasse 3, 17487 Greifswald, Germany; Physiolution GmbH, Walter-Rathenau-Strasse 49a, 17489 Greifswald, Germany.
Summary
A new dynamic flow test apparatus simulates stomach conditions for drug release testing. This method provides more realistic data for immediate release capsules compared to standard tests.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery
- Biopharmaceutics
Background:
- Current dissolution and disintegration tests do not accurately reflect physiological conditions in the stomach for immediate-release dosage forms.
- Simulating intra-gastric conditions is crucial for understanding drug release, especially under fasting conditions.
Purpose of the Study:
- To develop and evaluate a novel 'dynamic open flow through test apparatus' that mimics physiological gastric conditions.
- To assess the performance of various hard capsules (gelatin, hypromellose, pullulan) under simulated gastric conditions.
Main Methods:
- The dynamic open flow through test apparatus was developed based on a dissolution stress test device.
- The apparatus simulates intra-gastric flow rates, temperature profiles, and gastric motility.
- Five types of hard capsules containing caffeine were tested under dynamic flow conditions.
Main Results:
- Drug release from Vcaps Plus, Vcaps, and Plantcaps was comparable to conventional hard gelatin capsules (HGC) under simulated gastric motility.
- The temperature dependency of gelatin capsule release was identified as a significant factor due to slow heat exchange in the stomach.
Conclusions:
- The dynamic open flow through test apparatus offers a more realistic method for evaluating gastric drug release from immediate-release dosage forms.
- This novel apparatus can provide valuable insights into capsule performance under physiological conditions, aiding in formulation development.
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