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Tablet Disintegration and Dispersion under In Vivo-like Hydrodynamic Conditions
Jan Lenz1, Frederik Fuest2, Jan Henrik Finke3,4
1Technical Research & Development, Novartis Pharma AG, Fabrikstrasse 2, CH-4056 Basel, Switzerland.
Pharmaceutics
|January 21, 2022
Summary
A new 3D Tomo-LIF imaging method offers biorelevant analysis of tablet disintegration and dispersion. This advanced technique reveals how fluid velocity and disintegrant type impact tablet breakdown, unlike standard disintegration tests.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
- Biomedical Imaging
Background:
- Standard disintegration tests (SDT) offer limited insight into tablet disintegration and dispersion under biorelevant conditions.
- High hydrodynamic forces in physiological environments are not replicated by conventional pharmacopoeial methods.
- Understanding tablet disintegration and dispersion is crucial for predicting Active Pharmaceutical Ingredient (API) release.
Purpose of the Study:
- To introduce and validate 3D tomographic laser-induced fluorescence imaging (3D Tomo-LIF) for analyzing tablet disintegration and dispersion.
- To compare the novel 3D Tomo-LIF method with the standard disintegration test (SDT).
- To investigate the impact of fluid velocity and disintegrant type on tablet disintegration and dispersion under controlled hydrodynamic forces.
Main Methods:
- Application of 3D tomographic laser-induced fluorescence imaging (3D Tomo-LIF) in a flow channel.
- Determination of disintegration time (DT) and time-resolved particle size distribution.
- Case study using tablets with varying porosity, fluorescently labeled polymers, fillers, and disintegrants (NaCMCXL, PVPP).
Main Results:
- 3D Tomo-LIF confirmed the analytical limitations of the SDT.
- Fluid velocity significantly impacted tablet disintegration and dispersion.
- Cross-linked sodium carboxymethyl cellulose (NaCMCXL) resulted in shorter disintegration times compared to polyvinyl polypyrrolidone (PVPP).
- Tablets containing Kollidon VA64 exhibited surface erosion disintegration.
Conclusions:
- 3D Tomo-LIF provides in-depth understanding of tablet functional behavior under in vivo-like hydrodynamic forces.
- The method offers improved biorelevance for assessing disintegration and dispersion compared to SDT.
- This technique enhances comprehension of how material composition and structure influence tablet performance.
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