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Abstract
The performance of colon-targeted solid dosage forms is commonly assessed using standardised pharmacopeial dissolution apparatuses like the USP II or the miniaturised replica, the mini-USP II. However, these fail to replicate the hydrodynamics and shear stresses in the colonic environment, which is crucial for the tablet's drug release process. In this work, computer simulations are used to create a digital twin of a dissolution apparatus and to develop a method to create a digital twin of a tablet that behaves realistically. These models are used to investigate the drug release profiles and shear rates acting on a tablet at different paddle speeds in the mini-USP II and biorelevant colon models to understand how the mini-USP II can be operated to achieve more realistic (i.e., in vivo) hydrodynamic conditions.
The behaviour of the tablet and the motility patterns used in the simulations are derived from experimental and in vivo data, respectively, to obtain profound insights into the tablet's disintegration/drug release processes. We recommend an “on-off” operating mode in the mini-USP II to generate shear rate peaks, which would better reflect the in vivo conditions of the human colon instead of constant paddle speed.
The behaviour of the tablet and the motility patterns used in the simulations are derived from experimental and in vivo data, respectively, to obtain profound insights into the tablet's disintegration/drug release processes. We recommend an “on-off” operating mode in the mini-USP II to generate shear rate peaks, which would better reflect the in vivo conditions of the human colon instead of constant paddle speed.
Original language | English |
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Article number | 106310 |
Number of pages | 13 |
Journal | European Journal of Pharmaceutical Sciences |
Volume | 179 |
Early online date | 18 Oct 2022 |
DOIs | |
Publication status | Published - 1 Dec 2022 |
Bibliographical note
Funding Information:This research was funded by the Engineering and Physical Sciences Research Council (EPSRC), grant number EP/S019227/1 .
Keywords
- Colon, mini-USP II
- Digital twin
- Dissolution profile
- Mathematical modelling
- Smoothed Particle Hydrodynamics (SPH)
ASJC Scopus subject areas
- Pharmaceutical Science
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A Computing Framework for Disclosure for Discrete Multiphysics
Alexiadis, A. (Principal Investigator)
Engineering & Physical Science Research Council
1/01/19 → 30/06/21
Project: Research Councils