{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,31]],"date-time":"2026-07-31T19:49:29Z","timestamp":1785527369908,"version":"3.56.0"},"reference-count":60,"publisher":"MDPI AG","issue":"6","license":[{"start":{"date-parts":[[2021,6,10]],"date-time":"2021-06-10T00:00:00Z","timestamp":1623283200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000266","name":"Engineering and Physical Sciences Research Council","doi-asserted-by":"publisher","award":["EP\/S019227\/1"],"award-info":[{"award-number":["EP\/S019227\/1"]}],"id":[{"id":"10.13039\/501100000266","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceutics"],"abstract":"<jats:p>For colonic drug delivery, the ascending part of the colon is the most favourable site as it offers the most suitable environmental conditions for drug dissolution. Commonly, the performance of a drug formulation is assessed using standardised dissolution apparatus, which does not replicate the hydrodynamics and shear stress evoked by wall motion in the colon. In this work, computer simulations are used to analyse and understand the influence of different biorelevant motility patterns on the disintegration\/drug release of a solid dosage form (tablet) under different fluid conditions (viscosities) to mimic the ascending colonic environment. Furthermore, the ability of the motility pattern to distribute the drug in the ascending colon luminal environment is analysed to provide data for a spatiotemporal concentration profile. The motility patterns used are derived from in vivo data representing different motility patterns in the human ascending colon. The applied motility patterns show considerable differences in the drug release rate from the tablet, as well as in the ability to distribute the drug along the colon. The drug dissolution\/disintegration process from a solid dosage form is primarily influenced by the hydrodynamic and shear stress it experiences, i.e., a combination of motility pattern and fluid viscosity. Reduced fluid motion leads to a more pronounced influence of diffusion in the tablet dissolution process. The motility pattern that provoked frequent single shear stress peaks seemed to be more effective in achieving a higher drug release rate. The ability to simulate drug release profiles under biorelevant colonic environmental conditions provides valuable feedback to better understand the drug formulation and how this can be optimised to ensure that the drug is present in the desired concentration within the ascending colon.<\/jats:p>","DOI":"10.3390\/pharmaceutics13060859","type":"journal-article","created":{"date-parts":[[2021,6,10]],"date-time":"2021-06-10T03:48:08Z","timestamp":1623296888000},"page":"859","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Modelling and Simulation of the Drug Release from a Solid Dosage Form in the Human Ascending Colon: The Influence of Different Motility Patterns and Fluid Viscosities"],"prefix":"10.3390","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4857-7768","authenticated-orcid":false,"given":"Michael","family":"Sch\u00fctt","sequence":"first","affiliation":[{"name":"School of Chemical Engineering, University of Birmingham, Birmingham B15 2TT, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7524-2800","authenticated-orcid":false,"given":"Konstantinos","family":"Stamatopoulos","sequence":"additional","affiliation":[{"name":"School of Chemical Engineering, University of Birmingham, Birmingham B15 2TT, UK"},{"name":"Biopharmaceutics, Pharmaceutical Development, PDS, MST, RD Platform Technology & Science, GSK, David Jack Centre, Park Road, Ware SG12 0DP, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8729-9951","authenticated-orcid":false,"given":"Hannah K.","family":"Batchelor","sequence":"additional","affiliation":[{"name":"Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark J. H.","family":"Simmons","sequence":"additional","affiliation":[{"name":"School of Chemical Engineering, University of Birmingham, Birmingham B15 2TT, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9240-3517","authenticated-orcid":false,"given":"Alessio","family":"Alexiadis","sequence":"additional","affiliation":[{"name":"School of Chemical Engineering, University of Birmingham, Birmingham B15 2TT, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2021,6,10]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"17","DOI":"10.1016\/S2468-1253(19)30333-4","article-title":"The global, regional, and national burden of inflammatory bowel disease in 195 countries and territories, 1990\u20132017: A systematic analysis for the Global Burden of Disease Study 2017","volume":"5","author":"Alatab","year":"2020","journal-title":"Lancet Gastroenterol. Hepatol."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"362","DOI":"10.1109\/JMEMS.2016.2524542","article-title":"A swallowable smart pill for local drug delivery","volume":"25","author":"Goffredo","year":"2016","journal-title":"J. Microelectromech. Syst."},{"key":"ref_3","doi-asserted-by":"crossref","unstructured":"Teruel, A.H., Gonzalez-Alvarez, I., Bermejo, M., Merino, V., Marcos, M.D., Sancenon, F., Gonzalez-Alvarez, M., and Martinez-Manez, R. (2020). New insights of oral colonic drug delivery systems for inflammatory bowel disease therapy. Int. J. Mol. Sci., 21.","DOI":"10.3390\/ijms21186502"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"731","DOI":"10.1208\/s12249-015-0350-9","article-title":"Colon-targeted oral drug delivery systems: Design trends and approaches","volume":"16","author":"Amidon","year":"2015","journal-title":"AAPS PharmSciTech"},{"key":"ref_5","unstructured":"Johnson, L.R. (1994). Physiology of the Gastrointestinal Tract, Raven Press. [3rd ed.]."},{"key":"ref_6","first-page":"22","article-title":"Novel colon specific drug delivery system: A review","volume":"4","author":"Kumar","year":"2012","journal-title":"Int. J. Pharm. Pharmaceut. Sci."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"2629","DOI":"10.1021\/acs.molpharmaceut.7b00095","article-title":"Magnetic resonance imaging quantification of fasted state colonic liquid pockets in healthy humans","volume":"14","author":"Murray","year":"2017","journal-title":"Mol. Pharm."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"893","DOI":"10.3109\/03639049709148695","article-title":"Colonic drug delivery","volume":"23","author":"Watts","year":"1997","journal-title":"Drug Dev. Ind. Pharm."},{"key":"ref_9","unstructured":"Qiu, Y., Chen, Y., Zhang, G.G.Z., Liu, L., and Porter, W.R. (2009). Developing Solid Oral Dosage Forms, Academic Press."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"211","DOI":"10.1007\/s40268-015-0097-5","article-title":"Dissolution of commercially available mesalamine formulations at various pH levels","volume":"15","author":"Tenjarla","year":"2015","journal-title":"Drugs RD"},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"9","DOI":"10.1016\/j.ejpb.2016.08.004","article-title":"Dissolution profile of theophylline modified release tablets, using a biorelevant Dynamic Colon Model (DCM)","volume":"108","author":"Stamatopoulos","year":"2016","journal-title":"Eur. J. Pharm. Biopharm."},{"key":"ref_12","doi-asserted-by":"crossref","unstructured":"Sch\u00fctt, M., Stamatopoulos, K., Simmons, M.J.H., Batchelor, H.K., and Alexiadis, A. (2020). Modelling and simulation of the hydrodynamics and mixing profiles in the human proximal colon using Discrete Multiphysics. Comput. Biol. Med., 121.","DOI":"10.1016\/j.compbiomed.2020.103819"},{"key":"ref_13","doi-asserted-by":"crossref","unstructured":"Stamatopoulos, K., Karandikar, S., Goldstein, M., O\u2019Farrell, C., Marciani, L., Sulaiman, S., Hoad, C.L., Simmons, M.J.H., and Batchelor, H.K. (2020). Dynamic colon model (DCM): A cine-MRI informed biorelevant in vitro model of the human proximal large intestine characterized by positron imaging techniques. Pharmaceutics, 12.","DOI":"10.3390\/pharmaceutics12070659"},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"1426","DOI":"10.1111\/nmo.12403","article-title":"Stimulation of colonic motility by oral PEG electrolyte bowel preparation assessed by MRI: Comparison of split vs single dose","volume":"26","author":"Marciani","year":"2014","journal-title":"Neurogastroenterol. Motil."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"1443","DOI":"10.1111\/nmo.12408","article-title":"Quantification of in vivo colonic motor patterns in healthy humans before and after a meal revealed by high-resolution fiber-optic manometry","volume":"26","author":"Dinning","year":"2014","journal-title":"Neurogastroenterol. Motil."},{"key":"ref_16","doi-asserted-by":"crossref","unstructured":"Sarna, S.K. (2010). Colonic Motility: From Bench Side to Bedside, Morgan & Claypool Publishers.","DOI":"10.4199\/C00020ED1V01Y201011ISP011"},{"key":"ref_17","doi-asserted-by":"crossref","unstructured":"Alexiadis, A. (2015). The discrete multi-hybrid system for the simulation of solid-liquid flows. PLoS ONE, 10.","DOI":"10.1371\/journal.pone.0124678"},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"80","DOI":"10.1016\/j.piutam.2015.03.010","article-title":"A new framework for modelling the dynamics and the breakage of capsules, vesicles and cells in fluid flow","volume":"16","author":"Alexiadis","year":"2015","journal-title":"Procedia IUTAM"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"188","DOI":"10.1016\/j.compbiomed.2017.01.003","article-title":"Using discrete multi-physics for detailed exploration of hydrodynamics in an in vitro colon system","volume":"81","author":"Alexiadis","year":"2017","journal-title":"Comput. Biol. Med."},{"key":"ref_20","doi-asserted-by":"crossref","unstructured":"Ariane, M., Allouche, M.H., Bussone, M., Giacosa, F., Bernard, F., Barigou, M., and Alexiadis, A. (2017). Discrete multi-physics: A mesh-free model of blood flow in flexible biological valve including solid aggregate formation. PLoS ONE, 12.","DOI":"10.1371\/journal.pone.0174795"},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"34","DOI":"10.1016\/j.compbiomed.2018.01.010","article-title":"Discrete multi-physics simulations of diffusive and convective mass transfer in boundary layers containing motile cilia in lungs","volume":"95","author":"Ariane","year":"2018","journal-title":"Comput. Biol. Med."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"96","DOI":"10.1016\/j.compbiomed.2017.07.020","article-title":"Modelling and simulation of flow and agglomeration in deep veins valves using discrete multi physics","volume":"89","author":"Ariane","year":"2017","journal-title":"Comput. Biol. Med."},{"key":"ref_23","doi-asserted-by":"crossref","unstructured":"Mohammed, A.M., Ariane, M., and Alexiadis, A. (2020). Using discrete multiphysics modelling to assess the effect of calcification on hemodynamic and mechanical deformation of aortic valve. ChemEngineering, 4.","DOI":"10.20944\/preprints202004.0107.v1"},{"key":"ref_24","doi-asserted-by":"crossref","unstructured":"Liu, G.R., and Liu, M.B. (2003). Smoothed Particle Hydrodynamics: A Meshfree Particle Method, World Scientific.","DOI":"10.1142\/9789812564405"},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"1339","DOI":"10.1007\/s00371-014-1015-5","article-title":"Elastic moduli of simple mass spring models","volume":"31","author":"Kot","year":"2015","journal-title":"Vis. Comput."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"1081","DOI":"10.1109\/TVCG.2007.1055","article-title":"Identification of spring parameters for deformable object simulation","volume":"13","author":"Lloyd","year":"2007","journal-title":"IEEE Trans. Visualizat. Comput. Graph."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"243","DOI":"10.1007\/s11242-012-9955-6","article-title":"Lattice spring models","volume":"93","author":"Pazdniakou","year":"2012","journal-title":"Trans. Porous Media"},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"290","DOI":"10.1108\/HFF-05-2019-0437","article-title":"Numerical simulation of dissolution of solid particles in fluid flow using the SPH method","volume":"30","author":"Rahmat","year":"2020","journal-title":"Int. J. Numer. Methods Heat Fluid Flow"},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"1027","DOI":"10.1111\/j.1572-0241.2000.01839.x","article-title":"Spatial and temporal organization of pressure patterns throughout the unprepared colon during spontaneous defecation","volume":"95","author":"Bampton","year":"2000","journal-title":"Am. J. Gastroenterol."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"512","DOI":"10.1111\/j.1365-2982.2007.01060.x","article-title":"Proximal colonic propagating pressure waves sequences and their relationship with movements of content in the proximal human colon","volume":"20","author":"Dinning","year":"2008","journal-title":"Neurogastroenterol. Motil."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"485","DOI":"10.1097\/00006231-199306000-00012","article-title":"Noninvasive measurement of human ascending colon volume","volume":"14","author":"Badley","year":"1993","journal-title":"Nucl. Med. Commun."},{"key":"ref_32","first-page":"163","article-title":"Colon specific drug delivery systems: A review on various pharmaceutical approaches","volume":"2","author":"Prasanth","year":"2012","journal-title":"J. Appl. Pharm. Sci."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"1013","DOI":"10.1086\/112164","article-title":"A numerical approach to the testing of the fission hypothesis","volume":"82","author":"Lucy","year":"1977","journal-title":"Astronom. J."},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"374","DOI":"10.1016\/0021-9991(83)90036-0","article-title":"Shock simulation by the particle method SPH","volume":"52","author":"Monaghan","year":"1983","journal-title":"J. Comput. Phys."},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"1703","DOI":"10.1088\/0034-4885\/68\/8\/R01","article-title":"Smoothed particle hydrodynamics","volume":"68","author":"Monaghan","year":"2005","journal-title":"Rep. Prog. Phys."},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"127","DOI":"10.1155\/2010\/586092","article-title":"Mesalazine in inflammatory bowel disease: A trendy topic once again?","volume":"24","author":"Iacucci","year":"2010","journal-title":"Can. J. Gastroenterol."},{"key":"ref_37","doi-asserted-by":"crossref","first-page":"137","DOI":"10.4292\/wjgpt.v6.i4.137","article-title":"Mesalazine preparations for the treatment of ulcerative colitis: Are all created equal?","volume":"6","author":"Ye","year":"2015","journal-title":"World J. Gastrointest. Pharmacol. Ther."},{"key":"ref_38","doi-asserted-by":"crossref","first-page":"1285","DOI":"10.1023\/A:1018909527659","article-title":"Evaluation of the physicochemical properties and dissolution characteristics of mesalamine\u2014Relevance to controlled intestinal drug-delivery","volume":"10","author":"French","year":"1993","journal-title":"Pharm. Res."},{"key":"ref_39","doi-asserted-by":"crossref","first-page":"327","DOI":"10.1111\/nmo.12727","article-title":"Colon wall motility: Comparison of novel quantitative semi-automatic measurements using cine MRI","volume":"28","author":"Hoad","year":"2016","journal-title":"Neurogastroenterol. Motil."},{"key":"ref_40","first-page":"64","article-title":"Mathematical comparison of curves with an emphasis on in vitro dissolution profiles","volume":"20","author":"Moore","year":"1996","journal-title":"Pharmaceut. Technol."},{"key":"ref_41","doi-asserted-by":"crossref","unstructured":"Shah, V.P., Lesko, L.J., Fan, J., Fleischer, N., Handerson, J., Malinowski, H., Makary, M., Duderkirk, L., Roy, S., and Sathe, P. (1997). FDA Guidance for industry dissolution testing of immediate release solid oral dosage forms. Dissolut. Technol., 15\u201322.","DOI":"10.14227\/DT040497P15"},{"key":"ref_42","doi-asserted-by":"crossref","first-page":"889","DOI":"10.1023\/A:1011976615750","article-title":"In vitro dissolution profile comparison\u2014Statistics and analysis of the similarity factor, f2","volume":"15","author":"Shah","year":"1998","journal-title":"Pharm. Res."},{"key":"ref_43","unstructured":"Birmingham, U. (2020, December 12). University of Birmingham\u2019s BlueBEAR HPC Service. Available online: http:\/\/www.birmingham.ac.uk.bear."},{"key":"ref_44","unstructured":"Ganzenm\u00fcller, G.C., Steinhauser, M.O., and Van Liedekerke, P. (2019, October 17). The Implementation of Smoothed Particle Hydrodynamics in LAMMPS, Available online: lammps.sandia.gov\/doc\/PDF\/SPH_LAMMPS_userguide.pdf."},{"key":"ref_45","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1006\/jcph.1995.1039","article-title":"Fast parallel algorithms for short-range molecular-dynamics","volume":"117","author":"Plimpton","year":"1995","journal-title":"J. Comput. Phys."},{"key":"ref_46","doi-asserted-by":"crossref","unstructured":"Stukowski, A. (2010). Visualization and analysis of atomistic simulation data with OVITO-the Open Visualization Tool. Modell. Simulat. Mater. Sci. Eng., 18.","DOI":"10.1088\/0965-0393\/18\/1\/015012"},{"key":"ref_47","unstructured":"Hinkle, B. (2020). Hatched fill patterns. MATLAB Central File Exchange, The MathWorks Inc."},{"key":"ref_48","unstructured":"MATLAB (2020). MATLAB 9.9.0.1495850 (R2020b), The MathWorks Inc."},{"key":"ref_49","doi-asserted-by":"crossref","first-page":"1215","DOI":"10.1007\/s11095-005-5272-x","article-title":"A novel in vitro and numerical analysis of shear-induced drug release from extended-release tablets in the fed stomach","volume":"22","author":"Abrahamsson","year":"2005","journal-title":"Pharm. Res."},{"key":"ref_50","doi-asserted-by":"crossref","first-page":"2956","DOI":"10.1002\/jps.24511","article-title":"Computational fluid dynamics simulation of hydrodynamics and stresses in the PhEur\/USP disintegration tester under fed and fasted fluid characteristics","volume":"104","author":"Kindgen","year":"2015","journal-title":"J. Pharm. Sci."},{"key":"ref_51","doi-asserted-by":"crossref","first-page":"3870","DOI":"10.1021\/acs.molpharmaceut.0c00614","article-title":"Hierarchical mass transfer analysis of drug particle dissolution, highlighting the hydrodynamics, pH, particle size, and buffer effects for the dissolution of ionizable and nonionizable drugs in a compendial dissolution vessel","volume":"17","author":"Salehi","year":"2020","journal-title":"Mol. Pharm."},{"key":"ref_52","doi-asserted-by":"crossref","first-page":"1911","DOI":"10.1016\/j.xphs.2018.03.019","article-title":"Using computational fluid dynamics to compare shear rate and turbulence in the TIM-automated gastric compartment with USP apparatus II","volume":"107","author":"Hopgood","year":"2018","journal-title":"J. Pharm. Sci."},{"key":"ref_53","doi-asserted-by":"crossref","first-page":"9","DOI":"10.1016\/j.ijpharm.2004.03.033","article-title":"Shear distribution and variability in the USP Apparatus 2 under turbulent conditions","volume":"279","author":"Kukura","year":"2004","journal-title":"Int. J. Pharm."},{"key":"ref_54","doi-asserted-by":"crossref","first-page":"17","DOI":"10.1016\/j.ijpharm.2004.08.003","article-title":"Hydrodynamics-induced variability in the USP apparatus II dissolution test","volume":"292","author":"Baxter","year":"2005","journal-title":"Int. J. Pharm."},{"key":"ref_55","doi-asserted-by":"crossref","first-page":"497","DOI":"10.1111\/j.1365-2036.1990.tb00496.x","article-title":"Pharmacokinetics of a 5-aminosalicylic acid enteric-coated tablet in patients with crohns-disease or ulcerative-colitis and in healthy-volunteers","volume":"4","author":"Norlander","year":"1990","journal-title":"Aliment. Pharmacol. Ther."},{"key":"ref_56","doi-asserted-by":"crossref","unstructured":"Effinger, A., O\u2019Driscoll, C.M., McAllister, M., and Fotaki, N. (2020). Gastrointestinal diseases and their impact on drug solubility: Crohn\u2019s disease. Eur. J. Pharm. Sci., 152.","DOI":"10.1016\/j.ejps.2020.105459"},{"key":"ref_57","doi-asserted-by":"crossref","unstructured":"Effinger, A., O\u2019Driscoll, C.M., McAllister, M., and Fotaki, N. (2020). Gastrointestinal diseases and their impact on drug solubility: Ulcerative colitis. Eur. J. Pharm. Sci., 152.","DOI":"10.1016\/j.ejps.2020.105458"},{"key":"ref_58","doi-asserted-by":"crossref","first-page":"155","DOI":"10.1046\/j.1365-2036.2000.00697.x","article-title":"Limited exposure of the healthy distal colon to orally-dosed formulation is further exaggerated in active left-sided ulcerative colitis","volume":"14","author":"Hebden","year":"2000","journal-title":"Aliment. Pharmacol. Ther."},{"key":"ref_59","first-page":"56","article-title":"Intestinal performance of two mesalamine formulations in patients with active ulcerative colitis as assessed by gamma scintigraphy","volume":"27","author":"Sinha","year":"2003","journal-title":"Pract. Gastroenterol."},{"key":"ref_60","doi-asserted-by":"crossref","first-page":"1193","DOI":"10.1111\/j.1365-2036.2009.03968.x","article-title":"A dynamic model of colonic concentrations of delayed-release 5-aminosalicylic acid (Asacol)","volume":"29","author":"Thorpe","year":"2009","journal-title":"Aliment. Pharmacol. Ther."}],"container-title":["Pharmaceutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1999-4923\/13\/6\/859\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T06:12:45Z","timestamp":1760163165000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1999-4923\/13\/6\/859"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,6,10]]},"references-count":60,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2021,6]]}},"alternative-id":["pharmaceutics13060859"],"URL":"https:\/\/doi.org\/10.3390\/pharmaceutics13060859","relation":{},"ISSN":["1999-4923"],"issn-type":[{"value":"1999-4923","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,6,10]]}}}