The DOI matches its Crossref record; 88 of the 88 references it cites were found in a registry or an index.
Physiological Parameters for Oral Delivery and in Vitro Testing
Open accessAbstract
Pharmaceutical solid oral dosage forms must undergo dissolution in the intestinal fluids of the gastrointestinal tract before they can be absorbed and reach the systemic circulation. Therefore, dissolution is a critical part of the drug-delivery process. The rate and extent of drug dissolution and absorption depend on the characteristics of the active ingredient as well as properties of the dosage form. Just as importantly, characteristics of the physiological environment such as buffer species, pH, bile salts, gastric emptying rate, intestinal motility, and hydrodynamics can significantly impact dissolution and absorption. While significant progress has been made since 1970 when the first compendial dissolution test was introduced (USP apparatus 1), current dissolution testing does not take full advantage of the extensive physiologic information that is available. For quality control purposes, where the question is one of lot-to-lot consistency in performance, using nonphysiologic test conditions that match drug and dosage form properties with practical dissolution media and apparatus may be appropriate. However, where in vitro-in vivo correlations are desired, it is logical to consider and utilize knowledge of the in vivo condition. This publication critically reviews the literature that is relevant to oral human drug delivery. Physiologically relevant information must serve as a basis for the design of dissolution test methods and systems that are more representative of the human condition. As in vitro methods advance in their physiological relevance, better in vitro-in vivo correlations will be possible. This will, in turn, lead to in vitro systems that can be utilized to more effectively design dosage forms that have improved and more consistent oral bioperformance.
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Cites
Goodman & Gilman's The Pharmacological Basis of Therapeutics
Brunton, L. L. (1985) · Cited by 7,321
Amidon, G. L., Lennernäs, H., Shah, V. P., & Crison, J. R. (1995) · Pharmaceutical Research · doi:10.1023/a:1016212804288 · Cited by 5,430
Self-citationMeasurement of gastrointestinal pH profiles in normal ambulant human subjects
Evans, D. F., Pye, G., Bramley, R., Clark, A. G., Dyson, T. J., & Hardcastle, J. D. (1988) · Gut · doi:10.1136/gut.29.8.1035 · Cited by 1,240
Dissolution Testing as a Prognostic Tool for Oral Drug Absorption: Immediate Release Dosage Forms
Dressman, J. B., Amidon, G. L., Reppas, C., & Shah, V. P. (1998) · Pharmaceutical Research · doi:10.1023/a:1011984216775 · Cited by 1,097
Self-citationStudies of Intestinal Digestion and Absorption in the Human1
Borgström, B., Dahlqvist, A., Lundh, G., & Sjövall, J. (1957) · Journal of Clinical Investigation · doi:10.1172/jci103549 · Cited by 1,048
Evaluation of Various Dissolution Media for Predicting In Vivo Performance of Class I and II Drugs
Galia, E., Nicolaides, E., Hörter, D., Löbenberg, R., Reppas, C., & Dressman, J. B. (1998) · Pharmaceutical Research · doi:10.1023/a:1011910801212 · Cited by 927
Transit of pharmaceutical dosage forms through the small intestine.
Davis, S. S., Hardy, J. G., & Fara, J. W. (1986) · Gut · doi:10.1136/gut.27.8.886 · Cited by 853
The colloidal domain: where physics, chemistry, biology, and technology meet
(1999) · Choice Reviews Online · doi:10.5860/choice.37-0334 · Cited by 821
Upper Gastrointestinal (GI) pH in Young, Healthy Men and Women
Dressman, J. B., Berardi, R. R., Dermentzoglou, L. C., Russell, T. L., Schmaltz, S. P., Barnett, J. L., & Jarvenpaa, K. M. (1990) · Pharmaceutical Research · doi:10.1023/a:1015827908309 · Cited by 775
Dissolution Media Simulating Conditions in the Proximal Human Gastrointestinal Tract: An Update
Jantratid, E., Janssen, N., Reppas, C., & Dressman, J. B. (2008) · Pharmaceutical Research · doi:10.1007/s11095-008-9569-4 · Cited by 764
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Challenges and Recent Progress in Oral Drug Delivery Systems for Biopharmaceuticals
Homayun, B., Lin, X., & Choi, H.-J. (2019) · Pharmaceutics · doi:10.3390/pharmaceutics11030129 · Cited by 837
Drug release study of the chitosan-based nanoparticles
Herdiana, Y., Wathoni, N., Shamsuddin, S., & Muchtaridi, M. (2022) · Heliyon · doi:10.1016/j.heliyon.2021.e08674 · Cited by 576
Mudie, D. M., Murray, K., Hoad, C. L., Pritchard, S. E., Garnett, M. C., Amidon, G. L., Gowland, P. A., Spiller, R. C., Amidon, G. E., & Marciani, L. (2014) · Molecular Pharmaceutics · doi:10.1021/mp500210c · Cited by 486
Self-citationHatton, G. B., Yadav, V., Basit, A. W., & Merchant, H. A. (2015) · Journal of Pharmaceutical Sciences · doi:10.1002/jps.24365 · Cited by 204
Miller, J. M., Beig, A., Krieg, B. J., Carr, R. A., Borchardt, T. B., Amidon, G. E., Amidon, G. L., & Dahan, A. (2011) · Molecular Pharmaceutics · doi:10.1021/mp200181v · Cited by 204
Self-citationSjögren, E., Westergren, J., Grant, I., Hanisch, G., Lindfors, L., Lennernäs, H., Abrahamsson, B., & Tannergren, C. (2013) · European Journal of Pharmaceutical Sciences · doi:10.1016/j.ejps.2013.05.019 · Cited by 168
Sjögren, E., Thörn, H., & Tannergren, C. (2016) · Molecular Pharmaceutics · doi:10.1021/acs.molpharmaceut.5b00861 · Cited by 98
Yu, A., Jackson, T., Tsume, Y., Koenigsknecht, M., Wysocki, J., Marciani, L., Amidon, G. L., Frances, A., Baker, J. R., Hasler, W., et al. (2017) · The AAPS Journal · doi:10.1208/s12248-017-0145-x · Cited by 30
Self-citation
Metadata
- Authors
- Mudie, D. M., Amidon, G. L., & Amidon, G. E.
- Venue
- Molecular Pharmaceutics
- Publisher
- American Chemical Society (ACS)
- Published
- 2010-09-07
- Volume
- 7
- Issue
- 5
- Pages
- 1388-1405
- ISSN
- 1543-8384 (ISSN-L)
- 1543-8392
- OpenAlex
- W2061742628
- Cited by
- 490
- References
- 88
- FWCI
- 8.63
- Type
- journal article
- Language
- en
- Open access
- green
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