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Cited by 490

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 access
Mudie, Deanna M., Amidon, Gordon L., Amidon, Gregory E.·2010·Molecular Pharmaceutics
DOI 10.1021/mp100149j
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Abstract

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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Crossref · 10.1021/mp100149j

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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
DOI
10.1021/mp100149j
OpenAlex
W2061742628
Cited by
490
References
88
FWCI
8.63
Type
journal article
Language
en
Open access
green

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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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