Drug Dissolution in Oral Drug Absorption: Workshop Report.

Humans Drug Liberation Solubility Intestinal Absorption Biopharmaceutics Water

absorption amorphous dissolution food permeability solubility

Journal

The AAPS journal

ISSN: 1550-7416

Titre abrégé: AAPS J

Pays: United States

ID NLM: 101223209

Informations de publication

Date de publication:
07 11 2023

Historique:

received: 07 09 2023

accepted: 02 10 2023

medline: 9 11 2023

pubmed: 8 11 2023

entrez: 7 11 2023

Statut: epublish

Résumé

The in-person workshop "Drug Dissolution in Oral Drug Absorption" was held on May 23-24, 2023, in Baltimore, MD, USA. The workshop was organized into lectures and breakout sessions. Three common topics that were re-visited by various lecturers were amorphous solid dispersions (ASDs), dissolution/permeation interplay, and in vitro methods to predict in vivo biopharmaceutics performance and risk. Topics that repeatedly surfaced across breakout sessions were the following: (1) meaning and assessment of "dissolved drug," particularly of poorly water soluble drug in colloidal environments (e.g., fed conditions, ASDs); (2) potential limitations of a test that employs sink conditions for a poorly water soluble drug; (3) non-compendial methods (e.g., two-stage or multi-stage method, dissolution/permeation methods); (4) non-compendial conditions (e.g., apex vessels, non-sink conditions); and (5) potential benefit of having both a quality control method for batch release and a biopredictive/biorelevant method for biowaiver or bridging scenarios. An identified obstacle to non-compendial methods is the uncertainty of global regulatory acceptance of such methods.

Identifiants

DOI: 10.1208/s12248-023-00865-8 PMID: 37936002

pubmed: 37936002

doi: 10.1208/s12248-023-00865-8

pii: 10.1208/s12248-023-00865-8

doi:

Substances chimiques

Water 059QF0KO0R

Types de publication

Journal Article Research Support, U.S. Gov't, P.H.S.

Langues

eng

Sous-ensembles de citation

Pagination

103

Informations de copyright

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