Linked Life Data

11961894

Source:http://linkedlifedata.com/resource/pubmed/id/11961894

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
3
pubmed:dateCreated
2002-4-18
pubmed:abstractText
Drug dissolution is a prerequisite to drug absorption and in vivo effectiveness for almost all drugs given in oral solid dosage forms. Drug absorption depends on the dissolution and solubilization of the drug under physiological conditions, and the permeability across the gastrointestinal tract. Because of the critical nature of the first steps, in vitro dissolution may be relevant to the prediction of biological response. Dissolution tests are applied to choose between formulation factors, assess the lot-to-lot quality of a drug product according to the biobatch; and ensure continuing product quality and performance after certain changes (e.g. in the formulation and manufacturing process, site of manufacture, scale-up). The recently developed Biopharmaceutical Classification System (BCS) has several benefits for recognizing how dissolution tests can be designed and which physiological factors have to be taken into consideration for the in vitro evaluation of solid dosage forms. Choice of test conditions (composition, volume and hydrodynamics of dissolution medium) should be based on where the drug is best absorbed in the gastrointestinal tract, and on whether it is administered in fasted or fed state. Duration of test and physiologically representative media can be selected to simulate gastric and intestinal environments according to the permeability profile of the drug, but mimicking in vivo hydrodynamics remains problematic and further research is required. To provide a basis for predicting the likelihood of achieving a successful in vivo-in vitro correlation, this review summarizes the biopharmaceutical considerations of in vivo drug release in accordance with the BCS.
pubmed:language
hun
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Oct
pubmed:issn
0001-6659
pubmed:author
pubmed:issnType
Print
pubmed:volume
71
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
280-8
pubmed:dateRevised
2006-11-15
pubmed:meshHeading
pubmed:year
2001
pubmed:articleTitle
[Biopharmaceutical considerations of dissolution testing used as a prognostic tool for oral drug adsorption].
pubmed:affiliation
Gyógyszerészeti Intézet, Budapest.
pubmed:publicationType
Journal Article, English Abstract