Relative bioavailability of deferasirox tablets administered without dispersion and dispersed in various drinks.
Identifieur interne : 000A72 ( PubMed/Corpus ); précédent : 000A71; suivant : 000A73Relative bioavailability of deferasirox tablets administered without dispersion and dispersed in various drinks.
Auteurs : R. Séchaud ; C. Dutreix ; S. Balez ; F. Pommier ; T. Dumortier ; S. Morisson ; E. BrunSource :
- International journal of clinical pharmacology and therapeutics [ 0946-1965 ] ; 2008.
English descriptors
- KwdEn :
- Administration, Oral, Adult, Area Under Curve, Benzoates (blood), Benzoates (chemistry), Benzoates (pharmacokinetics), Beverages, Biological Availability, Chromatography, High Pressure Liquid, Citrus sinensis, Cross-Over Studies, Diarrhea (chemically induced), Drug Stability, Half-Life, Humans, Iron Chelating Agents (administration & dosage), Iron Chelating Agents (adverse effects), Iron Chelating Agents (pharmacokinetics), Male, Malus, Tablets, Tandem Mass Spectrometry, Triazoles (blood), Triazoles (chemistry), Triazoles (pharmacokinetics), Water (administration & dosage), Water (chemistry).
- MESH :
- chemical , administration & dosage : Iron Chelating Agents, Water.
- chemical , adverse effects : Iron Chelating Agents.
- chemical , blood : Benzoates, Triazoles.
- chemical , chemistry : Benzoates, Triazoles, Water.
- chemical , pharmacokinetics : Benzoates, Iron Chelating Agents, Triazoles.
- chemically induced : Diarrhea.
- Administration, Oral, Adult, Area Under Curve, Beverages, Biological Availability, Chromatography, High Pressure Liquid, Citrus sinensis, Cross-Over Studies, Drug Stability, Half-Life, Humans, Male, Malus, Tablets, Tandem Mass Spectrometry.
Abstract
Deferasirox (ExjadeA, ICL670) is a new, once-daily oral iron chelator, recently approved as first-line therapy in the treatment of iron overload resulting from blood transfusions. In registration studies, deferasirox tablets were dispersed in non-carbonated water prior to administration. In routine clinical practice, however, patients may prefer to take the tablet dispersed in a flavored drink rather than with water.
PubMed: 18218291
Links to Exploration step
pubmed:18218291Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Relative bioavailability of deferasirox tablets administered without dispersion and dispersed in various drinks.</title><author><name sortKey="Sechaud, R" sort="Sechaud, R" uniqKey="Sechaud R" first="R" last="Séchaud">R. Séchaud</name><affiliation><nlm:affiliation>Novartis Pharma AG, Basel, Switzerland. romain.sechaud@novartis.com</nlm:affiliation></affiliation></author><author><name sortKey="Dutreix, C" sort="Dutreix, C" uniqKey="Dutreix C" first="C" last="Dutreix">C. Dutreix</name></author><author><name sortKey="Balez, S" sort="Balez, S" uniqKey="Balez S" first="S" last="Balez">S. Balez</name></author><author><name sortKey="Pommier, F" sort="Pommier, F" uniqKey="Pommier F" first="F" last="Pommier">F. Pommier</name></author><author><name sortKey="Dumortier, T" sort="Dumortier, T" uniqKey="Dumortier T" first="T" last="Dumortier">T. Dumortier</name></author><author><name sortKey="Morisson, S" sort="Morisson, S" uniqKey="Morisson S" first="S" last="Morisson">S. Morisson</name></author><author><name sortKey="Brun, E" sort="Brun, E" uniqKey="Brun E" first="E" last="Brun">E. Brun</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2008">2008</date><idno type="RBID">pubmed:18218291</idno><idno type="pmid">18218291</idno><idno type="wicri:Area/PubMed/Corpus">000A72</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Relative bioavailability of deferasirox tablets administered without dispersion and dispersed in various drinks.</title><author><name sortKey="Sechaud, R" sort="Sechaud, R" uniqKey="Sechaud R" first="R" last="Séchaud">R. Séchaud</name><affiliation><nlm:affiliation>Novartis Pharma AG, Basel, Switzerland. romain.sechaud@novartis.com</nlm:affiliation></affiliation></author><author><name sortKey="Dutreix, C" sort="Dutreix, C" uniqKey="Dutreix C" first="C" last="Dutreix">C. Dutreix</name></author><author><name sortKey="Balez, S" sort="Balez, S" uniqKey="Balez S" first="S" last="Balez">S. Balez</name></author><author><name sortKey="Pommier, F" sort="Pommier, F" uniqKey="Pommier F" first="F" last="Pommier">F. Pommier</name></author><author><name sortKey="Dumortier, T" sort="Dumortier, T" uniqKey="Dumortier T" first="T" last="Dumortier">T. Dumortier</name></author><author><name sortKey="Morisson, S" sort="Morisson, S" uniqKey="Morisson S" first="S" last="Morisson">S. Morisson</name></author><author><name sortKey="Brun, E" sort="Brun, E" uniqKey="Brun E" first="E" last="Brun">E. Brun</name></author></analytic><series><title level="j">International journal of clinical pharmacology and therapeutics</title><idno type="ISSN">0946-1965</idno><imprint><date when="2008" type="published">2008</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Administration, Oral</term><term>Adult</term><term>Area Under Curve</term><term>Benzoates (blood)</term><term>Benzoates (chemistry)</term><term>Benzoates (pharmacokinetics)</term><term>Beverages</term><term>Biological Availability</term><term>Chromatography, High Pressure Liquid</term><term>Citrus sinensis</term><term>Cross-Over Studies</term><term>Diarrhea (chemically induced)</term><term>Drug Stability</term><term>Half-Life</term><term>Humans</term><term>Iron Chelating Agents (administration & dosage)</term><term>Iron Chelating Agents (adverse effects)</term><term>Iron Chelating Agents (pharmacokinetics)</term><term>Male</term><term>Malus</term><term>Tablets</term><term>Tandem Mass Spectrometry</term><term>Triazoles (blood)</term><term>Triazoles (chemistry)</term><term>Triazoles (pharmacokinetics)</term><term>Water (administration & dosage)</term><term>Water (chemistry)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Iron Chelating Agents</term><term>Water</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Iron Chelating Agents</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Benzoates</term><term>Triazoles</term></keywords><keywords scheme="MESH" type="chemical" qualifier="chemistry" xml:lang="en"><term>Benzoates</term><term>Triazoles</term><term>Water</term></keywords><keywords scheme="MESH" type="chemical" qualifier="pharmacokinetics" xml:lang="en"><term>Benzoates</term><term>Iron Chelating Agents</term><term>Triazoles</term></keywords><keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Diarrhea</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Administration, Oral</term><term>Adult</term><term>Area Under Curve</term><term>Beverages</term><term>Biological Availability</term><term>Chromatography, High Pressure Liquid</term><term>Citrus sinensis</term><term>Cross-Over Studies</term><term>Drug Stability</term><term>Half-Life</term><term>Humans</term><term>Male</term><term>Malus</term><term>Tablets</term><term>Tandem Mass Spectrometry</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Deferasirox (ExjadeA, ICL670) is a new, once-daily oral iron chelator, recently approved as first-line therapy in the treatment of iron overload resulting from blood transfusions. In registration studies, deferasirox tablets were dispersed in non-carbonated water prior to administration. In routine clinical practice, however, patients may prefer to take the tablet dispersed in a flavored drink rather than with water.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">18218291</PMID><DateCreated><Year>2008</Year><Month>1</Month><Day>25</Day></DateCreated><DateCompleted><Year>2008</Year><Month>05</Month><Day>22</Day></DateCompleted><DateRevised><Year>2013</Year><Month>11</Month><Day>21</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">0946-1965</ISSN><JournalIssue CitedMedium="Print"><Volume>46</Volume><Issue>2</Issue><PubDate><Year>2008</Year><Month>Feb</Month></PubDate></JournalIssue><Title>International journal of clinical pharmacology and therapeutics</Title><ISOAbbreviation>Int J Clin Pharmacol Ther</ISOAbbreviation></Journal><ArticleTitle>Relative bioavailability of deferasirox tablets administered without dispersion and dispersed in various drinks.</ArticleTitle><Pagination><MedlinePgn>102-8</MedlinePgn></Pagination><Abstract><AbstractText Label="UNLABELLED">Deferasirox (ExjadeA, ICL670) is a new, once-daily oral iron chelator, recently approved as first-line therapy in the treatment of iron overload resulting from blood transfusions. In registration studies, deferasirox tablets were dispersed in non-carbonated water prior to administration. In routine clinical practice, however, patients may prefer to take the tablet dispersed in a flavored drink rather than with water.</AbstractText><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">Stability and compatibility tests were performed to identify beverages suitable for the dispersion of tablets for further testing in man. This was followed by a pharmacokinetic study to assess the relative bioavailability of deferasirox tablets dispersed in two types of soft drinks, dispersed in water, and without dispersion.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">An open-label, randomized, 4-period, crossover study was carried out with 28 healthy volunteers who received single 20 mg/kg oral doses of deferasirox without dispersion, dispersed in orange juice, dispersed in apple juice and dispersed in non-carbonated water (reference). Deferasirox and Fe-[deferasirox]2 were measured in plasma using liquid chromatography-mass spectrometry. Pharmacokinetic parameters were compared using standard bioequivalence tests.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Mean deferasirox AUC0-t were 1,040 A+/- 530, 1,010 A+/- 278, 882 A+/- 252 and 996 A+/- 352 h x micromol/l when deferasirox tablets were administered without dispersion, dispersed in orange juice, dispersed in apple juice and dispersed in water, respectively, indicating that these forms of deferasirox administrations met bioequivalence criteria. Therefore, the oral bioavailability of deferasirox tablets was not affected neither by the degree of dispersion nor by the type of drink (orange or apple juice versus water) used for dispersion.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">This study shows that deferasirox bioavailability is unaltered when dispersed with orange or apple juice compared with dispersion in water. Thus, in addition to water, patients have the option of taking deferasirox tablets in orange or apple juice. The degree of dispersion did not affect deferasirox bioavailability. Therefore, deferasirox therapy will not be compromised if dispersion of the tablet is not fully complete; although the latter should be avoided.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Séchaud</LastName><ForeName>R</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Novartis Pharma AG, Basel, Switzerland. romain.sechaud@novartis.com</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dutreix</LastName><ForeName>C</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Balez</LastName><ForeName>S</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Pommier</LastName><ForeName>F</ForeName><Initials>F</Initials></Author><Author ValidYN="Y"><LastName>Dumortier</LastName><ForeName>T</ForeName><Initials>T</Initials></Author><Author ValidYN="Y"><LastName>Morisson</LastName><ForeName>S</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Brun</LastName><ForeName>E</ForeName><Initials>E</Initials></Author></AuthorList><Language>ENG</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>Germany</Country><MedlineTA>Int J Clin Pharmacol Ther</MedlineTA><NlmUniqueID>9423309</NlmUniqueID><ISSNLinking>0946-1965</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D001565">Benzoates</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007502">Iron Chelating Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D013607">Tablets</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D014230">Triazoles</NameOfSubstance></Chemical><Chemical><RegistryNumber>059QF0KO0R</RegistryNumber><NameOfSubstance UI="D014867">Water</NameOfSubstance></Chemical><Chemical><RegistryNumber>V8G4MOF2V9</RegistryNumber><NameOfSubstance UI="C415250">deferasirox</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000284" MajorTopicYN="N">Administration, Oral</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D019540" MajorTopicYN="N">Area Under Curve</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D001565" MajorTopicYN="N">Benzoates</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName><QualifierName UI="Q000737" MajorTopicYN="N">chemistry</QualifierName><QualifierName UI="Q000493" MajorTopicYN="Y">pharmacokinetics</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D001628" MajorTopicYN="Y">Beverages</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D001682" MajorTopicYN="N">Biological Availability</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002851" MajorTopicYN="N">Chromatography, High Pressure Liquid</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D032084" MajorTopicYN="N">Citrus sinensis</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D018592" MajorTopicYN="N">Cross-Over Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D003967" MajorTopicYN="N">Diarrhea</DescriptorName><QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004355" MajorTopicYN="N">Drug Stability</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006207" MajorTopicYN="N">Half-Life</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007502" MajorTopicYN="N">Iron Chelating Agents</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000493" MajorTopicYN="N">pharmacokinetics</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D027845" MajorTopicYN="N">Malus</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013607" MajorTopicYN="N">Tablets</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D053719" MajorTopicYN="N">Tandem Mass Spectrometry</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014230" 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