An in vitro-in vivo correlation study for nifedipine immediate release capsules administered with water, alcoholic and non-alcoholic beverages: Impact of in vitro dissolution media and hydrodynamics.
Identifieur interne : 000070 ( PubMed/Corpus ); précédent : 000069; suivant : 000071An in vitro-in vivo correlation study for nifedipine immediate release capsules administered with water, alcoholic and non-alcoholic beverages: Impact of in vitro dissolution media and hydrodynamics.
Auteurs : A. Mercuri ; R. Fares ; M. Bresciani ; N. FotakiSource :
- International journal of pharmaceutics [ 1873-3476 ] ; 2016.
English descriptors
- KwdEn :
- Administration, Oral, Alcoholic Beverages, Calcium Channel Blockers (administration & dosage), Calcium Channel Blockers (chemistry), Capsules, Citrus sinensis, Drug Liberation, Food-Drug Interactions, Fruit and Vegetable Juices, Gastric Juice (metabolism), Hydrodynamics, Hydrogen-Ion Concentration, Nifedipine (administration & dosage), Nifedipine (chemistry), Solubility, Water (administration & dosage).
- MESH :
- chemical , administration & dosage : Calcium Channel Blockers, Nifedipine, Water.
- chemical , chemistry : Calcium Channel Blockers, Nifedipine.
- metabolism : Gastric Juice.
- Administration, Oral, Alcoholic Beverages, Capsules, Citrus sinensis, Drug Liberation, Food-Drug Interactions, Fruit and Vegetable Juices, Hydrodynamics, Hydrogen-Ion Concentration, Solubility.
Abstract
The impact of hydrodynamics and media composition on nifedipine dissolution profile from IR (immediate release) soft capsules was investigated using dissolution apparatus USP1, USP2, USP3 and USP4 (United State Pharmacopoeia). Media composition was varied in terms of pH and content, to mimic the dosage form intake with water or non-alcoholic beverages (orange juice) and alcoholic beverages (orange juice/ethanol mixture (47% v/v)). Through construction of in vitro-in vivo correlations (IVIVC) with corresponding in vivo data from the literature, it was possible to evaluate the in vitro conditions that are likely to simulate the in vivo formulation behaviour. Both linear and nonlinear correlations were obtained depending on experimental set-ups. Testing of 20mg nifedipine capsules in FaSSGFst (Fasted State Simulated Gastric Fluid pH 1.6; water administration) produced IVIVC with the USP3 (after time scaling) and USP4 apparatus. IVIVC were obtained for USP2, USP3 and USP4 in FaSSGFoj (Fasted State Simulated Gastric Fluid pH 3.4; orange juice administration). Linear and nonlinear correlations were obtained with the USP1, USP2 and USP3 apparatus when testing the capsules in FaSSGFoj/EtOH (orange juice/ethanol administration). This study highlighted that selection of physiologically relevant dissolution set-ups is critical for predicting the in vivo impact of formulations co-administration with water, non-alcoholic and alcoholic beverages.
DOI: 10.1016/j.ijpharm.2015.12.047
PubMed: 26721731
Links to Exploration step
pubmed:26721731Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">An in vitro-in vivo correlation study for nifedipine immediate release capsules administered with water, alcoholic and non-alcoholic beverages: Impact of in vitro dissolution media and hydrodynamics.</title><author><name sortKey="Mercuri, A" sort="Mercuri, A" uniqKey="Mercuri A" first="A" last="Mercuri">A. Mercuri</name><affiliation><nlm:affiliation>Research Center Pharmaceutical Engineering GmbH, Graz, Austria.</nlm:affiliation></affiliation></author><author><name sortKey="Fares, R" sort="Fares, R" uniqKey="Fares R" first="R" last="Fares">R. Fares</name><affiliation><nlm:affiliation>Research Center Pharmaceutical Engineering GmbH, Graz, Austria; Department of Pharmacy and Pharmacology, University of Bath, Bath, United Kingdom.</nlm:affiliation></affiliation></author><author><name sortKey="Bresciani, M" sort="Bresciani, M" uniqKey="Bresciani M" first="M" last="Bresciani">M. Bresciani</name><affiliation><nlm:affiliation>Research Center Pharmaceutical Engineering GmbH, Graz, Austria.</nlm:affiliation></affiliation></author><author><name sortKey="Fotaki, N" sort="Fotaki, N" uniqKey="Fotaki N" first="N" last="Fotaki">N. Fotaki</name><affiliation><nlm:affiliation>Department of Pharmacy and Pharmacology, University of Bath, Bath, United Kingdom. Electronic address: n.fotaki@bath.ac.uk.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2016">2016</date><idno type="RBID">pubmed:26721731</idno><idno type="pmid">26721731</idno><idno type="doi">10.1016/j.ijpharm.2015.12.047</idno><idno type="wicri:Area/PubMed/Corpus">000070</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">An in vitro-in vivo correlation study for nifedipine immediate release capsules administered with water, alcoholic and non-alcoholic beverages: Impact of in vitro dissolution media and hydrodynamics.</title><author><name sortKey="Mercuri, A" sort="Mercuri, A" uniqKey="Mercuri A" first="A" last="Mercuri">A. Mercuri</name><affiliation><nlm:affiliation>Research Center Pharmaceutical Engineering GmbH, Graz, Austria.</nlm:affiliation></affiliation></author><author><name sortKey="Fares, R" sort="Fares, R" uniqKey="Fares R" first="R" last="Fares">R. Fares</name><affiliation><nlm:affiliation>Research Center Pharmaceutical Engineering GmbH, Graz, Austria; Department of Pharmacy and Pharmacology, University of Bath, Bath, United Kingdom.</nlm:affiliation></affiliation></author><author><name sortKey="Bresciani, M" sort="Bresciani, M" uniqKey="Bresciani M" first="M" last="Bresciani">M. Bresciani</name><affiliation><nlm:affiliation>Research Center Pharmaceutical Engineering GmbH, Graz, Austria.</nlm:affiliation></affiliation></author><author><name sortKey="Fotaki, N" sort="Fotaki, N" uniqKey="Fotaki N" first="N" last="Fotaki">N. Fotaki</name><affiliation><nlm:affiliation>Department of Pharmacy and Pharmacology, University of Bath, Bath, United Kingdom. Electronic address: n.fotaki@bath.ac.uk.</nlm:affiliation></affiliation></author></analytic><series><title level="j">International journal of pharmaceutics</title><idno type="eISSN">1873-3476</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Administration, Oral</term><term>Alcoholic Beverages</term><term>Calcium Channel Blockers (administration & dosage)</term><term>Calcium Channel Blockers (chemistry)</term><term>Capsules</term><term>Citrus sinensis</term><term>Drug Liberation</term><term>Food-Drug Interactions</term><term>Fruit and Vegetable Juices</term><term>Gastric Juice (metabolism)</term><term>Hydrodynamics</term><term>Hydrogen-Ion Concentration</term><term>Nifedipine (administration & dosage)</term><term>Nifedipine (chemistry)</term><term>Solubility</term><term>Water (administration & dosage)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Calcium Channel Blockers</term><term>Nifedipine</term><term>Water</term></keywords><keywords scheme="MESH" type="chemical" qualifier="chemistry" xml:lang="en"><term>Calcium Channel Blockers</term><term>Nifedipine</term></keywords><keywords scheme="MESH" qualifier="metabolism" xml:lang="en"><term>Gastric Juice</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Administration, Oral</term><term>Alcoholic Beverages</term><term>Capsules</term><term>Citrus sinensis</term><term>Drug Liberation</term><term>Food-Drug Interactions</term><term>Fruit and Vegetable Juices</term><term>Hydrodynamics</term><term>Hydrogen-Ion Concentration</term><term>Solubility</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The impact of hydrodynamics and media composition on nifedipine dissolution profile from IR (immediate release) soft capsules was investigated using dissolution apparatus USP1, USP2, USP3 and USP4 (United State Pharmacopoeia). Media composition was varied in terms of pH and content, to mimic the dosage form intake with water or non-alcoholic beverages (orange juice) and alcoholic beverages (orange juice/ethanol mixture (47% v/v)). Through construction of in vitro-in vivo correlations (IVIVC) with corresponding in vivo data from the literature, it was possible to evaluate the in vitro conditions that are likely to simulate the in vivo formulation behaviour. Both linear and nonlinear correlations were obtained depending on experimental set-ups. Testing of 20mg nifedipine capsules in FaSSGFst (Fasted State Simulated Gastric Fluid pH 1.6; water administration) produced IVIVC with the USP3 (after time scaling) and USP4 apparatus. IVIVC were obtained for USP2, USP3 and USP4 in FaSSGFoj (Fasted State Simulated Gastric Fluid pH 3.4; orange juice administration). Linear and nonlinear correlations were obtained with the USP1, USP2 and USP3 apparatus when testing the capsules in FaSSGFoj/EtOH (orange juice/ethanol administration). This study highlighted that selection of physiologically relevant dissolution set-ups is critical for predicting the in vivo impact of formulations co-administration with water, non-alcoholic and alcoholic beverages.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26721731</PMID><DateCreated><Year>2016</Year><Month>2</Month><Day>5</Day></DateCreated><DateCompleted><Year>2016</Year><Month>10</Month><Day>31</Day></DateCompleted><DateRevised><Year>2016</Year><Month>11</Month><Day>1</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1873-3476</ISSN><JournalIssue CitedMedium="Internet"><Volume>499</Volume><Issue>1-2</Issue><PubDate><Year>2016</Year><Month>Feb</Month><Day>29</Day></PubDate></JournalIssue><Title>International journal of pharmaceutics</Title><ISOAbbreviation>Int J Pharm</ISOAbbreviation></Journal><ArticleTitle>An in vitro-in vivo correlation study for nifedipine immediate release capsules administered with water, alcoholic and non-alcoholic beverages: Impact of in vitro dissolution media and hydrodynamics.</ArticleTitle><Pagination><MedlinePgn>330-42</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.ijpharm.2015.12.047</ELocationID><ELocationID EIdType="pii" ValidYN="Y">S0378-5173(15)30452-X</ELocationID><Abstract><AbstractText>The impact of hydrodynamics and media composition on nifedipine dissolution profile from IR (immediate release) soft capsules was investigated using dissolution apparatus USP1, USP2, USP3 and USP4 (United State Pharmacopoeia). Media composition was varied in terms of pH and content, to mimic the dosage form intake with water or non-alcoholic beverages (orange juice) and alcoholic beverages (orange juice/ethanol mixture (47% v/v)). Through construction of in vitro-in vivo correlations (IVIVC) with corresponding in vivo data from the literature, it was possible to evaluate the in vitro conditions that are likely to simulate the in vivo formulation behaviour. Both linear and nonlinear correlations were obtained depending on experimental set-ups. Testing of 20mg nifedipine capsules in FaSSGFst (Fasted State Simulated Gastric Fluid pH 1.6; water administration) produced IVIVC with the USP3 (after time scaling) and USP4 apparatus. IVIVC were obtained for USP2, USP3 and USP4 in FaSSGFoj (Fasted State Simulated Gastric Fluid pH 3.4; orange juice administration). Linear and nonlinear correlations were obtained with the USP1, USP2 and USP3 apparatus when testing the capsules in FaSSGFoj/EtOH (orange juice/ethanol administration). This study highlighted that selection of physiologically relevant dissolution set-ups is critical for predicting the in vivo impact of formulations co-administration with water, non-alcoholic and alcoholic beverages.</AbstractText><CopyrightInformation>Copyright © 2015 Elsevier B.V. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Mercuri</LastName><ForeName>A</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Research Center Pharmaceutical Engineering GmbH, Graz, Austria.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fares</LastName><ForeName>R</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Research Center Pharmaceutical Engineering GmbH, Graz, Austria; Department of Pharmacy and Pharmacology, University of Bath, Bath, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bresciani</LastName><ForeName>M</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Research Center Pharmaceutical Engineering GmbH, Graz, Austria.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fotaki</LastName><ForeName>N</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Department of Pharmacy and Pharmacology, University of Bath, Bath, United Kingdom. Electronic address: n.fotaki@bath.ac.uk.</Affiliation></AffiliationInfo></Author></AuthorList><Language>ENG</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>Dec</Month><Day>22</Day></ArticleDate></Article><MedlineJournalInfo><Country>Netherlands</Country><MedlineTA>Int J Pharm</MedlineTA><NlmUniqueID>7804127</NlmUniqueID><ISSNLinking>0378-5173</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D002121">Calcium Channel Blockers</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D002214">Capsules</NameOfSubstance></Chemical><Chemical><RegistryNumber>059QF0KO0R</RegistryNumber><NameOfSubstance UI="D014867">Water</NameOfSubstance></Chemical><Chemical><RegistryNumber>I9ZF7L6G2L</RegistryNumber><NameOfSubstance UI="D009543">Nifedipine</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000284" MajorTopicYN="N">Administration, Oral</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000434" MajorTopicYN="N">Alcoholic Beverages</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002121" MajorTopicYN="N">Calcium Channel Blockers</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000737" MajorTopicYN="N">chemistry</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002214" MajorTopicYN="N">Capsules</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D032084" MajorTopicYN="N">Citrus sinensis</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D065546" MajorTopicYN="N">Drug Liberation</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D018565" MajorTopicYN="Y">Food-Drug Interactions</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000067030" MajorTopicYN="N">Fruit and Vegetable Juices</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005750" MajorTopicYN="N">Gastric Juice</DescriptorName><QualifierName UI="Q000378" MajorTopicYN="Y">metabolism</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D057446" MajorTopicYN="N">Hydrodynamics</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006863" MajorTopicYN="N">Hydrogen-Ion Concentration</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009543" MajorTopicYN="N">Nifedipine</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000737" MajorTopicYN="N">chemistry</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012995" MajorTopicYN="N">Solubility</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014867" MajorTopicYN="N">Water</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Alcoholic beverages</Keyword><Keyword MajorTopicYN="N">Biorelevant dissolution</Keyword><Keyword MajorTopicYN="N">Capsule rupture time</Keyword><Keyword MajorTopicYN="N">Hydrodynamics</Keyword><Keyword MajorTopicYN="N">IVIVC</Keyword><Keyword MajorTopicYN="N">Immediate release</Keyword><Keyword MajorTopicYN="N">Nifedipine</Keyword><Keyword MajorTopicYN="N">Nifedipine (PubChem CID: 4485)</Keyword><Keyword MajorTopicYN="N">Non-alcoholic beverages</Keyword><Keyword MajorTopicYN="N">Special dissolution media</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2015</Year><Month>11</Month><Day>13</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2015</Year><Month>12</Month><Day>16</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2015</Year><Month>12</Month><Day>18</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2016</Year><Month>1</Month><Day>2</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2016</Year><Month>1</Month><Day>2</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2016</Year><Month>11</Month><Day>1</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">26721731</ArticleId><ArticleId IdType="pii">S0378-5173(15)30452-X</ArticleId><ArticleId IdType="doi">10.1016/j.ijpharm.2015.12.047</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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