The disintegration behaviour of capsules in fed subjects: a comparison of hypromellose (carrageenan) capsules and standard gelatin capsules.
Identifieur interne : 000992 ( Main/Exploration ); précédent : 000991; suivant : 000993The disintegration behaviour of capsules in fed subjects: a comparison of hypromellose (carrageenan) capsules and standard gelatin capsules.
Auteurs : RBID : pubmed:22214655English descriptors
- KwdEn :
- Administration, Oral, Adult, Capsules, Carrageenan (pharmacokinetics), Drug Carriers (pharmacokinetics), Fasting (metabolism), Gelatin (pharmacokinetics), Humans, Indium Radioisotopes (diagnostic use), Male, Methylcellulose (analogs & derivatives), Methylcellulose (pharmacokinetics), Single-Blind Method, Stomach (metabolism), Stomach (radionuclide imaging), Technetium Tc 99m Pentetate (diagnostic use), Young Adult.
- MESH :
- chemical , analogs & derivatives : Methylcellulose.
- chemical , diagnostic use : Indium Radioisotopes, Technetium Tc 99m Pentetate.
- chemical , pharmacokinetics : Carrageenan, Drug Carriers, Gelatin, Methylcellulose.
- chemical : Capsules.
- metabolism : Fasting, Stomach.
- radionuclide imaging : Stomach.
- Administration, Oral, Adult, Humans, Male, Single-Blind Method, Young Adult.
Abstract
Two-piece hard shell capsules made from hypromellose (or hydroxypropyl methylcellulose, HPMC) containing carrageenan as a gelling agent have been proposed as an alternative to conventional gelatin capsules for oral drug delivery. We have previously compared the disintegration of hypromellose(carrageenan) (Quali-V(®)) and gelatin capsules (Qualicaps) in fasted human subjects using the technique of gamma scintigraphy. This second study used the same technique with both fasted and fed human subjects. Size 0 capsules were filled with powder plugs made from lactose and did not contain croscarmellose as in the original study. The capsules were separately radiolabelled with indium-111 and technetium-99m. Both capsules were administered simultaneously with 180ml water to eight healthy male subjects following an overnight fast. Each volunteer was positioned in front of the gamma camera and sequential 60s images were acquired in a continuous manner for 30min. The mean (±S.D.) disintegration time in the fasted state for the hypromellose(carrageenan) capsules was 8±2min and for gelatin 7±3min. These results were not statistically different from the data in the original study and show that the removal of the croscarmellose had no effect on the results. The mean (±S.D.) disintegration time in the fed state for the hypromellose(carrageenan) capsules was 16±5min and for the gelatin capsules was 12±4min. There was no statistical difference between the hypromellose(carrageenan) and gelatin capsules in either the fed or fasted state.
DOI: 10.1016/j.ijpharm.2011.12.034
PubMed: 22214655
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We have previously compared the disintegration of hypromellose(carrageenan) (Quali-V(®)) and gelatin capsules (Qualicaps) in fasted human subjects using the technique of gamma scintigraphy. This second study used the same technique with both fasted and fed human subjects. Size 0 capsules were filled with powder plugs made from lactose and did not contain croscarmellose as in the original study. The capsules were separately radiolabelled with indium-111 and technetium-99m. Both capsules were administered simultaneously with 180ml water to eight healthy male subjects following an overnight fast. Each volunteer was positioned in front of the gamma camera and sequential 60s images were acquired in a continuous manner for 30min. The mean (±S.D.) disintegration time in the fasted state for the hypromellose(carrageenan) capsules was 8±2min and for gelatin 7±3min. These results were not statistically different from the data in the original study and show that the removal of the croscarmellose had no effect on the results. The mean (±S.D.) disintegration time in the fed state for the hypromellose(carrageenan) capsules was 16±5min and for the gelatin capsules was 12±4min. There was no statistical difference between the hypromellose(carrageenan) and gelatin capsules in either the fed or fasted state.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">22214655</PMID><DateCreated><Year>2012</Year><Month>02</Month><Day>13</Day></DateCreated><DateCompleted><Year>2012</Year><Month>07</Month><Day>02</Day></DateCompleted><DateRevised><Year>2013</Year><Month>11</Month><Day>21</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1873-3476</ISSN><JournalIssue CitedMedium="Internet"><Volume>424</Volume><Issue>1-2</Issue><PubDate><Year>2012</Year><Month>Mar</Month><Day>15</Day></PubDate></JournalIssue><Title>International journal of pharmaceutics</Title><ISOAbbreviation>Int J Pharm</ISOAbbreviation></Journal><ArticleTitle>The disintegration behaviour of capsules in fed subjects: a comparison of hypromellose (carrageenan) capsules and standard gelatin capsules.</ArticleTitle><Pagination><MedlinePgn>40-3</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.ijpharm.2011.12.034</ELocationID><Abstract><AbstractText>Two-piece hard shell capsules made from hypromellose (or hydroxypropyl methylcellulose, HPMC) containing carrageenan as a gelling agent have been proposed as an alternative to conventional gelatin capsules for oral drug delivery. We have previously compared the disintegration of hypromellose(carrageenan) (Quali-V(®)) and gelatin capsules (Qualicaps) in fasted human subjects using the technique of gamma scintigraphy. This second study used the same technique with both fasted and fed human subjects. Size 0 capsules were filled with powder plugs made from lactose and did not contain croscarmellose as in the original study. The capsules were separately radiolabelled with indium-111 and technetium-99m. Both capsules were administered simultaneously with 180ml water to eight healthy male subjects following an overnight fast. Each volunteer was positioned in front of the gamma camera and sequential 60s images were acquired in a continuous manner for 30min. The mean (±S.D.) disintegration time in the fasted state for the hypromellose(carrageenan) capsules was 8±2min and for gelatin 7±3min. These results were not statistically different from the data in the original study and show that the removal of the croscarmellose had no effect on the results. The mean (±S.D.) disintegration time in the fed state for the hypromellose(carrageenan) capsules was 16±5min and for the gelatin capsules was 12±4min. There was no statistical difference between the hypromellose(carrageenan) and gelatin capsules in either the fed or fasted state.</AbstractText><CopyrightInformation>Copyright © 2012 Elsevier B.V. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Jones</LastName><ForeName>B E</ForeName><Initials>BE</Initials><Affiliation>Qualicaps Europe, S.A.U., 28108 Alcobendas, Madrid, Spain.</Affiliation></Author><Author ValidYN="Y"><LastName>Basit</LastName><ForeName>A W</ForeName><Initials>AW</Initials></Author><Author ValidYN="Y"><LastName>Tuleu</LastName><ForeName>C</ForeName><Initials>C</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType>Clinical Trial</PublicationType><PublicationType>Comparative Study</PublicationType><PublicationType>Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2011</Year><Month>12</Month><Day>28</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>Capsules</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance>Drug Carriers</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance>Indium Radioisotopes</NameOfSubstance></Chemical><Chemical><RegistryNumber>8063-82-9</RegistryNumber><NameOfSubstance>hypromellose</NameOfSubstance></Chemical><Chemical><RegistryNumber>9000-07-1</RegistryNumber><NameOfSubstance>Carrageenan</NameOfSubstance></Chemical><Chemical><RegistryNumber>9000-70-8</RegistryNumber><NameOfSubstance>Gelatin</NameOfSubstance></Chemical><Chemical><RegistryNumber>9004-67-5</RegistryNumber><NameOfSubstance>Methylcellulose</NameOfSubstance></Chemical><Chemical><RegistryNumber>VW78417PU1</RegistryNumber><NameOfSubstance>Technetium Tc 99m Pentetate</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N">Administration, Oral</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N">Capsules</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N">Carrageenan</DescriptorName><QualifierName MajorTopicYN="Y">pharmacokinetics</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N">Drug Carriers</DescriptorName><QualifierName MajorTopicYN="Y">pharmacokinetics</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N">Fasting</DescriptorName><QualifierName MajorTopicYN="N">metabolism</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N">Gelatin</DescriptorName><QualifierName MajorTopicYN="Y">pharmacokinetics</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N">Indium Radioisotopes</DescriptorName><QualifierName MajorTopicYN="N">diagnostic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N">Methylcellulose</DescriptorName><QualifierName MajorTopicYN="Y">analogs & derivatives</QualifierName><QualifierName MajorTopicYN="N">pharmacokinetics</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N">Single-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N">Stomach</DescriptorName><QualifierName MajorTopicYN="N">metabolism</QualifierName><QualifierName MajorTopicYN="N">radionuclide imaging</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N">Technetium Tc 99m Pentetate</DescriptorName><QualifierName MajorTopicYN="N">diagnostic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N">Young Adult</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2011</Year><Month>10</Month><Day>24</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2011</Year><Month>12</Month><Day>16</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2011</Year><Month>12</Month><Day>21</Day></PubMedPubDate><PubMedPubDate PubStatus="aheadofprint"><Year>2011</Year><Month>12</Month><Day>28</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2012</Year><Month>1</Month><Day>5</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2012</Year><Month>1</Month><Day>5</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2012</Year><Month>7</Month><Day>3</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pii">S0378-5173(11)01160-4</ArticleId><ArticleId IdType="doi">10.1016/j.ijpharm.2011.12.034</ArticleId><ArticleId IdType="pubmed">22214655</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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