An In Vitro Analysis of Disintegration Times of Different Formulations of Olanzapine Orodispersible Tablet: A Preliminary Report
Identifieur interne : 000082 ( Pmc/Curation ); précédent : 000081; suivant : 000083An In Vitro Analysis of Disintegration Times of Different Formulations of Olanzapine Orodispersible Tablet: A Preliminary Report
Auteurs : David Hobbs [États-Unis] ; Jamie Karagianis [Canada] ; Tamas Treuer [Hongrie] ; Joel RaskinSource :
- Drugs in R&D [ 1174-5886 ] ; 2013.
Abstract
Orodispersible tablets (ODTs) are tablet or wafer forms of medication that disintegrate in the mouth, aided only by saliva. ODTs rely on different fast dissolve/disintegration manufacturing technologies.
Disintegration time differences for several olanzapine ODT forms were investigated. Risperdal M-Tab® was included as a non-olanzapine ODT comparator.
Eleven olanzapine ODT examples and orodispersible risperidone strengths were evaluated in vitro for formulation composition, manufacturing method, disintegration and dissolution characteristics, and formulation differences in comparison with freeze dried Zydis® ODT. Automated dissolution test equipment captured ODT dissolution rates by measuring real-time release of active ingredient. A high-speed video camera was used to capture tablet disintegration times in warm simulated saliva.
The main outcome measure was the disintegration and dissolution characteristics of the ODT formulations.
The ODT manufacturing method was associated with time to disintegrate; the fastest were freeze dried tablets, followed by soft compressed tablets and then hard/dense tablets. Olanzapine Zydis® was the only ODT that completely disintegrated in less than 4 s for all strengths (5, 10, 15, and 20 mg), followed by 5-mg Prolanz FAST® (12 s) and then risperidone ODT 4 mg (40 s). Reasons for slow dissolution of the olanzapine generics may include low product potency, excipient binding, excipient solubility, active ingredient particle size and incomplete disintegration.
Differences in the formulation and manufacturing process of olanzapine ODTs appear to have a strong influence on the disintegration time of the active compound; differences that may potentially impact their use in clinical practice.
The online version of this article (doi:10.1007/s40268-013-0030-8) contains supplementary material, which is available to authorized users.
Url:
DOI: 10.1007/s40268-013-0030-8
PubMed: 24170256
PubMed Central: 3879822
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Jamie Karagianis<affiliation><nlm:aff id="Aff2">Waypoint Centre for Mental Health, 500 Church St, Penetanguishene, ON L9M 1G3 Canada</nlm:aff><wicri:noCountry code="subfield">ON L9M 1G3 Canada</wicri:noCountry></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff3">Department of Psychiatry, University of Toronto, Toronto, Canada</nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Psychiatry, University of Toronto, Toronto</wicri:regionArea></affiliation><affiliation><nlm:aff id="Aff5">Eli Lilly Canada Inc., 3650 Danforth Avenue, Toronto, ON M1N 2E8 Canada</nlm:aff><wicri:noCountry code="subfield">ON M1N 2E8 Canada</wicri:noCountry></affiliation>Le document en format XML
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Hobbs</name><affiliation wicri:level="2"><nlm:aff id="Aff1">Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285 USA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Indiana</region></placeName><wicri:cityArea>Eli Lilly and Company, Lilly Corporate Center, Indianapolis</wicri:cityArea></affiliation></author><author><name sortKey="Karagianis, Jamie" sort="Karagianis, Jamie" uniqKey="Karagianis J" first="Jamie" last="Karagianis">Jamie Karagianis</name><affiliation><nlm:aff id="Aff2">Waypoint Centre for Mental Health, 500 Church St, Penetanguishene, ON L9M 1G3 Canada</nlm:aff><wicri:noCountry code="subfield">ON L9M 1G3 Canada</wicri:noCountry></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff3">Department of Psychiatry, University of Toronto, Toronto, Canada</nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Psychiatry, University of Toronto, Toronto</wicri:regionArea></affiliation></author><author><name sortKey="Treuer, Tamas" sort="Treuer, Tamas" uniqKey="Treuer T" first="Tamas" last="Treuer">Tamas Treuer</name><affiliation wicri:level="1"><nlm:aff id="Aff4">Eli Lilly and Company, Madach I. u. 13-14, Budapest, 1075 Hungary</nlm:aff><country xml:lang="fr">Hongrie</country><wicri:regionArea>Eli Lilly and Company, Madach I. u. 13-14, Budapest</wicri:regionArea></affiliation></author><author><name sortKey="Raskin, Joel" sort="Raskin, Joel" uniqKey="Raskin J" first="Joel" last="Raskin">Joel Raskin</name><affiliation><nlm:aff id="Aff5">Eli Lilly Canada Inc., 3650 Danforth Avenue, Toronto, ON M1N 2E8 Canada</nlm:aff><wicri:noCountry code="subfield">ON M1N 2E8 Canada</wicri:noCountry></affiliation></author></analytic><series><title level="j">Drugs in R&D</title><idno type="ISSN">1174-5886</idno><idno type="eISSN">1179-6901</idno><imprint><date when="2013">2013</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>Orodispersible tablets (ODTs) are tablet or wafer forms of medication that disintegrate in the mouth, aided only by saliva. ODTs rely on different fast dissolve/disintegration manufacturing technologies.</p></sec><sec><title>Objectives</title><p>Disintegration time differences for several olanzapine ODT forms were investigated. Risperdal M-Tab<sup>®</sup> was included as a non-olanzapine ODT comparator.</p></sec><sec><title>Research Design and Methods</title><p>Eleven olanzapine ODT examples and orodispersible risperidone strengths were evaluated in vitro for formulation composition, manufacturing method, disintegration and dissolution characteristics, and formulation differences in comparison with freeze dried Zydis<sup>®</sup> ODT. Automated dissolution test equipment captured ODT dissolution rates by measuring real-time release of active ingredient. A high-speed video camera was used to capture tablet disintegration times in warm simulated saliva.</p></sec><sec><title>Main Outcome Measure</title><p>The main outcome measure was the disintegration and dissolution characteristics of the ODT formulations.</p></sec><sec><title>Results</title><p>The ODT manufacturing method was associated with time to disintegrate; the fastest were freeze dried tablets, followed by soft compressed tablets and then hard/dense tablets. Olanzapine Zydis<sup>®</sup> was the only ODT that completely disintegrated in less than 4 s for all strengths (5, 10, 15, and 20 mg), followed by 5-mg Prolanz FAST<sup>®</sup> (12 s) and then risperidone ODT 4 mg (40 s). Reasons for slow dissolution of the olanzapine generics may include low product potency, excipient binding, excipient solubility, active ingredient particle size and incomplete disintegration.</p></sec><sec><title>Conclusions</title><p>Differences in the formulation and manufacturing process of olanzapine ODTs appear to have a strong influence on the disintegration time of the active compound; differences that may potentially impact their use in clinical practice.</p></sec><sec><title>Electronic supplementary material</title><p>The online version of this article (doi:10.1007/s40268-013-0030-8) contains supplementary material, which is available to authorized users.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Mohamed, S" uniqKey="Mohamed S">S Mohamed</name></author><author><name sortKey="Rosenheck, R" uniqKey="Rosenheck R">R Rosenheck</name></author><author><name sortKey="Mcevoy, J" uniqKey="Mcevoy J">J McEvoy</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Bitter, I" uniqKey="Bitter I">I Bitter</name></author><author><name sortKey="Treuer, T" uniqKey="Treuer T">T Treuer</name></author><author><name sortKey="Dilbaz, N" uniqKey="Dilbaz N">N Dilbaz</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Kahn, Rs" uniqKey="Kahn R">RS Kahn</name></author><author><name sortKey="Fleischhacker, Ww" uniqKey="Fleischhacker W">WW Fleischhacker</name></author><author><name sortKey="Boter, H" uniqKey="Boter H">H Boter</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Lieberman, Ja" uniqKey="Lieberman J">JA Lieberman</name></author><author><name sortKey="Stroup, Ts" uniqKey="Stroup T">TS Stroup</name></author><author><name sortKey="Mcevoy, Jp" uniqKey="Mcevoy J">JP McEvoy</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Novick, D" uniqKey="Novick D">D Novick</name></author><author><name sortKey="Haro, Jm" uniqKey="Haro J">JM Haro</name></author><author><name sortKey="Suarez, D" uniqKey="Suarez D">D Suarez</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Bitter, I" uniqKey="Bitter I">I Bitter</name></author><author><name sortKey="Treuer, T" uniqKey="Treuer T">T Treuer</name></author><author><name sortKey="Dyachkova, Y" uniqKey="Dyachkova Y">Y Dyachkova</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Dossenbach, M" uniqKey="Dossenbach M">M Dossenbach</name></author><author><name sortKey="Pecenak, J" uniqKey="Pecenak J">J Pecenak</name></author><author><name sortKey="Szulc, A" uniqKey="Szulc A">A Szulc</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Leucht, S" uniqKey="Leucht S">S Leucht</name></author><author><name sortKey="Komossa, K" uniqKey="Komossa K">K Komossa</name></author><author><name sortKey="Rummel Kluge, C" uniqKey="Rummel Kluge C">C Rummel-Kluge</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Leucht, S" uniqKey="Leucht S">S Leucht</name></author><author><name sortKey="Corves, C" uniqKey="Corves C">C Corves</name></author><author><name sortKey="Arbter, D" uniqKey="Arbter D">D Arbter</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Ghosh, T" uniqKey="Ghosh T">T Ghosh</name></author><author><name sortKey="Ghosh, A" uniqKey="Ghosh A">A Ghosh</name></author><author><name sortKey="Prasad, D" uniqKey="Prasad D">D Prasad</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Bergstrom, Rf" uniqKey="Bergstrom R">RF Bergstrom</name></author><author><name sortKey="Mitchell, M" uniqKey="Mitchell M">M Mitchell</name></author><author><name sortKey="Witcher, J" uniqKey="Witcher J">J Witcher</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="San, L" uniqKey="San L">L San</name></author><author><name sortKey="Casillas, M" uniqKey="Casillas M">M Casillas</name></author><author><name sortKey="Ciudad, A" uniqKey="Ciudad A">A Ciudad</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Karagianis, J" uniqKey="Karagianis J">J Karagianis</name></author><author><name sortKey="Grossman, L" uniqKey="Grossman L">L Grossman</name></author><author><name sortKey="Landry, J" uniqKey="Landry J">J Landry</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Chue, P" uniqKey="Chue P">P Chue</name></author><author><name sortKey="Jones, B" uniqKey="Jones B">B Jones</name></author><author><name sortKey="Taylor, Cc" uniqKey="Taylor C">CC Taylor</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Chue, P" uniqKey="Chue P">P Chue</name></author><author><name sortKey="Welch, R" uniqKey="Welch R">R Welch</name></author><author><name sortKey="Binder, C" uniqKey="Binder C">C Binder</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Giannola, Li" uniqKey="Giannola L">LI Giannola</name></author><author><name sortKey="De Caro, V" uniqKey="De Caro V">V De Caro</name></author><author><name sortKey="Giandalia, G" uniqKey="Giandalia G">G Giandalia</name></author><author><name sortKey="Siragusa, Mg" uniqKey="Siragusa M">MG Siragusa</name></author><author><name sortKey="Tripodo, C" uniqKey="Tripodo C">C Tripodo</name></author><author><name sortKey="Florena, Am" uniqKey="Florena A">AM Florena</name></author><author><name sortKey="Campisi, G" uniqKey="Campisi G">G Campisi</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Gal, Jy" uniqKey="Gal J">JY Gal</name></author><author><name sortKey="Fovet, Y" uniqKey="Fovet Y">Y Fovet</name></author><author><name sortKey="Adib Yadzi" uniqKey="Adib Yadzi">Adib-Yadzi</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Chue, P" uniqKey="Chue P">P Chue</name></author><author><name sortKey="Prinzo, Rs" uniqKey="Prinzo R">RS Prinzo</name></author><author><name sortKey="Binder, Ce" uniqKey="Binder C">CE Binder</name></author></analytic></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><pmc article-type="brief-report"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Drugs R D</journal-id><journal-id journal-id-type="iso-abbrev">Drugs R D</journal-id><journal-title-group><journal-title>Drugs in R&D</journal-title></journal-title-group><issn pub-type="ppub">1174-5886</issn><issn pub-type="epub">1179-6901</issn><publisher><publisher-name>Springer International Publishing</publisher-name><publisher-loc>Cham</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">24170256</article-id><article-id pub-id-type="pmc">3879822</article-id><article-id pub-id-type="publisher-id">30</article-id><article-id pub-id-type="doi">10.1007/s40268-013-0030-8</article-id><article-categories><subj-group subj-group-type="heading"><subject>Short Communication</subject></subj-group></article-categories><title-group><article-title>An In Vitro Analysis of Disintegration Times of Different Formulations of Olanzapine Orodispersible Tablet: A Preliminary Report</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Hobbs</surname><given-names>David</given-names></name><address><phone>+1-317-2775522</phone><fax>+1-317-2765375</fax><email>hobbsdg@lilly.com</email></address><xref ref-type="aff" rid="Aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Karagianis</surname><given-names>Jamie</given-names></name><xref ref-type="aff" rid="Aff2"></xref><xref ref-type="aff" rid="Aff3"></xref></contrib><contrib contrib-type="author"><name><surname>Treuer</surname><given-names>Tamas</given-names></name><xref ref-type="aff" rid="Aff4"></xref></contrib><contrib contrib-type="author"><name><surname>Raskin</surname><given-names>Joel</given-names></name><xref ref-type="aff" rid="Aff5"></xref></contrib><aff id="Aff1"><label></label>Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285 USA</aff><aff id="Aff2"><label></label>Waypoint Centre for Mental Health, 500 Church St, Penetanguishene, ON L9M 1G3 Canada</aff><aff id="Aff3"><label></label>Department of Psychiatry, University of Toronto, Toronto, Canada</aff><aff id="Aff4"><label></label>Eli Lilly and Company, Madach I. u. 13-14, Budapest, 1075 Hungary</aff><aff id="Aff5"><label></label>Eli Lilly Canada Inc., 3650 Danforth Avenue, Toronto, ON M1N 2E8 Canada</aff></contrib-group><pub-date pub-type="epub"><day>30</day><month>10</month><year>2013</year></pub-date><pub-date pub-type="pmc-release"><day>30</day><month>10</month><year>2013</year></pub-date><pub-date pub-type="ppub"><month>12</month><year>2013</year></pub-date><volume>13</volume><issue>4</issue><fpage>281</fpage><lpage>288</lpage><permissions><copyright-statement>© The Author(s) 2013</copyright-statement><license license-type="OpenAccess"><license-p><bold>Open Access</bold>This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.</license-p></license></permissions><abstract id="Abs1"><sec><title>Background</title><p>Orodispersible tablets (ODTs) are tablet or wafer forms of medication that disintegrate in the mouth, aided only by saliva. ODTs rely on different fast dissolve/disintegration manufacturing technologies.</p></sec><sec><title>Objectives</title><p>Disintegration time differences for several olanzapine ODT forms were investigated. Risperdal M-Tab<sup>®</sup> was included as a non-olanzapine ODT comparator.</p></sec><sec><title>Research Design and Methods</title><p>Eleven olanzapine ODT examples and orodispersible risperidone strengths were evaluated in vitro for formulation composition, manufacturing method, disintegration and dissolution characteristics, and formulation differences in comparison with freeze dried Zydis<sup>®</sup> ODT. Automated dissolution test equipment captured ODT dissolution rates by measuring real-time release of active ingredient. A high-speed video camera was used to capture tablet disintegration times in warm simulated saliva.</p></sec><sec><title>Main Outcome Measure</title><p>The main outcome measure was the disintegration and dissolution characteristics of the ODT formulations.</p></sec><sec><title>Results</title><p>The ODT manufacturing method was associated with time to disintegrate; the fastest were freeze dried tablets, followed by soft compressed tablets and then hard/dense tablets. Olanzapine Zydis<sup>®</sup> was the only ODT that completely disintegrated in less than 4 s for all strengths (5, 10, 15, and 20 mg), followed by 5-mg Prolanz FAST<sup>®</sup> (12 s) and then risperidone ODT 4 mg (40 s). Reasons for slow dissolution of the olanzapine generics may include low product potency, excipient binding, excipient solubility, active ingredient particle size and incomplete disintegration.</p></sec><sec><title>Conclusions</title><p>Differences in the formulation and manufacturing process of olanzapine ODTs appear to have a strong influence on the disintegration time of the active compound; differences that may potentially impact their use in clinical practice.</p></sec><sec><title>Electronic supplementary material</title><p>The online version of this article (doi:10.1007/s40268-013-0030-8) contains supplementary material, which is available to authorized users.</p></sec></abstract><custom-meta-group><custom-meta><meta-name>issue-copyright-statement</meta-name><meta-value>© Springer International Publishing Switzerland 2013</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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