An In Vitro Analysis of Disintegration Times of Different Formulations of Olanzapine Orodispersible Tablet: A Preliminary Report
Identifieur interne : 000250 ( Main/Exploration ); précédent : 000249; suivant : 000251An 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
Affiliations:
- Canada, Hongrie, États-Unis
- Hongrie centrale, Indiana, Ontario
- Budapest, Toronto
- Université de Toronto
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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="4"><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><orgName type="university">Université de Toronto</orgName><placeName><settlement type="city">Toronto</settlement><region type="state">Ontario</region></placeName></affiliation></author><author><name sortKey="Treuer, Tamas" sort="Treuer, Tamas" uniqKey="Treuer T" first="Tamas" last="Treuer">Tamas Treuer</name><affiliation wicri:level="3"><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><placeName><settlement type="city">Budapest</settlement><region nuts="2">Hongrie centrale</region></placeName></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 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name="Canada"><region name="Ontario"><name sortKey="Karagianis, Jamie" sort="Karagianis, Jamie" uniqKey="Karagianis J" first="Jamie" last="Karagianis">Jamie Karagianis</name></region></country><country name="Hongrie"><region name="Hongrie centrale"><name sortKey="Treuer, Tamas" sort="Treuer, Tamas" uniqKey="Treuer T" first="Tamas" last="Treuer">Tamas Treuer</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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