2.50
Hdl Handle:
http://hdl.handle.net/10755/163061
Type:
Presentation
Title:
Rapid Onset of Absorption with Olanzapine Orally-Disintegrating Tablets
Abstract:
Rapid Onset of Absorption with Olanzapine Orally-Disintegrating Tablets
Conference Sponsor:Emergency Nurses Association
Conference Year:2004
Author:S Yadav Marya, Rashmi
P.I. Institution Name:Eli Lilly and Company
Title:Neuroscience Medical Liaison
Contact Address:59 Lakefront, Irvine, CA, 92604, USA
Contact Telephone:(949) 262-0212
Purpose: Orally-disintegrating tablets (ODT) of olanzapine may be useful as an alternative formulation for
acutely agitated patients, and are favored by clinicians because of a clinical impression of rapid action. In a
post-hoc analysis, we evaluated olanzapine concentration profiles following ODT and standard oral tablets
(SOT) to assess differences in absorption.
Design: Healthy subjects participated in three randomized, open-label crossover bioequivalence studies
and received olanzapine SOT and ODT.
Setting: Subjects remained at the study site from the evening prior to dosing until 36 hours later. Subjects
fasted overnight until 4 hours after dosing. SOT was given with 100 mL water. ODT was given without
water.
Sample: Subjects were mostly white men with a mean age of 30 years.
Methodology: Subjects were randomized to receive single-dose olanzapine ODT either 5mg (n = 19),
10mg (n = 20), or 20mg (n = 20) once and a corresponding dose of SOT on a separate occasion (with plus or minus
13 days between dosing). Peak plasma concentration (Cmax), time of peak plasma concentration (Tmax), and
plasma concentration over time (AUC) was measured. A post-hoc analysis was conducted to assess the
early onset of absorption.
Results: ODT and SOT treatments exhibited similar plasma concentration profiles (Cmax, Tmax, AUC) and
were statistically evaluated as being bioequivalent. In the 5 mg trial, 79% of ODT vs. 0% of SOT patients
had measurable olanzapine concentrations at 15 minutes. Significantly more subjects receiving ODT had
higher olanzapine concentrations over the first hour vs. SOT (e.g. 63% vs. 10% plus or minus 1 ng/ml at 45 minutes).
Similar differences in the early concentration profiles were also observed for the 10 mg and 20 mg ODT
doses. The small early concentration differences became indistinguishable before maximum plasma concentrations
were attained.
Conclusions: Olanzapine ODT and SOT were bioequivalent; nonetheless, there was a faster onset of GI
absorption for ODT than for SOT, possibly due to rapid disintegration. Although clinical studies are needed,
these results support the general clinical observation that olanzapine ODT has a more rapid onset of
action than olanzapine SOT, suggesting that olanzapine ODT may be advantageous for treating acutely agitated
patients with psychiatric disorders. [Poster Presentation]
Repository Posting Date:
27-Oct-2011
Date of Publication:
17-Oct-2011
Sponsors:
Emergency Nurses Association

Full metadata record

DC FieldValue Language
dc.typePresentationen_GB
dc.titleRapid Onset of Absorption with Olanzapine Orally-Disintegrating Tabletsen_GB
dc.identifier.urihttp://hdl.handle.net/10755/163061-
dc.description.abstract<table><tr><td colspan="2" class="item-title">Rapid Onset of Absorption with Olanzapine Orally-Disintegrating Tablets</td></tr><tr class="item-sponsor"><td class="label">Conference Sponsor:</td><td class="value">Emergency Nurses Association</td></tr><tr class="item-year"><td class="label">Conference Year:</td><td class="value">2004</td></tr><tr class="item-author"><td class="label">Author:</td><td class="value">S Yadav Marya, Rashmi</td></tr><tr class="item-institute"><td class="label">P.I. Institution Name:</td><td class="value">Eli Lilly and Company</td></tr><tr class="item-author-title"><td class="label">Title:</td><td class="value">Neuroscience Medical Liaison<br/></td></tr><tr class="item-address"><td class="label">Contact Address:</td><td class="value">59 Lakefront, Irvine, CA, 92604, USA</td></tr><tr class="item-phone"><td class="label">Contact Telephone:</td><td class="value">(949) 262-0212</td></tr><tr><td colspan="2" class="item-abstract">Purpose: Orally-disintegrating tablets (ODT) of olanzapine may be useful as an alternative formulation for<br/>acutely agitated patients, and are favored by clinicians because of a clinical impression of rapid action. In a<br/>post-hoc analysis, we evaluated olanzapine concentration profiles following ODT and standard oral tablets<br/>(SOT) to assess differences in absorption.<br/>Design: Healthy subjects participated in three randomized, open-label crossover bioequivalence studies<br/>and received olanzapine SOT and ODT.<br/>Setting: Subjects remained at the study site from the evening prior to dosing until 36 hours later. Subjects<br/>fasted overnight until 4 hours after dosing. SOT was given with 100 mL water. ODT was given without<br/>water.<br/>Sample: Subjects were mostly white men with a mean age of 30 years.<br/>Methodology: Subjects were randomized to receive single-dose olanzapine ODT either 5mg (n = 19),<br/>10mg (n = 20), or 20mg (n = 20) once and a corresponding dose of SOT on a separate occasion (with plus or minus<br/>13 days between dosing). Peak plasma concentration (Cmax), time of peak plasma concentration (Tmax), and<br/>plasma concentration over time (AUC) was measured. A post-hoc analysis was conducted to assess the<br/>early onset of absorption.<br/>Results: ODT and SOT treatments exhibited similar plasma concentration profiles (Cmax, Tmax, AUC) and<br/>were statistically evaluated as being bioequivalent. In the 5 mg trial, 79% of ODT vs. 0% of SOT patients<br/>had measurable olanzapine concentrations at 15 minutes. Significantly more subjects receiving ODT had<br/>higher olanzapine concentrations over the first hour vs. SOT (e.g. 63% vs. 10% plus or minus 1 ng/ml at 45 minutes).<br/>Similar differences in the early concentration profiles were also observed for the 10 mg and 20 mg ODT<br/>doses. The small early concentration differences became indistinguishable before maximum plasma concentrations<br/>were attained.<br/>Conclusions: Olanzapine ODT and SOT were bioequivalent; nonetheless, there was a faster onset of GI<br/>absorption for ODT than for SOT, possibly due to rapid disintegration. Although clinical studies are needed,<br/>these results support the general clinical observation that olanzapine ODT has a more rapid onset of<br/>action than olanzapine SOT, suggesting that olanzapine ODT may be advantageous for treating acutely agitated<br/>patients with psychiatric disorders. [Poster Presentation]</td></tr></table>en_GB
dc.date.available2011-10-27T10:38:53Z-
dc.date.issued2011-10-17en_GB
dc.date.accessioned2011-10-27T10:38:53Z-
dc.description.sponsorshipEmergency Nurses Associationen_GB
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