Evidence map›Paper›PMID 24170256›Full record

ArticleDrugs in R&D2013

An in vitro analysis of disintegration times of different formulations of olanzapine orodispersible tablet: a preliminary report.

David Hobbs, Jamie Karagianis, Tamas Treuer, Joel Raskin

Abstract readComparative Study
In one paragraph

Article in Drugs in R&D, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

David HobbsEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA, hobbsdg@lilly.com.
Jamie Karagianis
Tamas Treuer
Joel Raskin

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOrodispersible 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.

objectivesDisintegration time differences for several olanzapine ODT forms were investigated. Risperdal M-Tab(®) was included as a non-olanzapine ODT comparator. RESEARCH DESIGN AND

methodsEleven 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.

main outcome measureThe main outcome measure was the disintegration and dissolution characteristics of the ODT formulations.

resultsThe 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.

conclusionsDifferences 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.

Indexed as

Antipsychotic AgentsBenzodiazepinesChemistry, PharmaceuticalDose-Response Relationship, DrugDrugs, GenericExcipientsHumansIn Vitro TechniquesOlanzapineParticle SizeRisperidoneSaliva, ArtificialSolubilityTabletsTime FactorsVideo RecordingAntipsychotic AgentsBenzodiazepinesDrugs, GenericExcipientsOlanzapineRisperidoneSaliva, ArtificialTablets

Identifiers

PMID24170256
PMCPMC3879822

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.