Evidence map›Paper›PMID 21674263›Full record

ArticlePharmaceutical research2011

Improved ziprasidone formulations with enhanced bioavailability in the fasted state and a reduced food effect.

Avinash G Thombre, Scott M Herbig, Jeffrey A Alderman

Abstract read
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In one paragraph

Article in Pharmaceutical research, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.9field-weighted citation impact, top 14% of its field
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

7 citing papers in PubMed, 34 citations in OpenAlex.

  1. Review
  2. Article
  3. Physiologically-based pharmacokinetics of ziprasidone in pregnant women.British journal of clinical pharmacology · 2019
    Article
  4. Article
  5. Review
  6. Review
  7. 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

3 authors at 1 institution in 1 country.

Avinash G ThombreWorldwide Research and Development, Pfizer Inc., Eastern Point Road, Groton, Connecticut 06340, USA. avinash.g.thombre@pfizer.com
Scott M Herbig
Jeffrey A Alderman
Pfizer (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo develop and characterize new formulations of ziprasidone with a reduced food effect achieved by increasing exposure in the fasted state.

methodsFormulations were developed utilizing the following solubilization technologies: inclusion complex of ziprasidone mesylate and cyclodextrin, ziprasidone free base nano-suspension, and semi-ordered ziprasidone HCl in polymer matrix. Pharmacokinetic studies were conducted with these formulations to examine the bioavailability of test formulations in fasted and fed state compared to commercial capsules (Geodon®) dosed in the fed state.

resultsAll formulations containing solubilized ziprasidone showed either no food effect or a reduced food effect compared to commercial capsules. Two formulations when taken in the fasted or fed state were comparable to the commercial capsules dosed in the fed state with respect to total exposure. However, peak concentrations were ~30-40% higher.

conclusionsPharmacokinetic studies indicated solubilization technologies can be employed to successfully increase the extent of ziprasidone absorption in the fasted state, thereby reducing the food effect. Such formulations could provide simple and convenient dosing while retaining the familiar safety and efficacy profile of currently marketed capsules.

Indexed as

Area Under CurveBiological AvailabilityDopamine AntagonistsExcipientsFastingFood-Drug InteractionsHumansPiperazinesSolubilityThiazolesDopamine AntagonistsExcipientsPiperazinesThiazolesziprasidone

Identifiers

PMID21674263
OpenAlexW1966929033

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.