Evidence map›Paper›PMID 38774112›Full record

ArticleInternational journal of pharmaceutics: X2024

Evaluation of gender differences in the pharmacokinetics of oral zileuton nanocrystalline formulation using a rat model.

Chandra Mohan Reddy Muthumula, Sangeeta Khare, Rajan Jog, Bhagya Wickramaratne, Angela Lee, Sushanta Chakder, Diane J Burgess, Kuppan Gokulan

Abstract read
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In one paragraph

Article in International journal of pharmaceutics: X, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

8 authors.

Chandra Mohan Reddy MuthumulaDivision of Microbiology, National Center for Toxicological Research, US Food and Drug Administration, 3900 NCTR Rd, Jefferson, AR 72079, United States of America.
Sangeeta KhareDivision of Microbiology, National Center for Toxicological Research, US Food and Drug Administration, 3900 NCTR Rd, Jefferson, AR 72079, United States of America.
Rajan JogDepartment of Pharmaceutical Sciences, University of Connecticut, Storrs, CT 06269, United States of America.
Bhagya WickramaratneDivision of Microbiology, National Center for Toxicological Research, US Food and Drug Administration, 3900 NCTR Rd, Jefferson, AR 72079, United States of America.
Angela LeeDivision of Microbiology, National Center for Toxicological Research, US Food and Drug Administration, 3900 NCTR Rd, Jefferson, AR 72079, United States of America.
Sushanta ChakderCenter for Drug Evaluation and Research, US Food and Drug Administration, White Oak Campus, Silver Spring, MD 20993, United States of America.
Diane J BurgessDepartment of Pharmaceutical Sciences, University of Connecticut, Storrs, CT 06269, United States of America.
Kuppan GokulanDivision of Microbiology, National Center for Toxicological Research, US Food and Drug Administration, 3900 NCTR Rd, Jefferson, AR 72079, United States of America.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Zileuton is a leukotriene inhibitor used to treat asthma. As a BCS class II drug it exhibits challenges with solubility which likely impact its absorption. As patient gender significantly impacts the pharmacokinetics of many drugs, this study aimed to investigate potential gender-based pharmacokinetic differences after oral zileuton administration in rats. Male and female Sprague Dawley rats received single oral gavage doses of pure zileuton as an active pharmaceutical ingredient (30 mg/kg body weight (bw)), physical mixture (PM; at 30 mg/kg bw of the formulation contains zileuton, kollidon VA64 fine, dowfax2A1 and trehalose), and nanocrystalline formulation of zileuton (NfZ; at 30 mg/kg bw of the formulation). Plasma, tissue, and urine concentrations were quantified using high performance liquid chromatography (HPLC). Noncompartmental pharmacokinetic analysis showed higher zileuton levels in the plasma of female versus male rats across all evaluated forms of zileuton (API, PM, and NfZ). Female rats demonstrated higher peak plasma concentrations (C

Indexed as

AsthmaBioavailabilityDrug developmentDrug formulationGender differencesLeukotriene inhibitorsNanocrystalsOral drug deliveryPersonalized medicinePharmacokineticsPreclinical researchRat modelZileuton

Identifiers

PMID38774112
PMCPMC11107231

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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.