Evidence map›Paper›PMID 37765162›Full record

ArticlePharmaceutics2023

Development of an In Vitro Methodology to Assess the Bioequivalence of Orally Disintegrating Tablets Taken without Water.

Toshihide Takagi, Takato Masada, Keiko Minami, Makoto Kataoka, Shinji Yamashita

Open access · goldAbstract read
In one paragraph

Article in Pharmaceutics, 2023. 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
0.7field-weighted citation impact, top 35% 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

2 citing papers in PubMed, 6 citations in OpenAlex.

  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

5 authors at 2 institutions in 1 country.

Toshihide TakagiFaculty of Pharmaceutical Sciences, Setsunan University, Osaka 573-0101, Japan.ORCID 0000-0003-1199-4015
Takato MasadaFaculty of Pharmaceutical Sciences, Setsunan University, Osaka 573-0101, Japan.
Keiko MinamiFaculty of Pharmaceutical Sciences, Setsunan University, Osaka 573-0101, Japan.
Makoto KataokaFaculty of Pharmaceutical Sciences, Setsunan University, Osaka 573-0101, Japan.
Shinji YamashitaResearch Organization of Science and Technology, Ritsumeikan University, Kusatsu 525-8577, Japan.
Setsunan University · JPRitsumeikan University · JP

Funding

Japan Agency for Medical Research and Development JP17ak0101074
6 · The paper itself

Abstract

To assess the probability of bioequivalence (BE) between orally disintegrating tablets (ODTs) taken without water and conventional tablets (CTs) taken with water, an in vitro biorelevant methodology was developed using the BE Checker, which reproduces fluid shifts in the gastrointestinal tract and drug permeation. In addition to the fluid shift from the stomach to the small intestine, the process of ODT disintegration in a small amount of fluid in the oral cavity and the difference in gastric emptying caused by differences in water intake were incorporated into the evaluation protocol. Assuming a longer time to maximum plasma concentration after oral administration of ODTs taken without water than for CTs taken with water due to a delay in gastric emptying, the fluid shift in the donor chamber of the BE Checker without water was set longer than that taken with water. In the case of naftopidil ODTs and CTs, the values of the f

Indexed as

bioequivalencebiorelevant dissolutiondrug permeationgastric emptyinggastrointestinal physiologyorally disintegrating tablets

Identifiers

PMID37765162
PMCPMC10535823
OpenAlexW4386141711

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.