Evidence map›Paper›PMID 37508687›Full record

ArticleChildren (Basel, Switzerland)2023

Study on the Preparation Method of Quality-Assured In-Hospital Drug Formulation for Children-A Multi-Institutional Collaborative Study.

Jumpei Saito, Eiji Suzuki, Yosuke Nakamura, Takashi Otsuji, Hiroshi Yamamoto, Hideki Yamamoto, Yuiko Kai, Maiko Totsu, Sayuki Hashimoto, Hidefumi Nakamura and 2 more

Abstract read
In one paragraph

Article in Children (Basel, Switzerland), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

12 authors.

Jumpei SaitoDepartment of Pharmacy, National Center for Child Health and Development, Tokyo 157-8535, Japan.ORCID 0000-0003-4799-5562
Eiji SuzukiDepartment of Pharmacy, Nagano Children's Hospital, Nagano 399-8288, Japan.
Yosuke NakamuraDepartment of Pharmacy, Shiga Medical Center for Children, Moriyama 524-0022, Japan.
Takashi OtsujiDepartment of Pharmacy, Shiga Medical Center for Children, Moriyama 524-0022, Japan.
Hiroshi YamamotoDepartment of Pharmacy, NHO Shikoku Medical Center for Children and Adults, Zentsuji 765-8507, Japan.
Hideki YamamotoDepartment of Pharmacy, NHO Shikoku Medical Center for Children and Adults, Zentsuji 765-8507, Japan.
Yuiko KaiDepartment of Pharmacy, Kanagawa Children's Medical Center, Yokohama 232-0066, Japan.
Maiko TotsuDepartment of Pharmacy, Kanagawa Children's Medical Center, Yokohama 232-0066, Japan.
Sayuki HashimotoDepartment of Pharmacy, Aichi Developmental Disability Center, Kasugai 480-0392, Japan.
Hidefumi NakamuraDepartment of Research and Development Supervision, National Center for Child Health and Development, Tokyo 157-8535, Japan.
Miki AkabaneDepartment of Pharmacy, National Center for Child Health and Development, Tokyo 157-8535, Japan.
Akimasa YamataniDepartment of Pharmacy, National Center for Child Health and Development, Tokyo 157-8535, Japan.ORCID 0000-0003-2960-5161

Funding

Japanese Agency for Medical Research and Development 23mk0101243h0002
6 · The paper itself

Abstract

The quality-assured preparation of crushed and diluted preparations for children is a challenge. In this study, a multicenter study was conducted to validate the preparation method for the quality assurance of baclofen powder, clonidine powder, and hydrocortisone powder prepared from tablets according to a previously established method. In-hospital preparations were prepared at five medical facilities under different crushing and mixing conditions. After storage in closed bottles, in-use bottles, and laminated paper for 120 days, ingredients stability, drug elution, and content uniformity after packaging were evaluated. All three ingredients were maintained at between 90% and 110% of their initial content for 120 days under packaging conditions of 25 ± 2 °C and 60 ± 5% relative humidity, with no change in dissolution in all formulations made at all five facilities. The content uniformity was also acceptable. The established method may contribute to quality-assured pediatric dosage form modification.

Indexed as

oral powderpediatric formulationquality assurancestability

Identifiers

PMID37508687
PMCPMC10378225

What OpenQuestion holds

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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.