Evidence map›Paper›PMID 31683740›Full record

ArticlePharmaceutics2019

Classification of WHO Essential Oral Medicines for Children Applying a Provisional Pediatric Biopharmaceutics Classification System.

Jose-Manuel delMoral-Sanchez, Isabel Gonzalez-Alvarez, Marta Gonzalez-Alvarez, Andres Navarro, Marival Bermejo

Open access · goldAbstract read
In one paragraph

Article in Pharmaceutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
9.8field-weighted citation impact, top 2% 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

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Article
  6. Article
  7. Review
  8. Article
  9. Review
  10. Review
  11. Paediatric Formulation: Design and Development.International journal of molecular sciences · 2020
    Article
  12. Article
  13. Article
  14. Review
  15. 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.

Jose-Manuel delMoral-SanchezDepartment of Pharmacokinetics and Pharmaceutical Technology, Miguel Hernandez University, 03550 San Juan de Alicante, Spain. jmoral@goumh.umh.es.
Isabel Gonzalez-AlvarezDepartment of Pharmacokinetics and Pharmaceutical Technology, Miguel Hernandez University, 03550 San Juan de Alicante, Spain. isabel.gonzalez@goumh.umh.es.ORCID 0000-0002-1685-142X
Marta Gonzalez-AlvarezDepartment of Pharmacokinetics and Pharmaceutical Technology, Miguel Hernandez University, 03550 San Juan de Alicante, Spain. marta.gonzalez@goumh.umh.es.
Andres NavarroPharmacy Service, General University Hospital of Elche, 03203 Elche, Spain. navarro_and@gva.es.
Marival BermejoDepartment of Pharmacokinetics and Pharmaceutical Technology, Miguel Hernandez University, 03550 San Juan de Alicante, Spain. mbermejo@goumh.umh.es.ORCID 0000-0001-5022-0544
Universitat de Miguel Hernández d'Elx · ESHospital General Universitario de Elche · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The objective was using the Essential Medicines List for children by the World Health Organization (WHO) to create a pediatric biopharmaceutics classification system (pBCS) of the oral drugs included in the Essential Medicines List by the World Health Organization and to compare our results with the BCS for adults (aBCS). Several methods to estimate the oral drug dose in different pediatric groups were used to calculate dose number (Do) and solubility (high/low). The estimation of the gastrointestinal water volume was adapted to each pediatric group. Provisional permeability classification was done by comparison of each drug lipophilicity versus metoprolol as the model drug of high permeability. As a result, 24.5% of the included drugs moved from the favorable to unfavorable class (i.e., from high to low solubility). Observed changes point out potential differences in product performance in pediatrics compared to adults, due to changes in the limiting factors for absorption. BCS Class Changes 1 to 2 or 3 to 4 are indicative of drugs that could be more sensitive to the choice of appropriate excipient in the development process. Validating a pBCS for each age group would provide a valuable tool to apply in specific pediatric formulation design by reducing time and costs and avoiding unnecessary pediatric experiments restricted due to ethical reasons. Additionally, pBCS could minimize the associated risks to the use of adult medicines or pharmaceutical compound formulations.

Indexed as

BCSbiopharmaceuticspediatricspermeabilitysecuritysolubility

Identifiers

PMID31683740
PMCPMC6920833
OpenAlexW2982555970

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.