Evidence map›Paper›PMID 35455497›Full record

ReviewChildren (Basel, Switzerland)2022

The Current States, Challenges, Ongoing Efforts, and Future Perspectives of Pharmaceutical Excipients in Pediatric Patients in Each Country and Region.

Jumpei Saito, Anjali Agrawal, Vandana Patravale, Anjali Pandya, Samuel Orubu, Min Zhao, Gavin P Andrews, Caroline Petit-Turcotte, Hannah Landry, Alysha Croker and 3 more

Open access · goldAbstract readReview
In one paragraph

Review in Children (Basel, Switzerland), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
9.9field-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

12 citing papers in PubMed, 29 citations in OpenAlex.

  1. Article
  2. Review
  3. Pediatric Pharmacy Association 2025 KIDs List of Key Potentially Inappropriate Drugs in Pediatrics.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2025
    Article
  4. Observational
  5. KollicoatPharmaceutics · 2025
    Article
  6. Molecules (Basel, Switzerland) · 2025
    Article
  7. Review
  8. Impact of concerning excipients on animal safety: insights for veterinary pharmacotherapy and regulatory considerations.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2024
    Review
  9. Review
  10. Review
  11. Article
  12. Review
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

13 authors at 7 institutions in 6 countries.

Jumpei SaitoDepartment of Pharmacy, National Center for Child Health and Development, Okura 2-10-1, Setagaya-ku, Tokyo 157-8535, Japan.ORCID 0000-0003-4799-5562
Anjali AgrawalDrug Product Development, Bristol Myers Squibb, 181 Passaic Avenue, Summit, NJ 07901, USA.
Vandana PatravaleDepartment of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, Mumbai 400019, India.
Anjali PandyaDepartment of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, Mumbai 400019, India.
Samuel OrubuDepartment of Biomedical Engineering, Boston University, 44 Cummington Mall, Boston, MA 02215, USA.
Min ZhaoMedical Biology Centre, School of Pharmacy, China Medical University-Queen's University Belfast Joint College (CQC), Queen's University Belfast, 97 Lisburn Road, Belfast BT9 7BL, UK.ORCID 0000-0002-7422-6710
Gavin P AndrewsMedical Biology Centre, School of Pharmacy, China Medical University-Queen's University Belfast Joint College (CQC), Queen's University Belfast, 97 Lisburn Road, Belfast BT9 7BL, UK.
Caroline Petit-TurcotteTherapeutic Products Directorate, Health Canada, Government of Canada, Ottawa, ON K1A 0K9, Canada.
Hannah LandryOffice of Pediatrics and Patient Involvement, Health Canada, Government of Canada, Ottawa, ON K1A 0K9, Canada.
Alysha CrokerOffice of Pediatrics and Patient Involvement, Health Canada, Government of Canada, Ottawa, ON K1A 0K9, Canada.
Hidefumi NakamuraDepartment of Research and Development Supervision, National Center for Child Health and Development, Tokyo 157-8535, Japan.
Akimasa YamataniDepartment of Pharmacy, National Center for Child Health and Development, Okura 2-10-1, Setagaya-ku, Tokyo 157-8535, Japan.
Smita SalunkeUCL School of Pharmacy, 29-39 Brunswick Square, London WC1N 1AX, UK.
Health Canada · CANational Center For Child Health and Development · JPInstitute of Chemical Technology · INQueen's University Belfast · GBBoston University · USBristol-Myers Squibb (United States) · USUniversity College London · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A major hurdle in pediatric formulation development is the lack of safety and toxicity data on some of the commonly used excipients. While the maximum oral safe dose for several kinds of excipients is known in the adult population, the doses in pediatric patients, including preterm neonates, are not established yet due to the lack of evidence-based data. This paper consists of four parts: (1) country-specific perspectives in different parts of the world (current state, challenges in excipients, and ongoing efforts) for ensuring the use of safe excipients, (2) comparing and contrasting the country-specific perspectives, (3) past and ongoing collaborative efforts, and (4) future perspectives on excipients for pediatric formulation. The regulatory process for pharmaceutical excipients has been developed. However, there are gaps between each region where a lack of information and an insufficient regulation process was found. Ongoing efforts include raising issues on excipient exposure, building a region-specific database, and improving excipient regulation; however, there is a lack of evidence-based information on safety for the pediatric population. More progress on clear safety limits, quantitative information on excipients of concern in the pediatric population, and international harmonization of excipients' regulatory processes for the pediatric population are required.

Indexed as

age-appropriate dosage formexcipientspediatric patients

Identifiers

PMID35455497
PMCPMC9026161
OpenAlexW4224324566

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.