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Compounded Nonsterile Preparations and FDA-Approved Commercially Available Liquid Products for Children: A North American Update
Journal article   Open access   Peer reviewed

Compounded Nonsterile Preparations and FDA-Approved Commercially Available Liquid Products for Children: A North American Update

Richard H Parrish, 2nd, Lisa D Ashworth, Raimar Löbenberg, Sandra Benavides, Jeffrey J Cies and Robert B MacArthur
Pharmaceutics, v 14(5), p1032
10 May 2022
PMID: 35631618
url
https://www.mdpi.com/1999-4923/14/5/1032/pdf?version=1652317587View
Published, Version of Record (VoR) Open
url
https://doi.org/10.3390/pharmaceutics14051032View
Published, Version of Record (VoR) Open

Abstract

compounding monograph active pharmaceutical ingredient extemporaneous formulation medication compounded drug reference standards manufactured material pediatric
The purpose of this work was to evaluate the suitability of recent US Food and Drug Administration (US-FDA)-approved and marketed oral liquid, powder, or granule products for children in North America, to identify the next group of Active Pharmaceutical Ingredients (APIs) that have high potential for development as commercially available FDA-approved finished liquid dosage forms, and to propose lists of compounded nonsterile preparations (CNSPs) that should be developed as commercially available FDA-approved finished liquid dosage forms, as well as those that pharmacists should continue to compound extemporaneously. Through this identification and categorization process, the pharmaceutical industry, government, and professionals are encouraged to continue to work together to improve the likelihood that patients will receive high-quality standardized extemporaneously compounded CNSPs and US-FDA-approved products.

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7 citations in Scopus

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Web of Science research areas
Pharmacology & Pharmacy
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