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Article

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

1
Department of Biomedical Sciences, Mercer University School of Medicine, Columbus, GA 31902, USA
2
Department of Pharmacy Services, Children’s Health System of Texas, Dallas, TX 75235, USA
3
Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton, AB T6G 2R3, Canada
4
School of Pharmacy, Philadelphia College of Osteopathic Medicine, Suwanee, GA 30024, USA
5
Department of Pediatrics, Drexel University College of Medicine, Philadelphia, PA 19129, USA
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Department of Pharmacy Services, St. Christopher’s Hospital for Children/Tower Health, Philadelphia, PA 19134, USA
7
Department of Pharmacy Services, Rockefeller University Hospital, New York, NY 10065, USA
*
Author to whom correspondence should be addressed.
Academic Editor: Melgardt de Villiers
Pharmaceutics 2022, 14(5), 1032; https://doi.org/10.3390/pharmaceutics14051032
Received: 3 March 2022 / Revised: 6 May 2022 / Accepted: 7 May 2022 / Published: 10 May 2022
(This article belongs to the Special Issue Feature Papers in Physical Pharmacy and Formulation)
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. View Full-Text
Keywords: active pharmaceutical ingredient; compounded drug; compounding; extemporaneous formulation; manufactured material; medication; monograph; pediatric; reference standards active pharmaceutical ingredient; compounded drug; compounding; extemporaneous formulation; manufactured material; medication; monograph; pediatric; reference standards
  • Externally hosted supplementary file 1
    Doi: 10.20944/preprints202203.0117.v3
MDPI and ACS Style

Parrish, R.H., II; Ashworth, L.D.; Löbenberg, R.; Benavides, S.; Cies, J.J.; MacArthur, R.B. Compounded Nonsterile Preparations and FDA-Approved Commercially Available Liquid Products for Children: A North American Update. Pharmaceutics 2022, 14, 1032. https://doi.org/10.3390/pharmaceutics14051032

AMA Style

Parrish RH II, Ashworth LD, Löbenberg R, Benavides S, Cies JJ, MacArthur RB. Compounded Nonsterile Preparations and FDA-Approved Commercially Available Liquid Products for Children: A North American Update. Pharmaceutics. 2022; 14(5):1032. https://doi.org/10.3390/pharmaceutics14051032

Chicago/Turabian Style

Parrish, Richard H., II, Lisa D. Ashworth, Raimar Löbenberg, Sandra Benavides, Jeffrey J. Cies, and Robert B. MacArthur. 2022. "Compounded Nonsterile Preparations and FDA-Approved Commercially Available Liquid Products for Children: A North American Update" Pharmaceutics 14, no. 5: 1032. https://doi.org/10.3390/pharmaceutics14051032

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