Preprint Article Version 2 Preserved in Portico This version is not peer-reviewed

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

Version 1 : Received: 3 March 2022 / Approved: 8 March 2022 / Online: 8 March 2022 (08:24:35 CET)
Version 2 : Received: 9 March 2022 / Approved: 10 March 2022 / Online: 10 March 2022 (08:26:21 CET)
Version 3 : Received: 4 April 2022 / Approved: 5 April 2022 / Online: 5 April 2022 (10:17:10 CEST)

A peer-reviewed article of this Preprint also exists.

Parrish II, R.H.; 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 Parrish II, R.H.; 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

Abstract

The purpose of this work was to evaluate the suitability of recently 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 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 the professions are encouraged to continue to work together to improve the likelihood that patients will receive high quality standardized extemporaneous CNSPs and US-FDA-approved products.

Keywords

active pharmaceutical ingredient; compounded drug; compounding; extemporaneous formulation; manufactured material; medication; monograph; pediatric; reference standards

Subject

Medicine and Pharmacology, Pharmacology and Toxicology

Comments (1)

Comment 1
Received: 10 March 2022
Commenter: Richard Parrish
Commenter's Conflict of Interests: Author
Comment: Changes primarily to the first several paragraphs and use of consistent terminology throughout the manuscript.
+ Respond to this comment
Comment 2
Received: 31 March 2022
Commenter: Lucas Orth
The commenter has declared there is no conflict of interests.
Comment: Great work with this update! One note: Three locations (Page 4, Paragraph 1; Table 1 title; and Table 2 title) reference "liquid" dosage forms, but Kapspargo 24h Sprinkle Capsule is one of the included products in the tables. While the sprinkle capsule is potentially helpful for some patients, metoprolol succinate is not to my knowledge available as a commercial liquid. Was this included in the liquid tables by mistake? (Table 2 does note that the fixed doses offered in this product are potentially not suitable).
+ Respond to this comment

We encourage comments and feedback from a broad range of readers. See criteria for comments and our Diversity statement.

Leave a public comment
Send a private comment to the author(s)
* All users must log in before leaving a comment
Views 0
Downloads 0
Comments 1
Metrics 0


×
Alerts
Notify me about updates to this article or when a peer-reviewed version is published.
We use cookies on our website to ensure you get the best experience.
Read more about our cookies here.