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Pharmacy 2015, 3(4), 284-294; doi:10.3390/pharmacy3040284

An Algorithm to Identify Compounded Non-Sterile Products that Can Be Formulated on a Commercial Scale or Imported to Promote Safer Medication Use in Children

1
Department of Clinical, Social and Administrative Sciences, College of Pharmacy and Department of Pediatrics, Medical School, University of Michigan, Ann Arbor, MI, 48109, USA
2
Med4Kids Research Collaborative, Ltd., Edmonton, AB, T6M 2J9, Canada
3
Clinical Development, Pharmaceutics International, Inc., Hunt Valley, MD, 21031, USA
4
Pharmaceutical Sciences Division, Faculty of Pharmacy and Pharmaceutical Sciences, Edmonton, AB, T6G 2R3, Canada
5
Drug Discovery and Innovation Centre, University of Alberta, Edmonton, AB, T6G 2R3, Canada
6
Drexel University College of Medicine, Philadelphia, PA, 19129, USA
7
St. Christopher’s Hospital for Children, Philadelphia, PA, 19140, USA 8 Military and Veterans’ Clinical Rehabilitation Research, University of Alberta, Edmonton, AB, T6G 2G4, Canada
*
Author to whom correspondence should be addressed.
Academic Editor: Sandra Benavides Caballero
Received: 16 April 2015 / Revised: 31 August 2015 / Accepted: 5 November 2015 / Published: 11 November 2015
(This article belongs to the Special Issue Pharmacy Paediatrics)
View Full-Text   |   Download PDF [512 KB, uploaded 12 November 2015]   |  

Abstract

The lack of commercially-available pediatric drug products and dosage forms is well-known. A group of clinicians and scientists with a common interest in pediatric drug development and medicines-use systems developed a practical framework for identifying a list of active pharmaceutical ingredients (APIs) with the greatest market potential for development to use in pediatric patients. Reliable and reproducible evidence-based drug formulations designed for use in pediatric patients are needed vitally, otherwise safe and consistent clinical practices and outcomes assessments will continue to be difficult to ascertain. Identification of a prioritized list of candidate APIs for oral formulation using the described algorithm provides a broader integrated clinical, scientific, regulatory, and market basis to allow for more reliable dosage forms and safer, effective medicines use in children of all ages. Group members derived a list of candidate API molecules by factoring in a number of pharmacotherapeutic, scientific, manufacturing, and regulatory variables into the selection algorithm that were absent in other rubrics. These additions will assist in identifying and categorizing prime API candidates suitable for oral formulation development. Moreover, the developed algorithm aids in prioritizing useful APIs with finished oral liquid dosage forms available from other countries with direct importation opportunities to North America and beyond. View Full-Text
Keywords: compounded medications; formulation development; patient safety; pediatric compounded medications; formulation development; patient safety; pediatric
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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

Bhatt-Mehta, V.; MacArthur, R.B.; Löbenberg, R.; Cies, J.J.; Cernak, I.; II, R.H.P. An Algorithm to Identify Compounded Non-Sterile Products that Can Be Formulated on a Commercial Scale or Imported to Promote Safer Medication Use in Children. Pharmacy 2015, 3, 284-294.

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