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

Varsha Bhatt-Mehta³  Robert B. MacArthur⁴  Raimar Lnberg¹  Jeffrey J. Cies²  Ibolja Cernak²  Richard H. Parrish² 

[1] Pharmaceutical Sciences Division, Faculty of Pharmacy and Pharmaceutical Sciences, Edmonton, AB, T6G 2R3, Canada; E-Mail:;Med4Kids Research Collaborative, Ltd., Edmonton, AB, T6M 2J9, Canada; E-Mails:;Department of Clinical, Social and Administrative Sciences, College of Pharmacy and Department of Pediatrics, Medical School, University of Michigan, Ann Arbor, MI, 48109, USA;Clinical Development, Pharmaceutics International, Inc., Hunt Valley, MD, 21031, USA; E-Mail:

关键词: compounded medications;    formulation development;    patient safety;    pediatric;   

DOI  :  10.3390/pharmacy3040284

来源: mdpi

【 摘 要 】

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.

【 授权许可】

CC BY   
© 2015 by the authors; licensee MDPI, Basel, Switzerland.