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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

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 (...

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Autores principales: Bhatt-Mehta, Varsha, MacArthur, Robert B., Löbenberg, Raimar, Cies, Jeffrey J., Cernak, Ibolja, Parrish, Richard H.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5597107/
https://www.ncbi.nlm.nih.gov/pubmed/28975916
http://dx.doi.org/10.3390/pharmacy3040284
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author Bhatt-Mehta, Varsha
MacArthur, Robert B.
Löbenberg, Raimar
Cies, Jeffrey J.
Cernak, Ibolja
Parrish, Richard H.
author_facet Bhatt-Mehta, Varsha
MacArthur, Robert B.
Löbenberg, Raimar
Cies, Jeffrey J.
Cernak, Ibolja
Parrish, Richard H.
author_sort Bhatt-Mehta, Varsha
collection PubMed
description 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.
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spelling pubmed-55971072017-09-29 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 Bhatt-Mehta, Varsha MacArthur, Robert B. Löbenberg, Raimar Cies, Jeffrey J. Cernak, Ibolja Parrish, Richard H. Pharmacy (Basel) Concept Paper 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. MDPI 2015-11-11 /pmc/articles/PMC5597107/ /pubmed/28975916 http://dx.doi.org/10.3390/pharmacy3040284 Text en © 2015 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Concept Paper
Bhatt-Mehta, Varsha
MacArthur, Robert B.
Löbenberg, Raimar
Cies, Jeffrey J.
Cernak, Ibolja
Parrish, Richard H.
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort algorithm to identify compounded non-sterile products that can be formulated on a commercial scale or imported to promote safer medication use in children
topic Concept Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5597107/
https://www.ncbi.nlm.nih.gov/pubmed/28975916
http://dx.doi.org/10.3390/pharmacy3040284
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