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

被引:5
作者
Bhatt-Mehta, Varsha [1 ,2 ,3 ]
MacArthur, Robert B. [4 ]
Loebenberg, Raimar [5 ,6 ]
Cies, Jeffrey J. [3 ,7 ,8 ]
Cernak, Ibolja [3 ,9 ]
Parrish, Richard H., II [3 ]
机构
[1] Univ Michigan, Sch Med, Dept Clin Social & Adm Sci, Coll Pharm, Ann Arbor, MI 48109 USA
[2] Univ Michigan, Sch Med, Dept Pediat, Ann Arbor, MI 48109 USA
[3] Med4Kids Res Collaborat Ltd, Edmonton, AB T6M 2J9, Canada
[4] Pharmaceut Int Inc, Clin Dev, Hunt Valley, MD 21031 USA
[5] Fac Pharm & Pharmaceut Sci, Div Pharmaceut Sci, Edmonton, AB T6G 2R3, Canada
[6] Univ Alberta, Drug Discovery & Innovat Ctr, Edmonton, AB T6G 2R3, Canada
[7] Drexel Univ, Coll Med, Philadelphia, PA 19129 USA
[8] St Christophers Hosp Children, Philadelphia, PA 19140 USA
[9] Univ Alberta, Mil & Vet Clin Rehabil Res, Edmonton, AB T6G 2G4, Canada
关键词
compounded medications; formulation development; patient safety; pediatric;
D O I
10.3390/pharmacy3040284
中图分类号
R9 [药学];
学科分类号
1007 ;
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.
引用
收藏
页码:284 / 294
页数:11
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