Pediatric drug development: formulation considerations.
Absence of safe, effective and appropriate treatment is one of the main causes of high mortality and morbidity rates among the pediatric group. This review provides an overview of pharmacokinetic differences between pediatric and adult population and their implications in pharmaceutical development. Different pediatric dosage forms, their merits and demerits are discussed. Food and Drug Administration Act of 1997 and the Best Pharmaceuticals for Children Act 2002 added 6 months patent extension and exclusivity incentives to pharmaceutical companies for evaluation of medicinal products in children. Prescription Drug User Fee Act and Food and Drug Administration Amendments Act of 2007 made it mandatory for pharmaceutical companies to perform pediatric clinical studies on new drug products. Drug development program should include additional clinical bridge studies to evaluate differences in pharmacokinetics and pharmacodynamics of drugs in adult and child populations. Additionally, pharmaceutical development should consider ease of administration, palatability, appropriate excipients, stability and therapeutic equivalency of pediatric dosage forms. Pediatric population is diverse with individual preferences and demand for custom made dosage formulations. Practically it is not feasible to have different pharmaceutical dosage forms for each group. Hence, an appropriate dosage form that can be administered across pediatric population is warranted.
Department of Clinical Pharmacy and Pharmacology, RAKCOPS, RAK Medical and Health Sciences University , Ras Al Khaimah , UAE .
Areeg Anwer
AA
Ali
Naseem Ahmad
NA
Charoo
Daud Baraka
DB
Abdallah
D000328:Adult; D000367:Age Factors; D000818:Animals; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D002648:Child; D002986:Clinical Trials as Topic; D004304:Dosage Forms; D004339:Drug Compounding / Q000379:methods; D015195:Drug Design; D005079:Excipients / Q000737:chemistry; D006801:Humans; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000737:chemistry; D010599:Pharmacokinetics; D014481:United States; D014486:United States Food and Drug Administration
D004304:Dosage Forms; D005079:Excipients; D004364:Pharmaceutical Preparations
Clinical studies; excipients; formulation development; pediatric formulations; pharmacokinetics; taste masking