Pediatric drugs--a review of commercially available oral formulations.
Pediatric oral formulations can be quite scientifically challenging to develop and the prerequisites for both a measurable dosage form to administer based upon bodyweight, and also taste-masking are two of the challenges unique for pediatric oral formulations. The physicochemical and organoleptic properties of the active drug substance such as solubility, chemical stability, and taste along with the intended dose can determine which formulations are feasible to develop. Oral pediatric formulations are available in 17 different varieties and can be either a ready-to-use formulation such as a solution, syrup, suspension, tablet, scored tablet, chewable tablet, orally disintegrating tablet, or thin strip, or can also be a formulation that requires manipulation such as a powder for constitution to a suspension, tablet for constitution to a suspension, powder for constitution to a solution, drops for reconstitution to a suspension, concentrated solution for dilution, effervescent tablet, bulk oral granules, bulk oral powder, or solid in a capsule to mix with food or drink. Recently there has been an increase in pediatric formulation development inspired by increased regulatory incentives. The intent of this review is to educate the reader on the various types of formulations administered orally to pediatrics, the rationale in deciding which type of formulation to develop, the excipients used, development challenges, the in-use handling of oral pediatric formulations, and the regulatory incentives.
Strickley
Robert G
RG
Formulation and Process Development, Gilead Sciences, Inc. 333 Lakeside Drive, Foster City, California 94404, USA. rstrickley@gilead.com
Iwata
Quynh
Q
Wu
Sylvia
S
Dahl
Terrence C
TC
D000284:Administration, Oral; D002626:Chemistry, Pharmaceutical; D002648:Child; D006801:Humans; D010372:Pediatrics; D013535:Suspensions; D013607:Tablets