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ICAN: Infant, Child, & Adolescent Nutrition
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In Vitro Stability of Sapropterin Dihydrochloride From Crushed Tablets Mixed in Applesauce, Pudding, and Infant Formula

Steven Striepeke

BioMarin Pharmaceutical Inc, Novato, California

Elaina R. Jurecki, MS, RD

BioMarin Pharmaceutical Inc, Novato, California

Carl S. Hornfeldt, PhD

BioMarin Pharmaceutical Inc, Novato, California

Sean Turbeville, PhD

BioMarin Pharmaceutical Inc, Novato, California, , sturbeville{at}bmrn.com

Bill Prince, PhD

BioMarin Pharmaceutical Inc, Novato, California

Sapropterin is approved to reduce blood phenylalanine levels in patients with hyperphenylalaninemia due to tetrahydrobiopterin-responsive phenylketonuria. The current Food and Drug Administration—approved labeling states that sapropterin tablets should be dissolved in 4 to 8 oz of water or apple juice; however, numerous requests for information regarding the feasibility of administering crushed sapropterin tablets in infant formula or soft foods such as applesauce and pudding suggest that the current recommendations for administration may not be suitable for many infants and small children. To determine the safety of administering the medication in formula or soft foods, powdered tablets representing 200 mg of sapropterin were thoroughly mixed with applesauce, lemon pudding, and 3 brands of phenylalanine-free infant formula, incubated for up to 60 minutes at room temperature and then analyzed for sapropterin content. The results indicate there was no significant change in the amount of sapropterin present in any mixture after 60 minutes.

Key Words: sapropterin • hyperphenylalaninemia • phenylketonuria • dosing • administration

ICAN: Infant, Child, & Adolescent Nutrition, Vol. 1, No. 5, 267-270 (2009)
DOI: 10.1177/1941406409347507
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