In Vitro Stability of Sapropterin Dihydrochloride From Crushed Tablets Mixed in Applesauce, Pudding, and Infant Formula

ICAN: Infant, Child, & Adolescent Nutrition

Volumn 1, Issue 5, 2009, Pages 267-270

  Striepeke, Steven ^a   Jurecki, Elaina R ^a   Hornfeldt, Carl S ^a   Turbeville, Sean ^a   Prince, Bill ^a  

^a BIOMARIN PHARMACEUTICAL INC   (United States)

Author keywords

administration; dosing; hyperphenylalaninemia; phenylketonuria; sapropterin

Indexed keywords

EID: 84997879860     PISSN: 19414064     EISSN: None     Source Type: Journal    
DOI: 10.1177/1941406409347507     Document Type: Article

References (7)

1. National Institutes of Health Consensus Development Panel. Phenylketonuria: screening and management, October 16-18, 2000. Pediatrics. 2001; 108: 972-982.
2. Waisbren SE, Noel K., Fahrbach K., et al. Phenylalanine blood levels and clinical outcomes in phenylketonuria: a systematic literature review and meta-analysis. Mol Genet Metab. 2007; 92: 63-70.
3. Burton BK, Grange DK, Milanowski A., et al. The response of patients with phenylketonuria and elevated serum phenylalanine to treatment with oral sapropterin dihydrochloride (6R-tetrahydrobiopterin): a phase II, multicentre, open-label, screening study. J Inherit Metab Dis. 2007; 30: 700-707.
4. Levy HL, Milanowski A., Chakrapani A., et al. Efficacy of sapropterin dihydrochloride (tetrahydrobiopterin, 6R-BH4) for reduction of phenylalanine concentration in patients with phenylketonuria: a phase III randomised placebo-controlled study. Lancet. 2007; 370: 504-510.
5. Kuvan [prescribing information]. Novato, CA: BioMarin Pharmaceutical; 2007.
6. Wells KA, Losin WG In vitro stability, potency, and dissolution of duloxetine enteric-coated pellets after exposure to applesauce, apple juice, and chocolate pudding. Clin Ther. 2008; 30: 1300-1308.
7. Carrier MN, Garinot O., Vitzling C. Stability and compatibility of tegaserod from crushed tablets mixed in beverages and foods. Am J Health Syst Pharm. 2004; 61: 1135-1142.