Sapropterin Dihydrochloride Mixed With Common Foods and Beverages.
Sapropterin dihydrochloride is used to lower blood phenylalanine levels in tetrahydrobiopterin-responsive phenylketonuria in conjunction with a phenylalanine-restricted diet. This study investigated the solubility and stability of sapropterin tablets and a sapropterin powder formulation when mixed in selected beverages and foods. Solubility was partial for the tablets and complete for the powder. The stability testing showed that 93% or more of active sapropterin dihydrochloride is present at 1 hour after either tablets or powders are mixed with certain foods and beverages. Mixing sapropterin powder with foods and beverages might facilitate its administration in patients who have difficulty swallowing the drug according to prescribing information.
Medical Affairs (Ms Jurecki, Messrs Mahoney and James, and Dr Cohen-Pfeffer) and Quality and Process Development (Messrs Tingley and Chung), BioMarin Pharmaceutical, Inc, Novato, California; and Hayward Genetics Center, Tulane University School of Medicine, New Orleans, Louisiana (Ms Cunningham).
Elaina R
ER
Jurecki
Medical Affairs (Ms Jurecki, Messrs Mahoney and James, and Dr Cohen-Pfeffer) and Quality and Process Development (Messrs Tingley and Chung), BioMarin Pharmaceutical, Inc, Novato, California; and Hayward Genetics Center, Tulane University School of Medicine, New Orleans, Louisiana (Ms Cunningham).
Amy
A
Cunningham
Medical Affairs (Ms Jurecki, Messrs Mahoney and James, and Dr Cohen-Pfeffer) and Quality and Process Development (Messrs Tingley and Chung), BioMarin Pharmaceutical, Inc, Novato, California; and Hayward Genetics Center, Tulane University School of Medicine, New Orleans, Louisiana (Ms Cunningham).
John J
JJ
Mahoney
Medical Affairs (Ms Jurecki, Messrs Mahoney and James, and Dr Cohen-Pfeffer) and Quality and Process Development (Messrs Tingley and Chung), BioMarin Pharmaceutical, Inc, Novato, California; and Hayward Genetics Center, Tulane University School of Medicine, New Orleans, Louisiana (Ms Cunningham).
Douglas
D
Tingley
Medical Affairs (Ms Jurecki, Messrs Mahoney and James, and Dr Cohen-Pfeffer) and Quality and Process Development (Messrs Tingley and Chung), BioMarin Pharmaceutical, Inc, Novato, California; and Hayward Genetics Center, Tulane University School of Medicine, New Orleans, Louisiana (Ms Cunningham).
Stanley
S
Chung
Medical Affairs (Ms Jurecki, Messrs Mahoney and James, and Dr Cohen-Pfeffer) and Quality and Process Development (Messrs Tingley and Chung), BioMarin Pharmaceutical, Inc, Novato, California; and Hayward Genetics Center, Tulane University School of Medicine, New Orleans, Louisiana (Ms Cunningham).
Neil
N
James
Medical Affairs (Ms Jurecki, Messrs Mahoney and James, and Dr Cohen-Pfeffer) and Quality and Process Development (Messrs Tingley and Chung), BioMarin Pharmaceutical, Inc, Novato, California; and Hayward Genetics Center, Tulane University School of Medicine, New Orleans, Louisiana (Ms Cunningham).
Jessica L
JL
Cohen-Pfeffer
phenylalanine; phenylketonuria; sapropterin; tetrahydrobiopterin