AU2005239939C1 — BH4-responsive hyperphenylalaninemia remedies

USPTO Abstract

The invention aims at providing efficacious pharmaceutical preparations by which sapropterin hydrochloride effective in the treatment of tetrahydrobiopterin (BH4) -responsive hyperphenylalaninemia can be administered to a wide range of from infants to adults in the form of one preparation and which are excellent in the feelings in being administered and preservation stability. Specifically, sapropterin hydrochloride-containing granules, fine subtilaes, or dry syrups for the treatment of BH4-responsive hyperphenyl- alaninemia, characterized by containing a corrigent, a coloring agent stable to acids or oxidation, and a stabilizer consisting of ascorbic acid and L-cysteine hydrochloride and by having a water content (weight loss on drying) lowered to 0.9 % or below; and pharmaceutical preparations containing sapropterin hydrochloride as the active ingredient in amounts of 2.5 to 20 % by weight.