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BH4-RESPONSIVE HYPERPHENYLALANINEMIA REMEDIES
专利权人:
发明人:
申请号:
EP05739251.6
公开号:
EP1757293B1
申请日:
2005.05.11
申请国别(地区):
EP
年份:
2012
代理人:
摘要:
A pharmaceutical preparation containing sapropterin hydrochloride can be used to administer sapropterin hydrochloride, an effective therapeutic agent for the treatment of tetrahydrobiopterin-responsive hyperphenylalaninemia, to patients of a wide range of ages, ranging from infants to adults, in a single preparation. One specific example is a pharmaceutical preparation for the treatment of BH4-responsive hyperphenylalaninemia provided in the form of granule, fine granule, or dry syrup, comprising sapropterin hydrochloride as an active ingredient a flavoring agent a coloring agent which is stable to acid and oxidation and ascorbic acid or L-cysteine hydrochloride as a stabilizer, wherein the preparation has a moisture content (weight loss on drying) of 0.9% or less. Also provided is the pharmaceutical preparation in which the amount of sapropterin hydrochloride is from 2.5 to 20 wt%.
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