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US 12,605,386 B2Granted
Sapropterin formulation
AssigneeAPR Applied Pharma Research S.A.
InventorsChristopher Wagstaff, Stephen Tickle
Life of this patent
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Abstract
The present disclosure relates to a formulation of sapropterin. The formulation comprises a solid suspension of sapropterin dispersed within an oil. Methods of treatment using the formulation are also contemplated by the present disclosure.
Claims18
An oral suspension comprising:
- particulate sapropterin suspended in a liquid medium comprising i) a triglyceride comprising about 50% to about 80% caprylic acid triglyceride (C8) and about 20% to about 50% capric acid triglyceride (C10), and ii) a thickening agent,
- wherein the sapropterin is present in an amount from about 1 to about 50% w/v,
- wherein the suspension comprises a detectable amount of impurities but no more than about 1.5% of total impurities with respect to a peak area of sapropterin as measured by HPLC after 12 months of storage at 25° C. and 60% relative humidity or 40° C. and 75% relative humidity, and
- wherein the suspension is suitable for oral administration.
1 more element
Dependencies are inferred from the claim text.