Stable parenteral DNJ compositions
AssigneeAmicus Therapeutics, Inc.
InventorsHing Char, Sergey Tesler, Jiping Yang, Enrique Dilone
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Abstract
A stable pharmaceutical composition that includes an active agent selected from 1-deoxynojirimycin, a pharmaceutically acceptable salt thereof, or a derivative thereof, and a buffer, wherein the stable pharmaceutical composition is capable of being parenterally administered to a human without deleterious health effects. Pompe disease is an example of a lysosomal storage disorder. Pompe disease is caused by a deficiency in the enzyme acid alpha-glucosidase (GAA). GAA metabolizes glycogen, a storage form of sugar used for energy, into glucose.
Claims20
A pharmaceutical composition comprising:
- a) an active agent selected from 1-deoxynojirimycin, a pharmaceutically acceptable salt thereof, or a derivative thereof, and
- b) a buffer,
- wherein the active agent is present at a concentration of from about 1 mg/mL to about 100 mg/mL.
A pharmaceutical composition comprising
- a) an active agent comprising N -butyl-deoxynojirimycin, or a pharmaceutically acceptable salt thereof , and
- b) a buffer,
- wherein the active agent is present at a concentration of from about 1 mg/mL to about 100 mg/mL and the buffer is present at a concentration of about 20 mM to about 75 mM.
A method for increasing the stability of a formulation comprising an active agent selected from 1-deoxynojirimycin, a pharmaceutically acceptable salt thereof, or a derivative thereof, the method comprising introducing a buffer into the formulation, wherein the active agent is present at a concentration of from about 1 mg/ml to about 100 mg/mL.
Dependencies are inferred from the claim text.