FIELD: pharmaceuticals.
SUBSTANCE: group of inventions relates to the field of pharmaceuticals and medicine, namely, to a pressed tablet with immediate release and an oral dosage form with immediate release for oral delivery of (R)-2-amino-3-phenylpropyl carbamate, containing: 90 to 98 wt.% of (R)-2-amino-3-phenylpropyl carbamate or a pharmaceutically acceptable salt thereof; 1 to 5 wt.% of at least one binding agent; 0.1 to 1.4 wt.% of at least one lubricant; wherein at least 85% of (R)-2-amino-3-phenylpropyl carbamate or a pharmaceutically acceptable salt thereof is released from the tablet within less than 15 minutes after administration of the tablet to a subject; wherein the binding agent is selected from hydroxypropyl cellulose, hydroxypropyl methylcellulose, and povidone, and the lubricant is selected from magnesium stearate, calcium stearate, and sodium stearylfumarate. The group of inventions also relates to methods for treating narcolepsy, cataplexy, excessive daytime drowsiness, medication dependence, sexual dysfunction, fatigue, fibromyalgia, attention deficit/hyperactivity disorder, restless legs syndrome, depression, bipolar disorder, or obesity in a subject in need thereof, or assisting a subject in need thereof in quitting smoking, including administration of said tablet or dosage form to the subject.
EFFECT: group of inventions provides dosage forms with release of at least 85% of the active substance within 15 minutes at different values of pH.
31 cl, 4 dwg, 7 tbl, 2 ex
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Authors
Dates
2022-01-18—Published
2017-09-06—Filed