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US 11,439,597 B2Granted
Formulations of (R)-2-amino-3-phenylpropyl carbamate
AssigneeAxsome Malta Ltd.
InventorsClark Patrick Allphin, Edwin Gerard Walsh
Life of this patent
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Abstract
The present invention relates to immediate release formulations of (R)-2-amino-3-phenylpropyl carbamate and methods of using the same to treat disorders.
Claims18
A solid pharmaceutical formulation for oral delivery of (R)-2-amino-3-phenylpropyl carbamate (APC) consisting of
- i) a pharmaceutically acceptable salt of APC containing 75 mg of APC;
- ii) a binder in an amount not exceeding 5% by weight of the formulation;
- iii) a lubricant in an amount of about 0.1-2% by weight of the formulation;
- and
- iv) an optional coating;
- wherein the formulation releases at least 85% of the pharmaceutically acceptable salt of APC in less than 15 minutes after oral administration of the formulation to a subject;
- and wherein the formulation exhibits substantially identical dissolution rates of the pharmaceutically acceptable salt of APC at pH 1.2, pH 4.5, and pH 6.8;
- wherein the binder is selected from hydroxypropyl cellulose, hydroxypropyl methylcellulose, and povidone;
- and
- wherein the lubricant is selected from magnesium stearate, calcium stearate, and sodium stearyl fumarate.
7 more elements
A solid pharmaceutical formulation for oral delivery of (R)-2-amino-3-phenylpropyl carbamate (APC) consisting of
- i) a pharmaceutically acceptable salt of APC containing 150 mg of APC;
- ii) a binder in an amount of about 1-5% by weight of the formulation;
- iii) a lubricant in an amount of about 0.1-2% by weight of the formulation;
- and
- iv) an optional coating;
- wherein the formulation releases at least 85% of the pharmaceutically acceptable salt of APC in less than 15 minutes after oral administration of the formulation to a subject;
- and wherein the formulation exhibits substantially identical dissolution rates of the pharmaceutically acceptable salt of APC at pH 1.2, pH 4.5, and pH 6.8;
- wherein the binder is selected from hydroxypropyl cellulose, hydroxypropyl methylcellulose, and povidone:
- wherein the lubricant is selected from magnesium stearate, calcium stearate, and sodium stearyl fumarate, and sodium stearyl fumarate.
6 more elements
Dependencies are inferred from the claim text.