Claims for Patent: 11,998,639

Summary for Patent: 11,998,639

Title:	Formulations of (R)-2-amino-3-phenylpropyl carbamate
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.
Inventor(s):	Clark Patrick Allphin, Edwin Gerard Walsh
Assignee:	Axsome Malta Ltd
Application Number:	US17/929,396
Patent Claims:	1. A solid pharmaceutical formulation for oral delivery of (R)-2-amino-3-phenylpropyl carbamate, comprising: a pharmaceutically acceptable salt of (R)-2-amino-3-phenylpropyl carbamate in an amount of about 90-98% by weight of the formulation; hydroxypropyl cellulose in an amount of 1-5% by weight of the formulation; and magnesium stearate in an amount of about 0.1-2% by weight of the formulation; wherein the formulation releases at least 85% of the pharmaceutically acceptable salt of (R)-2-amino-3-phenylpropyl carbamate contained therein within a period of less than 15 minutes after administration of the formulation to a subject; and wherein the formulation exhibits substantially identical dissolution rates of the pharmaceutically acceptable salt of (R)-2-amino-3-phenylpropyl carbamate at pH 1.2, pH 4.5, and pH 6.8; and wherein the formulation does not comprise a disintegrant. 2. The solid pharmaceutical formulation of claim 1, wherein the pharmaceutical formulation is a tablet. 3. The solid pharmaceutical formulation of claim 1, wherein the formulation releases at least 95% of the pharmaceutically acceptable salt of (R)-2-amino-3-phenylpropyl carbamate contained therein within a period of less than 15 minutes after administration of the formulation to a subject. 4. The solid pharmaceutical formulation of claim 1, further comprising a coating. 5. The solid pharmaceutical formulation of claim 4, wherein the coating is a color overcoat. 6. The solid pharmaceutical formulation of claim 1, wherein the pharmaceutically acceptable salt of (R)-2-amino-3-phenylpropyl carbamate is (R)-2-amino-3-phenylpropyl carbamate hydrochloride. 7. The solid pharmaceutical formulation of claim 1, wherein the formulation comprises about 300 mg of the pharmaceutically acceptable salt of (R)-2-amino-3-phenylpropyl carbamate. 8. The solid pharmaceutical formulation of claim 1, wherein the formulation comprises about 150 mg of the pharmaceutically acceptable salt of (R)-2-amino-3-phenylpropyl carbamate. 9. The solid pharmaceutical formulation of claim 1, wherein the formulation comprises about 75 mg of the pharmaceutically acceptable salt of (R)-2-amino-3-phenylpropyl carbamate. 10. The solid pharmaceutical formulation of claim 1, wherein the formulation comprises about 37.5 mg of the pharmaceutically acceptable salt of (R)-2-amino-3-phenylpropyl carbamate. 11. The solid pharmaceutical formulation of claim 1, comprising a pharmaceutically acceptable salt of (R)-2-amino-3-phenylpropyl carbamate in an amount of about 90-98% by weight of the formulation and a total weight of between about 30 to about 300 mg. 12. The solid pharmaceutical formulation of claim 1, comprising hydroxypropyl cellulose in an amount of about 1% to about 3% by weight of the formulation. 13. The solid pharmaceutical formulation of claim 1, comprising magnesium stearate in an amount of about 0.1% to about 1.0% by weight of the formulation. 14. The solid pharmaceutical formulation of claim 1, comprising hydroxypropyl cellulose in an amount of about 2% by weight of the formulation. 15. The solid pharmaceutical formulation of claim 1, comprising magnesium stearate in an amount of about 0.5% by weight of the formulation. 16. A method of treating narcolepsy, cataplexy, excessive daytime sleepiness, drug addiction, sexual dysfunction, fatigue, fibromyalgia, attention deficit/hyperactivity disorder, restless legs syndrome, depression, bipolar disorder, or obesity in a subject in need thereof, or promoting smoking cessation in a subject in need thereof, comprising administering to the subject solid pharmaceutical formulation for oral delivery of (R)-2-amino-3-phenylpropyl carbamate, the formulation comprising: a pharmaceutically acceptable salt of (R)-2-amino-3-phenylpropyl carbamate in an amount of about 90-98% by weight of the formulation; hydroxypropyl cellulose in an amount of 1-5% by weight of the formulation; and magnesium stearate in an amount of about 0.1-2% by weight of the formulation; wherein the formulation releases at least 85% of the pharmaceutically acceptable salt of (R)-2-amino-3-phenylpropyl carbamate contained therein within a period of less than 15 minutes after administration of the formulation to a subject; and wherein the formulation exhibits substantially identical dissolution rates of the pharmaceutically acceptable salt of (R)-2-amino-3-phenylpropyl carbamate at pH 1.2, pH 4.5, and pH 6.8; and wherein the formulation does not comprise a disintegrant. 17. The method claim 16, wherein the pharmaceutical formulation is a tablet. 18. The method claim 16, wherein the pharmaceutically acceptable salt of (R)-2-amino-3-phenylpropyl carbamate is (R)-2-amino-3-phenylpropyl carbamate hydrochloride. 19. The method of claim 16, wherein the formulation comprises between about 30 and about 300 mg of the pharmaceutically acceptable salt of (R)-2-amino-3-phenylpropyl carbamate.