Claims for Patent: 11,202,770

Summary for Patent: 11,202,770

Title:	Liquid tasimelteon formulations and methods of use thereof
Abstract:	Liquid suspensions of tasimelteon and methods for their use.
Inventor(s):	Phadke; Deepak (Olathe, KS), Polymeropoulos; Mihael (Potomac, MD)
Assignee:	VANDA PHARMACEUTICALS INC. (Washington, DC)
Application Number:	17/119,953
Patent Claims:	1. A pharmaceutical composition comprising: a homogeneous aqueous suspension of tasimelteon at a concentration such that one or more unit doses, with a volume of 0.35 mL to 10 mL, contain an amount of tasimelteon effective to treat an individual to whom the unit dose or doses is administered; a suspending agent comprising microcrystalline cellulose and sodium carboxymethyl cellulose at a concentration of: 10 to 30 mg/mL; or 10 to 20 mg/mL; or 20 mg/mL; a taste-masking agent; an opacity-imparting agent; and a surfactant, wherein the composition has a viscosity less than or equal to 150 cps and a specific gravity of greater than 1-1.5 under ambient conditions, and wherein the tasimelteon is present at a concentration of: 1 to 6 mg/mL; or 2 to 5 mg/mL; or 1 mg/mL; or 4 mg/mL. 2. The composition of claim 1, wherein the suspending agent further includes at least one cellulosic suspending agent selected from a group consisting of: methylcellulose, hydroxypropyl methylcellulose (HPMC), and sodium carboxypropylmethylcellulose (CPMC). 3. The composition of claim 1, wherein the opacity-imparting agent is mannitol. 4. The composition of claim 1, wherein the taste-masking agent is a sweetener selected from a group consisting of: monosaccharides, disaccharides, and high-intensity sweeteners. 5. The composition of claim 4, wherein the sweetener is sucrose. 6. The composition of claim 5, wherein the total solids content is less than 500 mg/mL. 7. The composition of claim 4, wherein the high-intensity sweetener is selected from a group consisting of: stevia, aspartame, sucralose, neotame, acesulfame potassium, saccharin, advantame, and a cyclamate. 8. The composition of claim 1, wherein the surfactant is a non-ionic surfactant. 9. The composition of claim 8, wherein the non-ionic surfactant is polysorbate 80. 10. The composition of claim 9, wherein the polysorbate 80 is present in an amount of 0.5 to 5 mg/mL, or 1 to 3 mg/mL, or 1 to 2 mg/mL, or about 1 mg/mL. 11. A homogeneous aqueous suspension of tasimelteon comprising: 1 to 6 mg/mL tasimelteon; 1 to 15 mg/mL hydroxypropylmethylcellulose; 200 to 400 mg/mL mannitol; 50 to 200 mg/mL sorbitol; a high intensity sweetener; a flavoring agent; a preservative; and an antioxidant. 12. The composition of claim 11, wherein the particle size of the tasimelteon is: D.sub.90<200 .mu.m; D.sub.50<100; D.sub.10<50 .mu.m; or D.sub.90=100 to 150 .mu.m; D.sub.50=50 to 100 .mu.m; D.sub.10=5 to 50 .mu.m; or D.sub.90<150 .mu.m; D.sub.50<75 .mu.m; D.sub.10<35 .mu.m; or D.sub.90=100 to 135 .mu.m; D.sub.50=50 to 75 .mu.m; D.sub.10=20 to 35 .mu.m. 13. A homogeneous aqueous suspension of tasimelteon comprising: 1 to 6 mg/mL tasimelteon; 5 to 40 mg/mL microcrystalline cellulose and sodium carboxymethylcellulose; 100 to 400 mg/mL mannitol; 200 to 400 mg/mL sucrose; 1 to 10 mg/mL NaCl; an antioxidant; a preservative; and a flavoring agent. 14. A homogeneous aqueous suspension of tasimelteon comprising: 1 to 6 mg/mL tasimelteon; 10 to 20 mg/mL microcrystalline cellulose and carboxymethylcellulose sodium; 100 to 200 mg/mL mannitol; 250 to 350 mg/mL sucrose; 2 to 8 mg/mL NaCl; an antioxidant; a preservative; and a flavoring agent.