Liquid tasimelteon formulations and methods of use thereof

Patent metadata

Field	Value
Publication number	US-12440470-B2
Application number	US-202318362194-A
Country	US
Kind code	B2
Filing date	Jul 31, 2023
Priority date	Dec 13, 2019
Publication date	Oct 14, 2025
Grant date	Oct 14, 2025

Abstract

Liquid suspensions of tasimelteon and methods for their use.

First claim

The invention claimed is:

1. A homogeneous aqueous suspension of tasimelteon, comprising:
1 to 6 mg/mL tasimelteon;
a suspending agent;
1 to 15 mg/mL HPMC;
200 to 400 mg/mL mannitol;
50 to 200 mg/mL sorbitol;
an antioxidant;
a preservative;
a high intensity sweetener; and
a flavoring agent.

2. A homogeneous aqueous suspension of tasimelteon, comprising:
1 to 6 mg/mL tasimelteon;
a suspending agent;
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.

3. A homogeneous aqueous suspension of tasimelteon, comprising:
1 to 6 mg/mL tasimelteon;
a suspending agent;
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.

Assignees

• Vanda Pharmaceuticals Inc

Inventors

• Phadke Deepak
• Polymeropoulos Mihael

Classifications

• A61K47/38

  Cellulose; Derivatives thereof · CPC title

• A61K47/26

  Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin · CPC title

• A61K47/10

  Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers · CPC title

• A61K47/02

  Inorganic compounds · CPC title

• A61K9/08

  Solutions {(composition of solutions A61K47/00)} · CPC title