Back to results
US 2026/0007633 A1Published application
Liquid Tasimelteon Formulations and Methods of Use Thereof
AssigneeVanda Pharmaceuticals Inc.
InventorsDeepak Phadke, Mihael Polymeropoulos
Life of this patent
Estimating the term…
Abstract
Liquid suspensions of tasimelteon and methods for their use.
Claims20
A pharmaceutical composition comprising:
- an oral 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 orally administered;
- a suspending agent;
- 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 under ambient conditions.
4 more elements
A homogeneous aqueous suspension of tasimelteon comprising:
- tasimelteon;
- a suspending agent;
- and
- at least one additional component selected from a group consisting of:
- a sugar alcohol;
- a sweetening agent;
- a taste-masking agent;
- a flavoring agent;
- a preservative;
- a non-ionic surfactant;
- and
- an antioxidant,
- wherein the suspension satisfies one or more of the following release specifications:
- stability:
- following storage at 5±3° C., 25±2° C./60±5% RH and 40±2° C./75±5% RH for one, two, or three months, total impurities (HPLC) are not more than 1.5 wt % with respect to known impurities and not more than 0.2 wt % with respect to unspecified impurities;
- viscosity:
- 5 to 30 cps (ambient conditions);
- specific gravity:
- 1.1 to 1.3 mg/mL;
- pH:
- 4.0 to 5.0;
- particle size:
- D90=100 to 150 μm, D50=50 to 70 μm, and D10=15 to 40 μm
- dissolution:
- ≥90 following paddling for 15 minutes at 50 rpm in 1N HCl.
22 more elements
A homogeneous aqueous suspension of tasimelteon comprising:
- tasimelteon;
- a suspending agent;
- and
- at least one additional component selected from a group consisting of:
- a sugar alcohol;
- a sweetening agent;
- a taste-masking agent;
- a flavoring agent;
- a preservative;
- a non-ionic surfactant;
- and
- an antioxidant,
- wherein the particle size of the tasimelteon is:
- D
-
- 90
- <
- 200
-
- μm
- ;
- D
-
- 50
- <
- 100
-
- μm
- ;
- D
-
- 10
- <
- 50
-
- μm
- ;
- or
- D
-
- 90
- =
- 100
-
- to
-
- 150
-
- μm
- ;
- D
-
- 50
- =
- 50
-
- to
-
- 100
-
- μm
- ;
- D
-
- 10
- =
- 5
-
- to
-
- 50
-
- μm
- ;
- or
- D
-
- 90
- <
- 150
-
- μm
- ;
- D
-
- 50
- <
- 75
-
- μm
- ;
- D
-
- 10
- <
- 35
-
- μm
- ;
- or
- D
-
- 90
- =
- 100
-
- to
-
- 135
-
- μm
- ;
- D
-
- 50
- =
- 50
-
- to
-
- 75
-
- μm
- ;
- D
-
- 10
- =
- 20
-
- to
-
- 35
-
- μm
- .
133 more elements
A kit comprising:
- an aqueous suspension of tasimelteon;
- and
- instructions for the administration thereof to a patient, the instructions comprising:
- a first instruction to administer to a patient having a body mass of 28 kg or less a first dose of the aqueous suspension of tasimelteon equal to 0.7 mg/kg of tasimelteon;
- and
- a second instruction to administer to a patient having a body mass greater than 28 kg a second dose of the aqueous suspension of tasimelteon equal to 20 mg of tasimelteon.
3 more elements
Dependencies are inferred from the claim text.