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US 2025/0222004 A1Published application
Formulations of viloxazine
AssigneeSupernus Pharmaceuticals, Inc.
InventorsMichael L. Vieira, Austin B. Huang, Padmanabh P. Bhatt
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Abstract
Modified release formulations of viloxazine and methods of administering the same are disclosed. High-drug load formulations of viloxazine are further disclosed.
Claims26
A method of treating ADHD in a human patient, comprising administering once a day to said patient a pharmaceutical formulation, comprising
- (a) an immediate release (IR) component comprising viloxazine or a salt thereof and, optionally, a pharmaceutically acceptable excipient, and
- (b) a delayed release (DR) component comprising (i) viloxazine or a salt thereof, (ii) an extended release (XR) matrix having viloxazine or a salt thereof and at least one release rate controlling compound, (iii) a layer comprising an enteric compound surrounding the matrix,
- wherein the viloxazine or salt thereof in the DR component of the formulation is released when the formulation is exposed to a pH of 4.5 or above,
- wherein the formulation comprises an amount of viloxazine effective to treat ADHD in a human patient when administered to the human patient once per day;
- and
- wherein viloxazine is the sole active pharmaceutical ingredient of the pharmaceutical formulation.
3 more elements
A method of treating ADHD in a human patient, comprising administering once a day to said patient a pharmaceutical formulation, comprising
- (a) an immediate release (IR) component comprising an inert core and a layer comprising viloxazine or a salt thereof and, optionally, a pharmaceutically acceptable excipient, surrounding the core, and
- (b) a delayed release (DR) component comprising:
- (i) an inert core, (ii) a first layer comprising viloxazine or a salt thereof and, optionally, a pharmaceutically acceptable excipient, surrounding the core, and (iii) a second layer comprising at least one release rate controlling compound surrounding the first layer, and (iv) a third layer comprising an enteric compound surrounding the second layer,
- wherein the viloxazine or salt thereof in the DR component of the formulation is released when the formulation is exposed to a pH of 4.5 or above,
- wherein the formulation comprises an amount of viloxazine effective to treat ADHD in a human patient when administered to the human patient once per day;
- and
- wherein viloxazine is the sole active pharmaceutical ingredient of the pharmaceutical formulation.
4 more elements
Dependencies are inferred from the claim text.