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US 2025/0049722 A1Published application
Tripulse release stimulant formulations
AssigneeCingulate Therapeutics LLC
InventorsMatthew Brams, Raul Silva, Arthur Straughn
Life of this patent
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Abstract
A single dosage form that delivers a tripulse (i.e., three pulses) release profile is provided. The dosage form includes at least three dosage units inside the final dosage form. By providing a single dosage form with multiple dosage units, the dosing frequency is decreased since precise blood levels of the active over a prolonged time period are controlled and achieved.
Claims13
A pulsatile release dosage form for oral administration of a stimulant, comprising
- (a) a first dosage unit comprising a first stimulant dose that is released substantially immediately following oral administration of the dosage form to a patient;
- (b) a second dosage unit comprising a second stimulant dose, wherein the second stimulant dose is delayed until about 3 to about 4 hours following administration of the dosage form to a patient;
- and
- (c) a third dosage unit comprising a third stimulant dose, wherein the third stimulant dose is delayed until about 6 to about 8 hours following oral administration of the dosage form to a patient;
- wherein the first, second and third dosage units are incorporated at specific and controlled positions within the finished dosage form;
- and,
- wherein the stimulant is methylphenidate or amphetamine, or a pharmaceutically acceptable salt thereof.
4 more elements
A method of treatment of a disorder, condition or disease for which a stimulant is generally indicated, the method comprising the steps of
- administering a pharmaceutically acceptable amount of a once-daily dosage form, the dosage form comprising
- (a) a first dosage unit comprising a first stimulant dose that is released substantially immediately following oral administration of the dosage form to a patient;
- (b) a second dosage unit comprising a second stimulant dose, wherein the second stimulant dose is delayed until about 3 to about 4 hours following administration of the dosage form to a patient;
- and
- (c) a third dosage unit comprising a third stimulant dose, wherein the third stimulant dose is delayed until about 6 to about 8 hours following oral administration of the dosage form to a patient;
- wherein the first, second and third dosage units are incorporated at specific and controlled positions within the finished dosage form;
- and,
- wherein the stimulant is methylphenidate or amphetamine, or a pharmaceutically acceptable salt thereof.
5 more elements
Dependencies are inferred from the claim text.