Osmotic device containing alprazolam and an antipsychotic agent
AssigneeOsmotica Corp.
InventorsJoaquina Faour, Juan A. Vergez
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Abstract
The present invention provides an osmotic device containing controlled release alprazolam in the core optionally in combination with an anti-psychotic agent, in a rapid release external coat. A wide range of anti-psychotic agents can be used in this device. Particular embodiments of the invention provide osmotic devices having predetermined release profiles. One preferred embodiment of the osmotic device includes an external coat that has been spray coated rather compression coated onto the device. The device with spray coated external core is smaller and easier to swallow than the similar device having a compression coated external coat. The device is useful for the treatment of depression, anxiety or psychosis related disorders.
Claims29
An osmotic device for the delivery of alprazolam and an anti-psychotic agent comprising:
- a core comprising a therapeutically effective amount of alprazolam and at least one osmotic agent or osmopolymer;
- a semipermeable membrane surrounding the core and having a passageway there through;
- and
- an external coat comprising a therapeutically effective amount of an anti-psychotic agent;
- wherein the core provides a controlled release of APZ, and at least 60% of the APZ is released over an extended period of time of about 10 hours after exposure of the osmotic device to an aqueous solution, and the external coat provides a rapid release of the anti-psychotic agent, and at least 75% of the anti-psychotic agent is released within 1 hour after exposure of the osmotic device to an aqueous solution.
A controlled release dosage form comprising a first composition comprising a therapeutically effective amount of alprazolam, and a second composition comprising a therapeutically effective amount of an anti-psychotic agent, wherein the dosage form provides a controlled release of alprazolam and an immediate release of the anti-psychotic agent, and wherein at least 60% of the alprazolam is released over an extended period of time of about 10 hours after exposure of the dosage form to an aqueous solution and at least 75% of the anti-psychotic agent is released within about 1 hour after exposure of the dosage form to an aqueous solution.
Dependencies are inferred from the claim text.