Acamprosate formulations, methods of using the same, and combinations comprising the same
AssigneeSynchroneuron, LLC
InventorsBarry S. Fogel, William D. Kerns, Kei-Lai Fong
Life of this patent
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Abstract
Embodiments disclosed herein generally relate to acamprosate formulations, methods of use of the formulations, to methods of using the formulations in combination with at least one other medication, and to combination products and compositions comprising the formulations and at least one other medication, such as neuroleptic (antipsychotic) and/or antidepressant drugs.
Claims24
A method for administering a therapeutically effective amount of acamprosate to a subject, comprising administering to the subject acamprosate or a pharmaceutically acceptable salt thereof dispersed in a gastric retained dosage form to the subject in which a fed mode has been induced and wherein the dosage form comprises a single polymer matrix comprising at least one swellable hydrophilic polymer that swells in a dimensionally unrestrained manner by imbibing water to increase its size to promote gastric retention of the dosage form in the stomach of the subject, wherein upon contact with aqueous fluid, at least about 80% of the acamprosate in the extended release portion of the dosage form is released by the dosage form over a period of at least about 5 hours.
A method for treating a subject suffering from alcohol dependence comprising administering to the subject a total daily dose of about 300 to 2500 mg acamprosate or a pharmaceutically acceptable salt thereof dispersed in a polymeric matrix wherein the polymeric matrix comprises one or more polymers that upon imbibition of fluid swells to a size sufficient to promote gastric retention, wherein upon administration to the subject, the gastric retentive dosage form provides a mean AUC of plasma acamprosate greater than the mean AUC of plasma acamprosate provided by an immediate release (IR) dosage form which contains a dose of acamprosate or pharmaceutically acceptable salt thereof equal to or more than the dose of acamprosate in the gastric retentive dosage form.
A method of administering a therapeutically effective amount of a daily dose of acamprosate comprising administering acamprosate or a pharmaceutically acceptable salt thereof to a patient in need thereof, which patient has been induced to be in a fed mode, and the administered acamprosate is in a composition comprising a matrix comprising a polymer that swells within the stomach to a size sufficient so that it remains within the stomach, the polymer comprising a hydrophilic polymer, wherein the composition is formulated to release acamprosate at a controlled rate, and formulated to release at least 50% of the acamprosate within the stomach of the recipient within 4-8 hours of delivery.
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Dependencies are inferred from the claim text.