Acamprosate formulations, methods of using the same, and combinations comprising the same
AssigneeSynchroneuron, LLC
InventorsBarry S. Fogel, William D. Kerns
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 optionally in combination with at least one other medication, and to combination products and compositions comprising acamprosate and at least one other medication, such as neuroleptic (antipsychotic) and/or antidepressant drugs.
Claims38
1-66. (canceled)
A tablet composition comprising:
- a polymer matrix comprised of at least one polymer;
- a dose of prazosin dispersed within the polymer matrix, the dose being within a range of about 0.1 mg to about 50 mg;
- and
- optionally at least one pharmaceutically acceptable excipient;
- the at least one polymer being selected, and the polymer matrix being present at a level within the tablet so that:
- when the tablet is exposed to a physiological buffer in vitro, it swells to a size within a range of between about 120% and about 150% of its initial size while remaining intact and firm.
A pharmaceutical composition comprising:
- a dose of prazosin within the range of 0.1 mg to 50 mg, present in a sustained release formulation that comprises a polymer matrix comprised of a polymer that it swells rather than dissolving when placed in contact with water, wherein
- the pharmaceutical composition is characterized in that it retains its integrity for at least several hours in an in vitro dissolution test, while releasing the prazosin either with zero-order kinetics or at a rate approximately linear with the square root of time, the releasing being substantially equivalent at pH 1.0 and pH 4.5.
A method comprising steps of:
- administering to a subject suffering from or susceptible to PTSD a combination of prazosin therapy and acamprosate therapy.
A method comprising steps of administering to a subject suffering from or susceptible to an anxiety disorder, PTSD, or insomnia, a combination of prazosin therapy and acamprosate therapy.
A method comprising steps of administering to a patient receiving prazosin therapy for PTSD, an anxiety disorder, or a sleep disorder, an acamprosate therapy regimen selected from the group consisting of:
- administration of acamprosate at a total daily dose between 1 gram and 4 grams per day, given as a single daily dose;
- administration of acamprosate in a pharmaceutical composition comprising a swelling polymer selected so that the acamprosate is released from the composition with either zero-order kinetics, first-order kinetics, or at a rate approximately proportional with the square root of time;
- and
- combinations thereof.
A method comprising steps of:
- administering acamprosate therapy to a subject receiving prazosin therapy.
A method of administering acamprosate to a subject receiving prazosin therapy, the method comprising administration of acamprosate at a total daily dose of 800 mg or more.
Dependencies are inferred from the claim text.