Acamprosate formulations, methods of using the same, and combinations comprising the same
AssigneeSynchroneuron, LLC
InventorsBarry S. Fogel, William D. Kerns, Kei-Lai Fong, San-Laung Chow, David Wong, Edward Lin
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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.
Claims43
1-66. (canceled)
In a method of administering acamprosate to a patient, the improvement that comprises:
- administering the acamprosate so that a steady-state in vivo acamprosate plasma concentration is maintained at or above a threshold value for time period of at least 4-10 hours of a 24 hour period, wherein the therapeutic threshold is about 100 ng/ml to about 500 ng/ml, with negligible GI side effects.
In a method of administering acamprosate to a patient, the improvement that comprises:
- administering the acamprosate via a formulation that includes a polymer matrix, which formulation is characterized in that, when tested in vitro, releases approximately 50% of the acamprosate within 2 hours and releases at least 80% of the acamprosate within 4-6 hours.
In a method of administering acamprosate to a patient, the improvement that comprises:
- administering the acamprosate via a formulation characterized in that, when tested in vitro, the formulation shows substantially equivalent in vitro acamprosate releasing profiles at pH 1.0 and pH 4.5.
A unit dose composition comprising:
- acamprosate within a range of 200 mg to about 3 grams;
- and
- a swelling polymer,
- which composition is characterized in that, when administered to a subject in a fasted state, achieves a plasma Cmax, a plasma Tmax, or a plasma AUC value that is similar to the corresponding value it achieves when administered to the same subject in a fed state.
A unit dose composition comprising:
- acamprosate within a range of 200 mg to about 3 grams;
- and
- a swelling polymer,
- which composition is characterized in that it has been demonstrated to achieve substantially similar plasma Cmax, plasma Tmax, or plasma AUC values when administered to subjects in a fed state as it achieves when administered to subjects in a fasted state.
A method comprising steps of:
- orally administering to a subject in a fasted state an acamprosate composition comprising acamprosate in a dose within the range of 400 mg-1500 mg.
A method comprising steps of:
- orally administering to a subject in a fasted state a pill comprising about 20-95% acamprostate, or a pharmaceutically acceptable salt thereof and about 1-30% of a carbomer polymer.
A method comprising steps of:
- orally administering to a subject in a fasted state an acamprosate pill comprising acamprosate in a dose within the range of 400 mg-1500 mg.
Dependencies are inferred from the claim text.