Acamprosate formulations, methods of using the same, and combinations comprising the same

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.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims is a continuation of PCT Application No. PCT / US2012 / 067507, filed on Dec. 2, 2012, entitled “ACAMPROSATE FORMULATIONS, METHODS OF USING THE SAME, AND COMBINATIONS COMPRISING THE SAME,” which claimed the benefit of priority under 35 U.S.C. §119(e) of U.S. Provisional Application No. 61 / 566,550 filed on Dec. 2, 2011, and U.S. Provisional Application No. 61 / 649,137, filed on May 18, 2012, both entitled “METHODS OF USING ACAMPROSATE FORMULATIONS AND COMPOSITIONS COMBINING ACAMPROSATE FORMULATIONS WITH NEUROLEPTIC DRUGS,” each of which is hereby incorporated herein by reference in its entirety and is to be considered a part of this specification.BACKGROUND[0002]1. Field[0003]Embodiments disclosed herein generally relate to methods of use of improved formulations of acamprosate (calcium N-acetylhomotaurinate) and to compositions and use of compositions comprising medications, such as neuroleptic (antipsychotic) and / or an...

AI Technical Summary

Benefits of technology

The patent text describes improved formulations of acamprosate, a drug used to treat neuropsychiatric disorders, that can provide better efficacy and tolerability with lower dosages and reduced side effects. The improved formulations can be used in fixed dose combinations with other medications, such as neuroleptic drugs, to treat various disorders with greater effectiveness and reduced risk of side effects. The fixed dose combinations can offer greater relief of symptoms and improve cognition in patients with pre-existing tardive dyskinesia. Overall, the patent text provides technical effects for improved treatment of neuropsychiatric disorders using acamprosate formulations.

Problems solved by technology

In particular, it reduces the response of the voltage-operated calcium channel to high levels of stimulation by glutamate.

The bioavailability of BCS Class III compounds tends to be low because the absorption of such compounds occurs either via diffusion—which is slow and inefficient because of the low permeability—or via specialized transporters in the membranes of intestinal mucosal cells—which may not exist, may poorly bind the compound, or may be easily saturated, implying zero-order kinetics.

Furthermore, even in embodiments where the GR system does not offer greater bioavailability—i.e., a larger area under the time-concentration curve (AUC) for a given oral dose—it can increase the efficacy of an oral dose by increasing the target site residence time at which the concentration exceeds a minimal threshold for efficacy.

In contrast with second-generation neuroleptics of equal therapeutic efficacy, these combinations can carry a lesser risk of significant metabolic disturbances including weight gain, glucose intolerance, and increased risk of atherosclerotic cardiovascular disease.

However, those drugs are no less efficacious in treating psychosis than the second-generation drugs (with the sole exception of clozapine), which usually are more expensive, and which have serious metabolic effects with potentially life-threatening consequences.

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