Acamprosate formulations, methods of using the same, and combinations comprising the same
Inventors
Fogel, Barry S. • Kerns, William D. • Fong, Kei-Lai
Assignees
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Publication Number
US-9421179-B2
Publication Date
2016-08-23
Expiration Date
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.
Core Innovation
The patent describes a method of administering a therapeutically effective amount of acamprosate to a subject by administering a tablet. The tablet comprises acamprosate calcium or other pharmaceutically acceptable salt of acamprosate that is distributed within a polymer matrix, and the tablet further comprises carbomer homopolymer type B as part of the polymer matrix.
The patent frames the underlying goal as achieving therapeutically effective treatment of neuropsychiatric disorders by altering pharmacokinetics. It describes gastric-retentive controlled-release delivery intended to lower Cmax, delay Tmax, and increase time above threshold, enabling therapeutically effective treatment at sub-1 gram daily doses administered once or twice daily.
The patent additionally describes a fed-state inducing approach intended to enhance gastric retention using alpha-lipoic acid. It also describes translational support involving comparisons of GR versus enteric-coated approaches, as well as mechanistic and translational basis relating to persistent neuronal effects and receptor/transmission elements including GABA-A neurotransmission and NMDA-type glutamate receptors, as well as metabotropic glutamate receptors.
Claims Coverage
The provided independent claim content covers a single inventive feature set directed to an acamprosate tablet composition and its administration using a defined polymer matrix.
Therapeutically effective acamprosate tablet administration
A method of administering a therapeutically effective amount of acamprosate to a subject by administering a tablet.
Acamprosate calcium distributed within a polymer matrix
The tablet comprises acamprosate calcium or other pharmaceutically acceptable salt of acamprosate, distributed within a polymer matrix.
Carbomer homopolymer type B in the polymer matrix
The tablet comprises carbomer homopolymer type B as part of the polymer matrix.
Tablet amount including 800 mg acamprosate calcium
The tablet comprises 800 mg of acamprosate calcium or other pharmaceutically acceptable salt of acamprosate.
The claim coverage centers on administering acamprosate through a tablet containing acamprosate calcium or another pharmaceutically acceptable salt distributed within a polymer matrix that includes carbomer homopolymer type B, with the specified tablet amount.
Stated Advantages
Enables therapeutically effective treatment of neuropsychiatric disorders using altered pharmacokinetics (lower Cmax, delayed Tmax, and increased time above threshold).
Allows therapeutically effective treatment with sub-1 gram daily doses administered once or twice daily.
Documented Applications
Treating tardive dyskinesia.
Treating Tourette syndrome.
Treating obsessive-compulsive disorder (OCD).
Treating PTSD.
Treating schizophrenia.
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