Formulations
AssigneeSynchroneuron, LLC
InventorsBarry S. Fogel, William D. Kerns, DVM, MS, DACVP, Kei-Lai Fong
Life of this patent
Estimating the term…
Abstract
Provided herein are high-dose formulations of acamprosate in a pharmaceutically acceptable salt form, as well as methods of preparing the same, and methods of using the same.
Claims122
In a method of manufacturing an oval uncoated tablet composition comprising acamprosate in a pharmaceutically acceptable salt form and a carbomer homopolymer, wherein the acamprosate is present in a dose of at least 400 mg and the composition is prepared by blending:
- (1) a preparation of granules with
- (2) extra-granular materials,
- the improvement that comprises including a cellulose derivative in each of (1) the preparation of granules, and (2) the extra-granular materials, so that the composition comprises:
- the acamprosate in a dose of about 66 wt % to about 72 wt %;
- the carbomer homopolymer in an amount of about 2 wt % to about 15 wt %;
- and
- the cellulose derivative in an amount of about 5 wt % to about 9 wt %.
An uncoated tablet composition comprising:
- acamprosate in a pharmaceutically acceptable salt form in a dose of about 66 wt % to about 72 wt %;
- carbomer homopolymer type B in an amount of about 3 wt % to about 7 wt %;
- a cellulose derivative in an amount of about 5 wt % to about 9 wt %;
- and
- optionally one or more pharmaceutically acceptable excipients.
An uncoated tablet composition comprising:
- acamprosate in a pharmaceutically acceptable salt form, in a dose of about 66 wt % to about 72 wt %;
- carbomer homopolymer type B in an amount of about 6 wt % to about 10 wt %;
- gelatin type B in an amount of about 2 wt % to about 5 wt %;
- and
- optionally one or more pharmaceutically acceptable excipients.
An uncoated tablet composition comprising:
- acamprosate in a pharmaceutically acceptable salt form, in a dose of about 66 wt % to about 72 wt %;
- carbomer homopolymer type C, in an amount of about 2 wt % to about 15 wt %;
- and
- optionally one or more pharmaceutically acceptable excipients.
A method of preparing an uncoated tablet composition comprising acamprosate in a pharmaceutically acceptable salt form, comprising:
- (i) blending a preparation of granules that comprises the acamprosate with extra-granular materials that comprise a carbomer homopolymer to form a blended material, wherein each of the granules and the extra-granular materials comprises a cellulose derivative material;
- and
- (ii) compressing the blended material to form the uncoated tablet composition.
Dependencies are inferred from the claim text.