Solid dispersion forms of rifaximin

Inventors

Golden, Pam • Kabir, Mohammed A.

Assignees

Salix Pharmaceuticals Inc

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Publication Number

US-11660292-B2

Patent

Publication Date

2023-05-30

Expiration Date


Abstract

Provided herein are solid dispersions comprising rifaximin and pharmaceutical compositions and uses thereof.

Core Innovation

The disclosure relates to an immediate release pharmaceutical composition comprising rifaximin and HPMC-AS. The composition comprises from about 16 wt % to about 18 wt % rifaximin and from about 16 wt % to about 18 wt % HPMC-AS.

The total amount of rifaximin in the immediate release pharmaceutical composition is 40 mg. The immediate release pharmaceutical composition is formulated for pharmaceutical use as a tablet.

Claims Coverage

The partial content contains one independent claim, covering a specifically defined immediate release rifaximin/HPMC-AS composition with a defined total rifaximin amount.

Immediate release composition with defined rifaximin and HPMC-AS amounts

An immediate release pharmaceutical composition comprising from about 16 wt % to about 18 wt % rifaximin and from about 16 wt % to about 18 wt % HPMC-AS, wherein the total amount of rifaximin is 40 mg.

Tablet formulation

The immediate release pharmaceutical composition of the defined rifaximin/HPMC-AS formulation is formulated as a tablet.

Overall, the claim coverage is limited to an immediate release pharmaceutical composition defined by wt % ranges of rifaximin and HPMC-AS and a total rifaximin amount of 40 mg, with further refinement to a tablet dosage form.

Stated Advantages

Documented Applications

Early decompensated cirrhosis with ascites, with clinical evaluation using Kaplan–Meier/time-to-event endpoints for hospitalization due to HE/EVB/SBP/HRS and/or all-cause mortality, and for time to development of medically refractory ascites.

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