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Publication Number
US-10874647-B2
Publication Date
2020-12-29
Expiration Date
Abstract
Provided herein are solid dispersions comprising rifaximin and pharmaceutical compositions and uses thereof.
Core Innovation
The disclosed subject matter relates to rifaximin solid dispersion formulations and pharmaceutical compositions. The formulations use HPMC-AS as an inert carrier and optionally include poloxamer 407, and solid dispersion and tablet dosage forms are described, including immediate release and sustained extended release embodiments.
The disclosure also describes pharmaceutical compositions as tablet dosage forms that include croscarmellose sodium, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate. The described embodiments include film coating and present dosage forms associated with rifaximin solid dispersion and soluble solid dispersion concepts.
A Phase 2 randomized, double-blind, placebo-controlled clinical study context is provided in early-decompensated cirrhosis. Outcomes include time to hospitalization for hepatic encephalopathy, esophageal variceal bleeding, spontaneous bacterial peritonitis, and hepatorenal syndrome, all-cause mortality, and time to development of medically refractory ascites.
Claims Coverage
Only one independent claim is provided. It recites a specific pharmaceutical composition having multiple quantitative component ranges and a defined total amount of rifaximin, and dependent claims further narrow the formulation to immediate release and tablet dosage forms.
Weight-percent rifaximin with defined carrier and excipients for a 40 mg total dose
A pharmaceutical composition containing from about 16 wt % to about 18 wt % rifaximin, from about 16 wt % to about 18 wt % HPMC-AS, from about 1 wt % to about 2 wt % poloxamer 407, from about 8 wt % to about 10 wt % croscarmellose sodium, from about 49 wt % to about 51 wt % microcrystalline cellulose, from about 0.15 wt % to about 0.25 wt % colloidal silicon dioxide, and from about 0.45 wt % to about 0.55 wt % magnesium stearate, wherein the total amount of rifaximin is 40 mg.
Immediate release pharmaceutical composition
The pharmaceutical composition is an immediate release composition.
Tablet dosage form
The pharmaceutical composition is formulated as a tablet.
The claim coverage is centered on a specifically quantified rifaximin/HPMC-AS-based pharmaceutical composition optionally including poloxamer 407, combined with croscarmellose sodium, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate, with the total rifaximin amount specified as 40 mg, and further narrowed to an immediate release tablet dosage form.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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