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Publication Number
US-11311521-B2
Publication Date
2022-04-26
Expiration Date
Abstract
Provided herein are solid dispersions comprising rifaximin and pharmaceutical compositions and uses thereof.
Core Innovation
The invention relates to rifaximin solid dispersions formulated with HPMC-AS, with optional poloxamer 407, to provide rifaximin pharmaceutical compositions for use in subjects having liver cirrhosis. The described compositions include immediate release and sustained extended release tablet dosage forms, with defined excipient sets for tablet cores and film coating, including Opadry II.
A method is described for preventing complications of liver disease by administering an immediate release pharmaceutical composition comprising rifaximin and HPMC-AS, with specified weight percentages and a total rifaximin amount. The complications targeted are selected from hepatic encephalopathy, esophageal variceal bleeding, spontaneous bacterial peritonitis, and hepatorenal syndrome.
The document defines targeted cirrhosis complications, including medically refractory ascites, and describes a Phase 2 randomized, double-blind, placebo-controlled study of rifaximin SSD tablets in early-decompensated liver cirrhosis. The study evaluates outcomes including time to hospitalization for HE/EVB/SBP/HRS or all-cause mortality, and time to development of medically refractory ascites.
Claims Coverage
The partial content provides one independent claim directed to a method of preventing selected complications of liver disease in subjects with liver cirrhosis. The claim includes key inventive features centered on specific rifaximin and HPMC-AS amounts in an immediate release composition and a defined set of targeted complications.
Preventing liver disease complications with specified rifaximin and HPMC-AS in immediate release composition
Administering to a subject having liver cirrhosis an immediate release pharmaceutical composition comprising rifaximin and HPMC-AS, with specified weight percentages and a total rifaximin amount of 40 mg.
Targeting HE, EVB, SBP, or HRS complications of liver disease
Preventing complications of liver disease selected from hepatic encephalopathy (HE), esophageal variceal bleeding (EVB), spontaneous bacterial peritonitis (SBP), and hepatorenal syndrome (HRS).
Overall, the independent claim is directed to preventing selected liver disease complications in subjects with liver cirrhosis by administering an immediate release composition with specified rifaximin and HPMC-AS weight ranges and a total rifaximin amount of 40 mg.
Stated Advantages
Statistically significant improvement in time to hospitalization for HE/EVB/SBP/HRS or all-cause mortality is reported.
Statistically significant improvements in time to development of medically refractory ascites are reported.
Documented Applications
Rifaximin SSD tablets are described for use in early-decompensated liver cirrhosis in a Phase 2 randomized, double-blind, placebo-controlled study, including outcomes related to HE/EVB/SBP/HRS, all-cause mortality, and medically refractory ascites.
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