METHODS OF USING SOLUBLE SOLID DISPERSIONS OF RIFAXIMIN
Provided herein are solid dispersions comprising rifaximin and pharmaceutical compositions and uses thereof.
1 - 24 . (canceled)
25 . A method of increasing total fecal bile acid concentrations in a subject, comprising administering to said subject a soluble solid dispersion tablet comprising rifaximin, wherein after said administration to said patient, the total fecal bile acid concentrations increase within about 4 weeks.
26 . The method of claim 25 , wherein the tablet comprises about 40 mg rifaximin.
27 . The method of claim 25 , wherein the tablet further comprises HPMC-AS.
28 . The method of claim 25 , wherein the tablet comprises about 40 mg rifaximin and about 40 mg HPMC-AS.
29 . The method of claim 25 , wherein the total fecal bile acid concentrations increase by about 0.1-1.1 μmol/g.
30 . The method of claim 29 , wherein the total fecal bile acid concentrations increase by about 0.6 μmol/g.
31 . A method of increasing secondary fecal bile acid concentrations in a subject, comprising administering to said subject a soluble solid dispersion tablet comprising rifaximin, wherein after said administration to said patient, the secondary fecal bile acid concentrations increase within about 4 weeks.
32 . The method of claim 31 , wherein the tablet comprises about 40 mg rifaximin.
33 . The method of claim 31 , wherein the tablet further comprises HPMC-AS.
34 . The method of claim 31 , wherein the tablet comprises about 40 mg rifaximin and about 40 mg HPMC-AS.
35 . The method of claim 31 , wherein the secondary fecal bile acid concentrations increase by about 0.01-1.7 μmol/g.
36 . The method of claim 35 , wherein the secondary fecal bile acid concentrations increase by about 0.9 μmol/g.
37 . The method of claim 25 or 35 , wherein the subject has early decompensated cirrhosis.
38 . A method of treating a disease in a subject in need thereof, wherein treatment of the disease is effected by increasing the total and/or secondary bile acid concentrations in the subject, the method comprising administering a therapeutically effective dose of rifaximin to the subject in unit dosage form, wherein the unit dosage form consists of an immediate release soluble solid dispersion (SSD) tablet.
39 . The method of claim 38 , wherein the therapeutically effective dose of rifaximin is 40 mg of rifaximin.
40 . The method of claim 38 , wherein the rifaximin is delivered once daily to the subject.
41 . The method of claim 38 , wherein the rifaximin is delivered once daily to the subject for 24 weeks.
42 . The method of claim 38 , wherein the disease is selected from the group consisting of compromised gut microbial function, diabetes, irritable bowel syndrome, obesity, small intestinal bacterial overgrowth, alcoholism, colon cancer and adenomas, non-alcoholic fatty liver, cirrhosis, hepatic encephalopathy (HE), esophageal variceal bleeding (EVB), spontaneous bacterial peritonitis (SBP), and hepatorenal syndrome (HRS).
43 . The method of claim 42 , wherein the disease is selected from the group consisting of obesity, alcoholism, esophageal variceal bleeding (EVB), spontaneous bacterial peritonitis (SBP), and hepatorenal syndrome (HRS).
44 . The method of claim 43 , wherein the disease is obesity or alcoholism.