SOLID DISPERSION FORMS OF RIFAXIMIN
Provided herein are solid dispersions comprising rifaximin and pharmaceutical compositions and uses thereof.
1 - 35 . (canceled)
36 . A method of delaying the development of refractory ascites in a subject having liver cirrhosis, the method comprising administering to the subject 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.
37 . The method of claim 36 , wherein the immediate release pharmaceutical composition further comprises:
from about 1 wt % to about 2 wt % poloxamer 407;
from about 4 wt % to about 10 wt % croscarmellose sodium;
from about 49 wt % to about 55 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.
38 . The method of claim 37 , wherein the croscarmellose sodium is present in an amount from about 8 wt % to about 10 wt %.
39 . The method of claim 37 , wherein the croscarmellose sodium is present in an amount of about 9 wt %.
40 . The method of claim 37 , wherein the microcrystalline cellulose is present in an amount from about 49 wt % to about 51 wt %.
41 . The method of claim 37 , wherein the microcrystalline cellulose is present in an amount of about 51 wt %.
42 . The method of claim 37 , wherein the croscarmellose sodium is present in an amount from about 4 wt % to about 6 wt %.
43 . The method of claim 37 , wherein the croscarmellose sodium is present in an amount of about 5 wt %
44 . The method of claim 37 , wherein the microcrystalline cellulose is present in an amount from about 53 wt % to about 55 wt %.
45 . The method of claim 37 , wherein the microcrystalline cellulose is present in an amount of about 54 wt %.
46 . The method of claim 37 , wherein colloidal silicon dioxide is present in an amount of about 0.20 wt %.
47 . The method of claim 37 , wherein the magnesium stearate is present in an amount of about 0.50 wt %.
48 . The method of claim 36 , wherein the rifaximin is present in an amount of about 17 wt %.
49 . The method of claim 36 , wherein the HMPC-AS is present in an amount of about 17 wt %.
50 . The method of claim 36 , wherein the immediate release pharmaceutical composition is in the form of a tablet.
51 . The method of claim 36 , wherein, due to an inability of the subject to tolerate side effects of a maximal dose of diuretics, development of refractory ascites can no longer be effectively managed by: i) a low sodium diet and a maximal dose of diuretics; or ii) diuretics.
52 . The method of claim 51 , wherein the maximal dose of diuretics comprises up to 400 mg spironolactone and 160 mg furosemide per day.
53 . The method of claim 36 , the method comprising orally administering the immediate release pharmaceutical composition to the subject once per day.
54 . The method of 36 , the method comprising orally administering the immediate release pharmaceutical composition to the subject once per day at bedtime.
55 . The method of claim 36 , wherein the delaying of development of refractory ascites in the subject is for a period of time longer than the time to development of refractory ascites in a subject being administered an immediate release pharmaceutical composition comprising from 33 wt % to about 35 wt % rifaximin and from about 33 wt % to about 35 wt % HPMC-AS, wherein the total amount of rifaximin is 80 mg.