COMPOSITIONS COMPRISING FUSIDIC ACID AND PACKAGES THEREFOR
Described are solid pharmaceutical compositions of fusidic acid, and pharmaceutically acceptable salts thereof, dosage units of the pharmaceutical compositions, and packages for pharmaceutical compositions of fusidic acid, and pharmaceutically acceptable salts thereof, which increase stability against the degradation of the fusidic acid, and pharmaceutically acceptable salts thereof. Also described are uses of the pharmaceutical compositions and dosage units in treating diseases.
1 . A solid pharmaceutical composition comprising fusidic acid, or a pharmaceutically acceptable salt thereof, and mannitol.
2 . The pharmaceutical composition of claim 1 wherein the w/w ratio of the fusidic acid or salt thereof to mannitol is in the range from about 1:1 to about 10:1.
3 .- 4 . (canceled)
5 . A dosage unit comprising the solid pharmaceutical composition of claim 1 , where the fusidic acid or salt thereof is present in the range from about 275 mg to about 1,000 mg.
6 .- 9 . (canceled)
10 . The dosage unit of claim 5 wherein the w/w ratio of the fusidic acid or salt thereof to mannitol is in the range from about 1:1 to about 10:1.
11 .- 12 . (canceled)
13 . The dosage unit of claim 5 wherein the fusidic acid or salt thereof is present at about 10% to about 90% by weight.
14 . The dosage unit of claim 5 wherein the fusidic acid or salt thereof is present at about 40% to about 60% by weight.
15 . A packaged article comprising a container and the pharmaceutical composition of claim 1 wherein the pharmaceutical composition or the dosage unit is inside the container and wherein the container is an oxygen resistant and/or oxygen impermeable container.
16 . A packaged article comprising a container and the pharmaceutical composition of claim 1 wherein the pharmaceutical composition or the dosage unit is inside the container and wherein the container or package includes an antioxidant compound or composition.
17 . A packaged article comprising a container and the pharmaceutical composition of claim 1 wherein the pharmaceutical composition or the dosage unit is inside the container and wherein the container or package includes an atmosphere with reduced oxygen or an atmosphere that is substantially free of oxygen.
18 . (canceled)
19 . A packaged article comprising a container and a pharmaceutical composition or dosage unit, wherein the pharmaceutical composition or the dosage unit is inside the container, and wherein the pharmaceutical composition or the dosage unit comprises fusidic acid, or a pharmaceutically acceptable salt thereof, or a combination thereof, where the fusidic acid, salt thereof, or a combination thereof degrades by about 10% or less after 24 months at 25° C. and 60% RH.
20 . The article of claim 19 wherein the assay value of the fusidic acid or salt thereof is about 90% or more after 24 months at 25° C. and 60% RH.
20 .- 25 . (canceled)
26 . The article of claim 19 wherein the assay value of the fusidic acid or salt thereof is about 90% or more after 12 months at 40° C. and 75% RH.
27 .- 31 . (canceled)
32 . The article of claim 19 wherein the amount of 27-oxofusidic acid increases by less than about 2-fold after prolonged storage under ambient conditions.
33 .- 34 . (canceled)
35 . The article of claim 19 wherein the amount of 3-ketofusidic acid increases by less than about 2-fold after prolonged storage under ambient conditions.
36 .- 37 . (canceled)
38 . The article of claim 19 wherein the amount of 16-desacetylfusidic acid-21,16-lactone increases by less than about 2-fold after prolonged storage under ambient conditions.
39 .- 40 . (canceled)
41 . The article of claim 19 wherein the amount of epi-16-desacetylfusidic acid increases by less than about 2-fold after prolonged storage under ambient conditions.
42 .- 45 . (canceled)
46 . The article of claim 19 wherein the composition further comprises mannitol.
47 .- 53 . (canceled)
54 . A packaged article comprising a container and a dosage unit, wherein the dosage unit is inside the container, and wherein the dosage unit comprises a pharmaceutical composition comprising fusidic acid, or a pharmaceutically acceptable salt thereof, or a combination thereof, where the fusidic acid, salt thereof, or a combination thereof degrades by about 10% or less after 18 months at 25° C. and 60% RH.
55 . (canceled)
56 . The article of claim 54 where the fusidic acid, salt thereof, or a combination thereof degrades by about 10% or less after 9 months at 40° C. and 75% RH.
57 . (canceled)
58 . A method for treating a bacterial infection in a host animal, the method comprising the step of administering to the host animal a therapeutically effective amount of the pharmaceutical composition of claim 1 .
59 .- 61 . (canceled)