Methods of treatment and formulations of cephalosporin
View Patent ↗Formulations containing an antibacterial alkali metal salt of a cephalosporin compound and methods of treating bacterial infections in dogs and cats.
1. A lyophilized pharmaceutical composition comprising a compound of Formula I,
wherein M + is Na + , an optional pharmaceutically acceptable buffer, and a pharmaceutically acceptable preservative selected from methyl paraben, propyl paraben, or a combination of methyl and propyl parabens, wherein the aqueous composition, prior to lyophilization, has a pH of 6.0 to 7.5, and wherein the composition after lyophilization has a residual water content of less than 1% by weight, based on the weight of the lyophile.
2. A composition according to claim 1 , wherein the buffer is a citrate buffer.
3. A kit comprising:
a) a therapeutically effective amount of a lyophilized pharmaceutical composition comprising a compound of Formula I,
wherein M + is N + , an optional pharmaceutical buffer, and a preservative selected from methyl paraben, propyl paraben, or a combination of methyl and propyl parabens, wherein the aqueous composition, prior to lyophilization, has a pH of 6.0 to 7.5, and wherein the composition after lyophilization has a residual water content of less than 1 by weight, based on the weight of the lyophile;
b) an aqueous pharmaceutically acceptable diluent; and
c) a first and second container for containing the composition (a) and the diluent (b), wherein the first container is adapted to receive the diluent from the second container.
4. A composition according to claim 1 wherein the composition after lyophilization has a residual water content of less than 0.5% by weight, based on the weight of the lyophile.
5. A composition according to claim 4 , wherein the buffer is a citrate buffer.
6. A kit comprising:
a) a therapeutically effective amount of a lyophilized pharmaceutical composition comprising a compound of Formula I;
wherein M + is Na + , an optional pharmaceutical buffer, and a preservative selected from methyl paraben, propyl paraben, or a combination of methyl and propyl parabens, wherein the aqueous composition, prior to lyophilization, has a pH of 6.0 to 7.5, and wherein the composition after lyophilization has a residual water content of less than 0.5% by weight, based on the weight of the lyophile;
b) an aqueous pharmaceutically acceptable diluent; and
c) a first and second container means for containing the composition (a) and the diluent (b), wherein the first container is adapted to receive the diluent from the second container.