Cefazolin suspension for parenteral administration

Claim 1

A pharmaceutical suspension for parenteral administration comprising from about 10 to about 65 percent (W/V) of cefazolin, from about 0.1 to about 1.0 percent of lecithin, from about 0.1 to about 1.0 percent (W/V) of a pharmaceutically acceptable surfactant, from about 0.1 to about 2.0 percent (W/V) of a viscosity adjusting agent selected from the group consisting of povidone and sodium carboxymethylcellulose or a combination thereof, and water for injection q.s. to 100 percent by volume.

Claim 12

A method of preparing a storage stable pharmaceutical suspension of cefazolin for parenteral administration comprising: a. combining, with agitation, from about 0.1 to about 1.0 parts by weight of a pharmaceutically acceptable surfactant with about 35 parts by volume of water for injection, U.S.P., said water having been previously heated to about 80° C.; b. adding to the preparation from a), with agitation, from about 0.1 to about 1.0 parts by weight of lecithin; c. adding to the preparation from b), with agitation, from about 0.1 to about 2.0 parts by weight of a viscosity adjusting agent selected from the group consisting of povidone and sodium carboxymethylcellulose or combination thereof; d. sterilizing the preparation from c) by autoclaving for about 60 minutes at 115° to 125° C. and 20 psig; e. cooling the preparation from d) to room temperature; f. adding to the preparation from e), with agitation, from about 10 to about 65 parts by weight of cefazolin previously reduced to a particle size wherein at least 80 percent are <10 μm and all are <100 μm; and g. adding to the preparation from f), with agitation, sufficient sterile water for injection, U.S.P. to q.s. said suspension to 100 party by volume.

Claim 13

A method of preparing a storage stable pharmaceutical suspension of cefazolin for parenteral administration comprising: a. combining, with agitation, from about 0.1 to about 1.0 parts by weight of a pharmaceutically acceptable surfactant with about 35 parts by volume of water for injection, U.S.P., said water having been previously heated to about 80° C.; b. adding to the preparation from a), with agitation, from about 0.1 to about 1.0 parts by weight of lecithin; c. adding to the preparation from b), with agitation, from about 0.1 to about 2.0 parts by weight of a viscosity adjusting agent selected from the group consisting of povidone and sodium carboxymethylcellulose or combination thereof; d. sterilizing the preparation from c) by autoclaving for about 60 minutes at 115° to 125° C. and 20 psig; e. cooling the preparation from d) to room temperature; f. adding to the preparation from e), with agitation, from about 10 to about 65 parts by weight of cefazolin previously reduced to a particle size wherein at least 80 percent are <10 μm and all are <100 μm; and g. adding to the preparation from f), with agitation, sufficient sterile water for injection, U.S.P. to q.s. said suspension to 100 party by volume.