Pharmaceutical compositions

Sterile, stable, microcrystalline cisplatin in a sealed container in unit dosage form, reconstitutable with sterile water within about three minutes at a concentration of 1 mg. of microcrystalline cisplatin per ml. of sterile water, and suitable for intravenous administration to man;

• said microcrystalline cisplatin having a particle size distribution of at least about 80% in the range of 0 to 5 micrometers, less than about 20% in the range of 5 to 20 micrometers and essentially no particles larger than 20 micrometers;
• the crystalline form of said microcrystalline cisplatin being different from that of lyophilized cisplatin as demonstrable by x-ray powder diffraction patterns.

A sterile, stable, dry-mix of microcrystalline cisplatin in a sealed container in unit dosage form, reconstitutable with sterile water within about three minutes at a concentration of 1 mg. of microcrystalline cisplatin per ml. of sterile water, and suitable for intravenous administration to man;

• said dry-mix also containing a sterile, nontoxic, pharmaceutically acceptable, inorganic source of chloride ions in an amount equivalent to that produced by the presence of sodium chloride in a concentration of from about 1 to about 20 mgs. per mg. of microcrystalline cisplatin;
• said microcrystalline cisplatin having a particle size distribution of at least about 80% in the range of 0 to 5 micrometers, less than about 20% in the range of 5 to 20 micrometers and essentially no particles larger than 20 micrometers;
• the crystalline form of said microcrystalline cisplatin being different from that of lyophilized cisplatin as demonstrable by x-ray powder diffraction patterns.

A sterile, stable, dry-mix of microcrystalline cisplatin in a sealed container in unit dosage form, reconstitutable with sterile water within about three minutes at a concentration of 1 mg. of microcrystalline cisplatin per ml. of sterile water, and suitable for intravenous administration to man;

• said dry-mix also containing a customary, harmless, physiologically acceptable excipient in a concentration of from about 2 mgs. to about 150 mgs. per mg. of microcrystalline cisplatin;
• said microcrystalline cisplatin having a particle size distribution of at least about 80% in the range of 0 to 5 micrometers, less than about 20% in the range of 5 to 20 micrometers and essentially no particles larger than 20 micrometers;
• the crystalline form of said microcrystalline cisplatin being different from that of lyophilized cisplatin as demonstrable by x-ray powder diffraction patterns.

A sterile, stable dry-mix of microcrystalline cisplatin in a sealed container in unit dosage form, reconstitutable with sterile water within about three minutes at a concentration of 1 mg. of microcrystalline cisplatin per ml. of sterile water, and suitable for intravenous administration to man;

• said dry-mix also containing both a sterile, nontoxic, pharmaceutically acceptable, inorganic source of chloride ions in an amount equivalent to that produced by the presence of sodium chloride in a concentration of from about 1 to about 20 mgs. per mg. of microcrystalline cisplatin and a customary, harmless, physiologically acceptable excipient in a concentration of from about 2 mgs. to about 150 mgs. per mg. of microcrystalline cisplatin;
• said microcrystalline cisplatin having a particle size distribution of at least about 80% in the range of 0 to 5 micrometers, less than about 20% in the range of 5 to 20 micrometers and essentially no particles larger than 20 micrometers;
• the crystalline form of said microcrystalline cisplatin being different from that of lyophilized cisplatin as demonstrable by x-ray powder diffraction patterns.