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Claims for Patent: 4,310,515

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Claims for Patent: 4,310,515

Title: Pharmaceutical compositions of cisplatin
Abstract:A stable, sterile aqueous solution of cisplatin in a sealed container such as an ampul or vial in unit dosage form suitable for intravenous administration to man is provided which has a concentration of cisplatin between about 0.1 and about 1.0 mgm./ml. and a pH in the range of 2.0 to 3.0 or preferably about 2.5. It can also contain sodium chloride and mannitol.
Inventor(s): Granatek; Edmund S. (Syracuse, NY), Ziemba; Gerald M. (Bridgeport, NY), Grab; Frederick L. (Fayetteville, NY)
Assignee: Bristol-Myers Company (New York, NY)
Application Number:06/080,857
Patent Claims: 1. An injectable, stable, sterile aqueous solution of cisplatin in a unit dosage form in a sealed container, said solution being suitable for administration by the injection thereof into man upon the removal thereof from said container, said solution having a concentration of cisplatin between about 0.1 and about 1.0 mgm./ml. and a pH in the range of 2.0 to 3.0.

2. An injectable, stable, sterile aqueous solution of cisplatin in a unit dosage form in a sealed container, said solution being suitable for administration by the injection thereof into man upon the removal thereof from said container, said solution having a concentration of cisplatin between about 0.1 and about 1.0 mgm./ml. and a pH in the range of 2.3 to 2.7.

3. An injectable, stable, sterile aqueous solution of cisplatin in a unit dosage form in a sealed container, said solution being suitable for administration by the injection thereof into man upon the removal thereof from said container, said solution having a concentration of cisplatin between about 0.1 and about 1.0 mgm./ml. and a pH of about 2.5.

4. An injectable, stable, sterile aqueous solution of cisplatin in a unit dosage form in a sealed container, said solution being suitable for administration by the injection thereof into man upon the removal thereof from said container, said solution having a concentration of cisplatin of about 1.0 mgm./ml. and a pH in the range of 2.0 to 3.0.

5. An injectable, stable, sterile aqueous solution of cisplatin in a unit dosage form in a sealed container, said solution being suitable for administration by the injection thereof into man upon the removal thereof from said container, said solution having a concentration of cisplatin of about 1.0 mgm./ml. and a pH in the range of 2.3 to 2.7.

6. An injectable, stable, sterile aqueous solution of cisplatin in a unit dosage form in a sealed container, said solution being suitable for administration by the injection thereof into man upon the removal thereof from said container, said solution having a concentration of cisplatin of about 1.0 mgm./ml. and a pH of about 2.5.

7. An injectable, stable, sterile aqueous solution of cisplatin in a unit dosage form in a sealed container, said solution being suitable for administration by the injection thereof into man upon the removal thereof from said container, said solution having a concentration of cisplatin of about 1.0 mgm./ml. and a pH in the range of 2.3 to 2.7, said pH being caused by the presence of the appropriate amount of hydrochloric acid, said solution containing in addition a nontoxic, pharmaceutically acceptable, inorganic source of chloride ions in a concentration equivalent to that produced by the presence of sodium chloride in a concentration in the range of 1 to 20 mgm./ml.

8. An injectable, stable, sterile aqueous solution of cisplatin in a unit dosage form in a sealed container, said solution being suitable for administration by the injection thereof into man upon the removal thereof from said container, said solution having a concentration of cisplatin of about 1.0 mgm./ml. and a pH in the range of 2.3 to 2.7, said pH being caused by the presence of the appropriate amount of hydrochloric acid; said solution containing in addition a nontoxic, pharmaceutically acceptable, inorganic source of chloride ions in a concentration to that produced by the presence of sodium chloride in a concentration in the range of 1 to 20 mgm./ml.; said solution being free of any other added chemical.

9. An injectable, stable, sterile aqueous solution of cisplatin in a unit dosage form in a sealed container, said solution being suitable for administration by the injection thereof from said container, said solution having a concentration of cisplatin of about 1.0 mgm./ml. and a pH in the range of 2.3 to 2.7, said pH being caused by the presence of the appropriate amount of hydrochloric acid; said solution containing in addition a nontoxic, pharmaceutically acceptable, inorganic source of chloride ions in a concentration equivalent to that produced by the presence of sodium chloride in a concentration in the range of 1 to 20 mgm./ml.; said solution also containing a customary, harmless, physiologically acceptable excipient in a concentration in the range of 2 to 150 mgm./ml.

10. An injectable, stable, sterile aqueous solution of cisplatin in a unit dosage form in a sealed container, said solution being suitable for administration by the injection thereof into man upon the removal thereof from said container, said solution having a concentration of cisplatin of about 1.0 mgm./ml. and a pH in the range of 2.3 to 2.7, said pH being caused by the presence of the appropriate amount of hydrochloric acid; said solution containing in addition sodium chloride in a concentration of about 9 mgm./ml.; said solution also containing mannitol in a concentration of about 10 mgm./ml., said solution exhibiting less than 10% loss of potency as measured by high pressure liquid chromatography upon storage for one month at 56.degree. C.

11. An injectable, stable, sterile aqueous solution of cisplatin in a unit dosage form in a sealed container, said solution being suitable for administration by the injection thereof into man upon the removal thereof from said container, said solution having a concentration of cisplatin of about 1.0 mgm./ml. and a pH in the range of 2.3 to 2.7, said pH being caused by the presence of the appropriate amount of hydrochloric acid; said solution containing sodium chloride in a concentration in the range of 1 to 20 mgm./ml.

12. An injectable, stable, sterile aqueous solution of cisplatin in a unit dosage form in a sealed container, said solution being suitable for administration by the injection thereof into man upon the removal thereof from said container, said solution having a concentration of cisplatin of about 1.0 mgm./ml. and a pH in the range of 2.3 to 2.7, said pH being caused by the presence of the appropriate amount of hydrochloric acid; said solution containing sodium chloride in a concentration in the range of 1 to 20 mgm./ml.; said solution being free of any other added chemical.

13. An injectable, stable, sterile aqueous solution of cisplatin in a unit dosage form in a sealed container, said solution being suitable for administration by the injection thereof into man upon the removal thereof from said container, said solution having a concentration of cisplatin of about 1.0 mgm./ml. and a pH in the range of 2.3 to 2.7, said pH being caused by the presence of the appropriate amount of hydrochloric acid; said solution containing sodium chloride in a concentration in the range of 1 to 20 mgm./ml.; said solution also containing a customary, harmless, physiologically acceptable excipient in a concentration in the range of 2 to 150 mgm./ml.
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