Patent US4310515A successfully refreshed from Google Patents.
US4310515A
Expired / Lapsed
US
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Pharmaceutical compositions of cisplatin
Assignee: Bristol Myers Co
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Filing: 1979-10-01
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Granted: 1982-01-12
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Expires: 1999-10-01
Abstract
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.
Inventors
- 👤 Edmund S. Granatek
- 👤 Gerald M. Ziemba
- 👤 Frederick L. Grab
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 11:23
CPC Classifications
A; A61; A61K; A61K33/00; A61K33/24; A61K33/243
Claims Analysis
Total Claims: 26
Claim 1
Independent Claim
60 words
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.
Claim 2
Dependent Claim
60 words
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.
Claim 3
Dependent Claim
60 words
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.
Claim 4
Dependent Claim
60 words
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.
Claim 5
Dependent Claim
56 words
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.
Claim 6
Dependent Claim
56 words
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.
Claim 7
Dependent Claim
57 words
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.
Claim 8
Dependent Claim
57 words
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.
Claim 9
Dependent Claim
57 words
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.
Claim 10
Dependent Claim
57 words
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.
Claim 11
Dependent Claim
53 words
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.
Claim 12
Dependent Claim
53 words
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.
Claim 13
Dependent Claim
109 words
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.
Claim 14
Dependent Claim
109 words
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.
Claim 15
Dependent Claim
117 words
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.
Claim 16
Dependent Claim
117 words
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.
Claim 17
Dependent Claim
124 words
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.
Claim 18
Dependent Claim
124 words
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.
Claim 19
Dependent Claim
121 words
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° C.
Claim 20
Dependent Claim
121 words
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° C.
Claim 21
Dependent Claim
87 words
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.
Claim 22
Dependent Claim
87 words
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.
Claim 23
Dependent Claim
96 words
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.
Claim 24
Dependent Claim
96 words
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.
Claim 25
Dependent Claim
108 words
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.
Claim 26
Dependent Claim
108 words
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.
References Cited (Backward Citations)
No citation records indexed.
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1985-01-11 | 1985-07-13 | 1986-01-12 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1989-01-11 | 1989-07-13 | 1990-01-12 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1993-01-11 | 1993-07-13 | 1994-01-12 | $7700.00 | Window Closed / Lapsed |