Claims
- 1. A composition, comprising from 10 mg to 50 mg of Cis-platinum(II) diaminedichloride, from 45 mg to 450 mg of sodium chloride, from 100 mg to 1500 mg of mannitol, and from 0.01% to 0.05% of a non-toxic alcohol which is at least one member selected from the group consisting of ethyl alcohol, isopropyl alcohol and tert-butyl alcohol.
- 2. The composition of claim 1, said composition having a dissolution time of from 30 seconds to 1 minute in a pharmaceutically acceptable carrier, and a stability of at least two years when stored at room temperature.
- 3. The composition of claim 1, said composition comprising from 10 mg to 25 mg of Cis-platinum(II) diaminedichloride.
- 4. The composition of claim 1, said composition comprising from 25 mg to 50 mg of Cis-platinum(II) diaminedichloride.
- 5. A pharmacological composition, comprising a pharmaceutically effective amount of the composition of claim 1 in combination with a pharmaceutically acceptable carrier.
- 6. The pharmacological composition of claim 5, comprising from 10 mg to 25 mg of Cis-platinum(II) diaminedichloride.
- 7. The pharmacological composition of claim 5, comprising from 25 mg to 50 mg of Cis-platinum(II) diaminedichloride.
- 8. A process for producing the composition of claim 1, said process comprising:
- (i) preparing a solution containing from 10 mg to 50 mg of Cis-platinum(II) diaminedichloride, from 45 mg to 450 mg of sodium chloride, from 100 mg to 1500 mg of mannitol, and from 0.2% (v/v) to 5% (v/v) of a non-toxic alcohol which is at least one member selected from the group consisting of ethyl alcohol, isopropyl alcohol and tert-butyl alcohol;
- (ii) heating the said solution to a temperature of between 35.degree. C. and 45.degree. C., and adjusting the pH of the solution to a value of between 3.2 and 4; and
- (iii) freeze-drying the said solution.
- 9. A process for producing a Cis-platinumm (II) diaminedichloride composition, said process comprising:
- (i) freeze-drying a solution having a volume of from 5 ml to 37.5 ml, said solution comprising (a) from 10 mg to 50 mg of Cis-platinum(II) diaminedichloride, from 45 mg to 450 mg of sodium chloride, from 100 mg to 1500 mg of mannitol, from 0.2% (v/v) to 5% (v/v) of a non-toxic alcohol which is at least one member selected from the group consisting of ethyl alcohol, isopropyl alcohol, and tert-butyl alcohol, and water; and
- (ii) recovering the said Cis-platinum(II) diaminedichloride composition.
- 10. The process of claim 9, comprising using from 10 mg to 25 mg of Cis-platinum(II) diaminedichloride.
- 11. The process of claim 9, comprising using from 25 mg to 50 mg of Cis-platinum(II) diaminedichloride.
- 12. The process of claim 9, comprising adjusting the pH of the said solution, prior to freeze-drying, to a pH value of between 3.2 and 4.0.
- 13. The process of claim 12, comprising adjusting the said pH value with a dilute mineral acid.
- 14. The process of claim 12, comprising adjusting the said pH value with hydrochloric acid.
Priority Claims (1)
Number |
Date |
Country |
Kind |
23396 A/82 |
Sep 1982 |
ITX |
|
Parent Case Info
This is a continuation of application Ser. No. 532,382, filed Sept. 15, 1983, now abandoned.
US Referenced Citations (7)
Non-Patent Literature Citations (1)
Entry |
See-Lasley et al., "Manual of Oncology Therapeutics", The C. V. Masby Company, pp. 189-190 (1981). |
Continuations (1)
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Number |
Date |
Country |
Parent |
532382 |
Sep 1983 |
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