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Last Updated: April 23, 2024

Claims for Patent: 5,310,727


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Summary for Patent: 5,310,727
Title: Pharmaceutical compositions for parenteral use containing a calcitonin as the active ingredient
Abstract:A freeze-dried pharmaceutical composition for parenteral administration which includes a therapeutically effective amount of a calcitonin, as the active ingredient, and human albumin. The injectable solution which is obtained by dissolving the freeze-dried composition in a physiologically acceptable solvent is also described.
Inventor(s): Lattanzi; Filippo (Siena, IT), Vanni; Riccardo (Siena, IT)
Assignee: Scalvo S.p.A. (Siena, IT)
Application Number:07/620,399
Patent Claims:1. A lyophilized pharmaceutical composition comprising calcitonin and from 0.005 to 2.5 mg of human albumin per IU of calcitonin.

2. The composition of claim 1 wherein the amount of human albumin is between 0.05 and 2 mg per IU of calcitonin.

3. The composition of claim 2 wherein the amount of human albumin is between 0.1 and 1.2 mg per IU of calcitonin.

4. The composition of claim 1 wherein calcitonin is salmon calcitonin or eel calcitonin.

5. The composition of claim 4 wherein calcitonin is eel calcitonin.

6. The composition of claim 1 which further comprises a pharmaceutically acceptable acid, acid salt or acid buffer in a concentration sufficient to impart a pH of from 3.5 and 5.5 to the composition.

7. The composition of claim 6 wherein the concentration of said acid, acid salt or acid buffer is sufficient to impart a pH of from 4.0 and 5.0 to the composition.

8. The composition of claim 7 wherein the concentration of said acid, acid salt or acid buffer is sufficient to impart a pH of from 4.4 and 4.8 to the composition.

9. The composition of claim 6 wherein said acid salt is monobasic sodium phosphate.

10. The composition of claim 1 containing from 1 to 250 IU of calcitonin.

11. A single-dose administration unit consisting of the composition of claim 10 and from 1 to 5 ml of a physiologically acceptable solvent.

12. The single-dose administration unit of claim 11 wherein the amount of calcitonin is between 10 and 200 IU.

13. The single-dose administration unit of claim 11 wherein the physiologically acceptable solvent is sterile water.

14. A lyophilized pharmaceutical composition which comprises eel calcitonin and from 0.1 to 1.2 mg of human albumin.

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