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Claims for Patent: 7,932,241

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Claims for Patent: 7,932,241

Title:Pharmaceutical products comprising bisphosphonates
Abstract: A pharmaceutical product comprises a container containing a bisphosphonate solution, in which at least the internal surface of the container comprises a plastic material and in which the container is heat sterilisable, and which is in the form of a ready to use infusion solution, for administration of the bisphosphonate to a patient in need of bisphosphonate treatment.
Inventor(s): Glausch; Alexandra (Weil am Rhein, DE), Loffler; Rolf (Freiburg, DE), Sigg; Juergen (Loerrach, DE)
Assignee: Novartis AG (Basel, CH)
Application Number:10/570,339
Patent Claims: 1. A pharmaceutical product comprising a) a heat sterilizable container having an internal surface that comprises a plastic material; and b) a ready to use solution disposed in the container, said solution comprising 2-(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid (zoledronic acid) or a pharmacologically acceptable salt thereof, wherein the product is in unit dose form having a volume of from about 20 ml up to about 500 ml.

2. The product according to claim 1, wherein the solution further comprises a buffering agent.

3. The product according to claim 2, wherein the buffering agent comprises an organic base and wherein the solution is adjusted with the organic base to a physiologically acceptable pH value of pH 5.5-8.0.

4. The product according to claim 3, wherein the organic base is sodium citrate.

5. The product according to claim 3, wherein the organic base is sodium acetate.

6. The product according to claim 2, wherein the buffering agent is sodium or potassium phosphate.

7. The product according to claim 2, wherein the buffering agent is sodium or potassium hydroxide.

8. The product according to claim 1, wherein the solution further comprises an isotonizing agent.

9. The product according to claim 8, wherein the isotonizing agent is a non-ionic isotonizing agent in which the solution is analyzable with a limit of quantitation for the concentration of the zoledronic acid or the pharmacologically acceptable salt thereof and byproducts and degradation products of the zoledronic acid or the pharmacologically acceptable salt thereof of at least 0.1% related to a declared dose.

10. The product according to claim 9, wherein the solution is analyzable by reversed phase chromatography with a complexation agent for determination of the concentration of the zoledronic acid or the pharmacologically acceptable salt thereof and byproducts and degradation products of the zoledronic acid or the pharmacologically acceptable salt thereof.

11. A pharmaceutical product comprising, a) a terminally heat sterilizable container having an internal surface that comprises a plastic material, and b) a ready to use solution disposed in the container, said solution comprising i. a unit dose of zoledronic acid or a pharmacologically acceptable salt thereof; ii. an organic base buffering agent, and iii. a non-ionic isotonizing agent.

12. The product according to claim 1, wherein the container is a prefillable plastic syringe.

13. The product according to claim 1, wherein the plastic material is transparent.

14. The product according to claim 1, wherein the plastic material is a cycloolefinic polymer.

15. The product according to claim 14, wherein the plastic material is a Daikyo CZ resin.

16. The product according to claim 1, wherein the container is an infusion bag.

17. The product according to claim 16, wherein the infusion bag is made of polypropylene or a polypropylene/Kraton blend, or wherein the infusion bag is a multilayer bag having polypropylene or polyethylene on the internal surface.

18. The product according to claim 1, wherein the container is made by the Blow/Fill/Seal technology, and further wherein the container is made of polyethylene or polypropylene.

19. The product according to claim 18, wherein the container is made of polypropylene.

20. The product according to claim 18, wherein the container is made of Rexene 32M2 polypropylene.

21. A process for the production of a ready to use pharmaceutical product comprising, a) filling a container having an internal surface with a solution comprising a zoledronic acid or a pharmacologically acceptable salt thereof, wherein the internal surface of the container comprises a transparent plastic material; and b) sterilizing the container.

22. The process according to claim 21, wherein step b) is achieved by terminal heat sterilization.

23. The process according to claim 22, wherein heat sterilization is at a temperature of at least about 110.degree. C. or higher.

24. The process according to claim 21, wherein step b) occurs from about 15 minutes up to about 3 hours.

25. The process according to claim 22, wherein heat sterilization is achieved by autoclaving conditions applied to obtain a sterility assurance level of at least 10.sup.-6.

26. The process according to claim 22, wherein heat sterilization is achieved by autoclaving conditions applied to obtain a sterility assurance level of at least 10.sup.-12.

27. The process according to claim 21, wherein the container is depyrogenised before filling with the solution.

28. The process according to claim 21, wherein the container is an endotoxin/pyrogen-free or a substantially endotoxin/pyrogen-free container.

29. The process according to claim 21, wherein the solution further comprises a non-ionic isotonizing agent and wherein the process further comprises the step of determining the concentration of the zoledronic acid or the pharmacologically acceptable salt thereof and byproducts and degradation products of the zoledronic acid or the pharmacologically acceptable salt thereof, wherein said determining step is achieved by ion chromatography, capillary electrophoresis, or high performance liquid chromatography (HPLC).

30. The process according to claim 19, wherein the solution further comprises a non-ionic isotonizing agent and wherein the process further comprises the step of determining the concentration of the zoledronic acid or the pharmacologically acceptable salt thereof and byproducts and degradation products of the zoledronic acid or the pharmacologically acceptable salt thereof, wherein said determining step is achieved by reversed phase chromatography with a complexation agent.
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