Kit for Parenteral Administration of Medicaments

• US 20090264830A1
• Filed: 09/29/2006
• Published: 10/22/2009
• Est. Priority Date: 09/29/2005
• Status: Active Grant

• Current Assignee: INFA SA (Aluar Aluminio Argentino S.A.I. Y C.)
• Original Assignee: INFA SA (Aluar Aluminio Argentino S.A.I. Y C.)
• Inventors: Magri, Paolo, Villani, Flavio
• Granted Patent: US 8,182,449 B2
• Time in Patent Office: Days
• US Class Current: 604/191
• CPC Class Codes: A61K 31/337 having four-membered rings, e.g. taxol
• CPC Class Codes: A61K 31/436 the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
• CPC Class Codes: A61K 38/13 Cyclosporins
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61P 37/02 Immunomodulators

Abstract

The invention relates to a kit for parenteral administration of drugs, particularly a kit for the infusion of those medicaments dissolved in solvents that extract toxic components from PVC, which is also suitable for the infusion of highly active medicaments, said kit ensuring a safe administration both for the patient and for healthcare staff.

Claims

1. A kit for parenteral administration of drugs formulated in lipophilic solvents comprising:

a) at least one vessel containing a fluid for parenteral infusion;

b) at least one dosage unit comprising at least one drug formulated in a lipophilic solvent to be administered by the parenteral route;

c) at least one means for delivering the drug from the dosage unit (b) to the vessel (a);

the vessel (a), dosage unit (b) and means (c) being made of materials compatible with lipophilic solvents.

2. The kit according to claim 1, characterized in that said materials compatible with lipophilic solvents are other than conventional PVC.

3. The kit according to claim 1, characterized in that said materials compatible with lipophilic solvents are selected from glass, polyethylene, polypropylene and PVC free of any phthalates that may be released in lipophilic solvents.

4. The kit according to claim 1, characterized in that said vessel (a), dosage unit (b) and means (c) are made of either the same or different materials.

5. The kit according to claim 1, characterized in that said vessel (a) also comprises optional connectors, cannulae, flow regulators, filters and/or dosers.

6. The kit according to claim 1, characterized in that said dosage unit (b) is an ampoule, a vial or a bottle.

7. The kit according to claim 1, characterized in that the means (c) for delivering the drug is a syringe.

8. The kit according to claim 1, characterized in that it comprises two vessels (a).

9. The kit according to claim 1, characterized in that said fluid for parenteral infusion is selected from a saline and a glucose solution.

10. The kit according to claim 1, characterized in that said fluid for parenteral infusion is for intravenous infusion.

11. The kit according to claim 1, characterized in that said dosage unit (b) and said means (c) can be assembled to form a pre-filled syringe.

12. The kit according to claim 11, characterized in that it comprises:

a) at least one vessel containing a fluid for parenteral infusion;

b′

) at least one pre-filled syringe comprising at least one drug formulated in a lipophilic solvent to be administered by the parenteral route;

the vessel (a) and the pre-filled syringe (b′

) being made of materials compatible with lipophilic solvents.

13. The kit according to claim 1, characterized in that said drug is a highly active drug.

14. The kit according to claim 13, characterized in that said drug is selected from immunosuppressors, anti-tumoral agents and hormones.

15. The kit according to claim 14, characterized in that said drug is selected from tacrolimus, cyclosporine, taxanes, paclitaxel, docetaxel, alkylating agents, busulfan, carmustine, teniposide and valrubicin.

16. The kit according to claim 1, characterized in that said lipophilic solvents are selected from vegetable oils, polysorbates, polyethylene glycols, benzyl alcohol, ethanol and a mixture thereof.

17. The kit according claim 1, characterized in that it also comprises disposable gloves and an information leaflet.

18. The kit according to claim 11, comprising:

a) at least one vessel containing a fluid for intravenous infusion;

b′

) at least one pre-filled syringe comprising tacrolimus in a lipophilic medium.

19. The kit according to claim 18, comprising:

a) at least one vessel containing a solution for intravenous infusion that is selected from a saline and a glucose solution;

b′

) a pre-filled syringe comprising 1 ml of a 5 mg solution of anhydrous tacrolimus and 200 mg hydrogenated polyoxyethylenated castor oil (HCO-60) in dehydrated alcohol (USP 80% v/v).

20. The kit according to claim 18, characterized in that it comprises two vessels (a′

).

23. The kit according to claim 1, characterized in that said vessel (a) is a collapsible bottle or flask carrying a suitable rubber seal;

said dosage unit (b) is a vial also carrying a suitable rubber seal; and

said means (c) is a connector carrying one spike on each side.

24. The kit according to one of claim 23, characterized in that said the dosage unit (b) is a 5 to 10 ml vial containing 5 mg of anhydrous tacrolimus dissolved in 1 ml of lipophilic solvent.

25. The kit according to one of claim 24, characterized in that said 1 ml of lipophilic solvent is made of 200 mg hydrogenated polyoxyethylenated castor oil (HCO-60) and dehydrated alcohol (USP 80% v/v).

26. The kit according to claim 1, for the administration of drugs which need to be pre-diluted in a suitable solvent before they are delivered to

the infusion vessel (a), said kit further comprising:

a solvent containing vial for pre-dilution; and

means for carrying out said pre-dilution.

27. The kit according to claim 26, for the administration of drugs which need to be pre-diluted in a suitable solvent before they are delivered to the infusion vessel (a), said kit further comprising:

a solvent containing vial for pre-dilution;

a connector with spike on one side and luer lock on the other; and

a needle free syringe for the transfer of the solvent.

28. The kit according to claim 26, wherein said solvent containing vial for pre-dilution and said means for carrying out said pre-dilution are combined in a pre-filled syringe.

21. A kit for parenteral administration of PVC-incompatible drugs comprising:

a) at least one vessel containing a fluid for parenteral infusion;

b′

) at least one dosage unit comprising at least one PVC-incompatible drug to be administered by the parenteral route;

c) at least one means for delivering the drug from the dosage unit (b) to the vessel (a);

the vessel (a), the dosage unit (b′

″

) and the means (c) being made of materials other than PVC.

22. The kit according to claim 21, characterized in that said drug is a lipophilic drug, pentamidine or tacrolimus.