Device for conserving, extemporaneously preparing, and administering an active principle

• US 8,870,844 B2
• Filed: 04/17/2009
• Issued: 10/28/2014
• Est. Priority Date: 04/17/2008
• Status: Expired due to Fees

• Current Assignee: Philippe Perovitch, Tatiana Galperine
• Original Assignee: Philippe Perovitch, Tatiana Galperine
• Inventors: Perovitch, Philippe, Galperine, Tatiana
• Primary Examiner(s): Su, Susan
• Assistant Examiner(s): Townsend, Guy K
• Application Number:
  US12/937,748
• Publication Number:
  US 20110054437A1
• Time in Patent Office: 2,020 Days
• Field of Search: 604/411
• US Class Current: 604/411
• CPC Class Codes: A61J 1/065 Rigid ampoules, e.g. glass ampoules
• CPC Class Codes: A61J 1/2027 having frangible parts
• CPC Class Codes: A61J 1/2086 for fluid filtration
• CPC Class Codes: A61J 1/2093 Containers having several compartments for products to be mixed
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: B65D 51/2835 ruptured by a sharp element, e.g. a cutter or a piercer

Abstract

The invention provides a device (10) for conserving and extemporaneously preparing at least one active principle prior to administration, the device comprising: a body (12) that is constituted by at least one compartment for containing at least one volume of pharmaceutical solvent (22) that is less than 5 mL; a head (14) constituted by at least one compartment for containing at least one active principle (24), in particular a very small dose, and, in its top portion, by at least one dose-taking chamber (32) provided with a filter (40), the head (14) being capable of taking up a first position P1 for conservation, in which said head (14) is in its distal position relative to the body (12), and a second position P2 for preparation, in which said head (14) is in its proximal position relative to the body (12); at least one wall (16) separating the body (12) and the head (14); and rupture means (18) for rupturing said wall (16) so that the active principle (24) enters into contact with the solvent (22) and dissolves therein. The invention also seeks to use the device for conserving and extemporaneously preparing at least one active principle with a view to administering it.

Claims

1. A device for conserving and extemporaneously preparing a single injectable dose of at least one unstable active principle prior to administration, the device comprising:

a body made of thick plastic material or glass, said body comprising at least one compartment for containing at least one volume of pharmaceutical solvent that is less than 5 mL;

a head comprising at least one compartment for containing at least one active principle, and, in a top portion of the compartment, by at least one dose-taking chamber provided with a filter separating the compartment for containing the active principle from the dose-taking chamber, said head comprising a sterile perforatable membrane for protecting the dose, said device comprising a removable protective cap held on said head, the head being capable of taking up a first position P1 for conservation, in which said head is in its distal position relative to the body, and a second position P2 for preparation, in which said head is in its proximal position relative to the body;

at least one wall separating the body and the head; and

a perforator for rupturing said wall so that the active principle enters into contact with the solvent and dissolves therein.

2. A device according to claim 1, wherein the device includes a screw fastener for moving the head in translation, the a screw fastener comprising a screw thread that is carried by the body, and tapping of complementary profile to the screw thread of the container, and that is carried by the head in such a manner as to co-operate by screw-fastening.

3. A device according to claim 1, wherein the device includes a safety-locking ring so as to prevent any involuntary movement, in translation, of the head relative to the body.

4. A device according to claim 3, wherein the safety locking ring comprises a removable ring that is interposed between the head in its distal position and the body.

5. A device according to claim 1, wherein the perforator for rupturing the wall has a cutter configured to tear said wall when the head is in its proximal position.

6. A device according to claim 1, wherein said protective cap is held on the head by a safety tab.

7. A device according to claim 1, wherein the device includes a grip paddle that is disposed at the bottom portion of the body, so as to make a good two-digit pinch grip possible.

8. A device according to claim 1, wherein the device includes grip fins that are disposed in the top portion of the body.

9. A device according to claim 1, wherein the head includes grip fins on a peripheral outside surface.

10. A device according to claim 1, wherein the head includes at least two compartments for containing at least one of an active principle, an excipient, and a solvent, said compartments being separated by at least one wall, and at least one of the compartments containing an active principle.

11. A device according to claim 1, wherein the body includes at least two compartments for containing at least one of an active principle, an excipient and a solvent, said compartments being separated by at least one wall, and at least one of the compartments containing a solvent.

12. A device according to claim 11, wherein the body and the head and/or each compartment of the device are separated by at least one wall and by at least one additional membrane.

13. A device according to claim 1, wherein said active principle forms part of the family of beta-lactamides.

14. A method for conserving and extemporaneously preparing at least one active principle, comprising preparing the at least one active principle for an injectable dose with the device of claim 1.

15. A method of preparing at least an antibiotic active principle that forms part of the family of beta-lactamines, comprising preparing the at least one active antibiotic principle with the device of claim 14.

17. A method of preparing at least one active principle with the device of claim 1, wherein the at least one active principle is a liable active principle comprising at least one peptide or produced using biotechnology techniques.

18. A device according to claim 1, wherein the active principle is cefuroxime or cefazolin.

16. The method of chain 14, wherein the preparing of the at least one active principle comprises combining the at least one active principle with a anti-angiogenic active principle.

19. A device for conserving and extemporaneously preparing a single injectable dose of at least one unstable active principle prior to administration, the device comprising:

a body, the body having a compartment containing at least one volume of pharmaceutical solvent;

a head having a compartment containing at least one active principle and a dose-taking chamber provided with a filter between the compartment containing the active principle from the dose taking chamber, the head having a membrane that protects the dose and configured to be perforated by a needle carried by syringe while maintaining a seal around the needle;

a removable protective cap held on the head, the head configured to take up a first position P1 for conservation, in which the head is in a distal position relative to the body, and a second position P2 for preparation, in which the head is in a proximal position relative to the body;

at least one wall separating the body and the head; and

a perforator configured to rupture the wall so that the active principle enters into contact with the solvent and dissolves therein to thereby form the injectable dose of unstable active principle that is removable by the syringe and needle perforated through the membrane.

20. The device according to claim 19, comprising the active principle and the solvent that are configured to form the injectable dose of unstable active principle efficacious through injection;

and wherein the membrane is sterile.