METHODS FOR BUFFERING MEDICAL SOLUTIONS

• US 20110282316A1
• Filed: 11/11/2010
• Published: 11/17/2011
• Est. Priority Date: 05/21/2008
• Status: Abandoned Application

• Current Assignee: Onpharma Inc. (Bausch Health Cos., Inc.)
• Original Assignee: Onpharma Inc. (Bausch Health Cos., Inc.)
• Inventors: Stepovich, Matthew J., Nguyen, Harry, Falkel, Michael I.
• Application Number:
  US12/944,492
• Publication Number:
  US 20110282316A1
• Time in Patent Office: Days
• US Class Current: 604/414
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2089 Containers or vials which are to be joined to each other in order to mix their contents combinations of vial and syringe for mixing their contents A61J1/2096
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 47/02 Inorganic compounds
• 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

Abstract

A device for delivering buffer solution into a buffer cartridge comprises a needle assembly and a pusher. The septa of a buffer cartridge and an anesthetic cartridge are advanced onto a transfer needle, and the pusher advances a plunger into the buffer cartridge to deliver buffer through the transfer needle into the anesthetic cartridge. A separate exhaust needle allows excess anesthetic from the anesthetic cartridge to be exhausted. A compression member is usually provided to maintain a force against the plunger on the buffer cartridge to pressurize and stabilize the contents during sterilization and/or storage. By delivering a buffer with a precisely controlled pH, accurate buffering of the anesthetic can be achieved.

Claims

1. A method for buffering the pH of a known volume of a medical solution in a container, said method comprising:

providing sodium bicarbonate buffer in a container, wherein the pH of the buffer is accurately known within ±

0.2 pH unit; and

combining a selected volume of the buffer from the container with the known volume of the medical solution in the container;

wherein the volume of buffer is selected based on the known volume of the medical solution and on the known pH of the buffer and a target pH of the buffered solution so that the actual pH of the buffered solution is with ±

0.2 pH unit of the target.

2. A method as in claim 1, wherein the medical solution comprises an anesthetic solution.

3. A method as in claim 1, wherein the medical solution is in a vial.

4. A method as in claim 1, wherein the medical solution is in a cartridge.

5. A method as in claim 1, wherein the buffer solution is in a vial.

6. A method as in claim 1, wherein the buffer solution is in a cartridge.

7. A method as in claim 1, wherein the combination of the solutions is accomplished by driving solution from the first container into the second container by placing the solution in the first container under a higher pressure than the second container, with a fluid exhaust path from the second container.

8. A method as in claim 2, wherein the anesthetic is selected from the group consisting of lidocaine, articaine, bupivacaine, and mepivicaine.

9. A method as in claim 8, wherein the medical solution further comprises epinephrine.

10. A method as in claim 1, wherein combining comprises penetrating a first end of a transfer needle through a septum in the buffer container and a second end of the transfer needle through a septum in the medical solution container and causing the selected volume of buffer to flow from the buffer container to the medical solution container.

11. A method as in claim 10, wherein combining further comprises penetrating an exhaust needle through the septum in the medical solution container and allowing excess medical solution to bleed from the medical solution container as the buffer enters the medical solution container.

12. A method as in claim 10, wherein the causing the selected volume of buffer to flow comprises advancing a plug in the buffer container to displace the selected volume of buffer from the buffer container.

13. A method as in claim 1, wherein the medical solution comprises lidocaine and wherein sodium bicarbonate buffer with a pH of 7.7±

0.3 is combined with the lidocaine at 1 ml buffer per 10 ml lidocaine to achieve a buffered pH of 7.2±

0.02.

14. A method as in claim 1, wherein the medical solution comprises lidocaine and wherein sodium bicarbonate buffer with a pH of 7.7±

0.15 is combined with the lidocaine at 1 ml buffer per 10 ml lidocaine to achieve a buffered pH of 7.2±

0.02.

15. A method as in claim 1, wherein the medical solution comprises lidocaine and wherein sodium bicarbonate buffer with a pH of 7.7±

0.10 is combined with the lidocaine at 1 ml buffer per 10 ml lidocaine to achieve a buffered pH of 7.2±

0.02.

16. A method as in claim 1, wherein the medical solution comprises local anesthetics other than lidocaine wherein sodium bicarbonate buffer with a pH of 7.7±

0.3 is combined with the other local anesthetic at 1 ml buffer per 10 ml local anesthetic to achieve a buffered pH of 7.2±

0.2.

17. A method as in claim 1, wherein the medical solution comprises a local anesthetic solution that includes epinephrine.

18. A method as in claim 1, wherein the medical solution comprises a local anesthetic solution that includes hyaluronidase.