Device to deliver magnesium in PEG formulation

• US 9,078,808 B2
• Filed: 03/26/2009
• Issued: 07/14/2015
• Est. Priority Date: 03/26/2009
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Roy, Josee, Kimble, Toya D., Marx, Jeffery C.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): LEE, WENG WAH
• Application Number:
  US12/411,537
• Publication Number:
  US 20100249699A1
• Time in Patent Office: 2,301 Days
• Field of Search: 604/84, 604/87, 604/86, 604/89, 604/92, 604/90, 604/416
• US Class Current: 1/1
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/2027 having frangible parts
• 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: A61J 1/2093 Containers having several compartments for products to be mixed
• CPC Class Codes: A61J 2205/20 Colour codes
• CPC Class Codes: A61K 33/06 Aluminium, calcium or magnesium; Compounds thereof , e.g. clay
• 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 container supplies a medicinal formulation that includes a hydrophilic polymer and an active agent capable of bonding to the polymer. The container includes a first compartment for storing the polymer and a second compartment fluidly isolated from the first compartment for storing the active agent. A frangible barrier is shared between the compartments. A fluidic outlet is disposed on the container to dispense the medicinal formulation. Dispensing of the medicinal formulation includes rupturing the frangible barrier, mixing the polymer and active agent together to form the medicinal formulation, and administering the medicinal formulation provided from the fluidic outlet to a patient. The polymer can be PEG, while the active agent can be magnesium.

Claims

1. A container to supply a medicinal formulation to a patient in need thereof, the container comprising:

a medicinal formulation comprising;

polyethylene glycol (PEG) comprising PEG3350 in an amount ranging from 10% to 60% by weight (g) per 100 ml volume of the medicinal formulation;

up to 80 mg of a magnesium chloride per kg of said patient'"'"'s weight, and the magnesium chloride is present in an amount ranging from 0.1 to 20% by weight (g) of magnesium per 100 ml volume of the medicinal formulation; and

an aqueous solution,

a first compartment storing either the PEG or the magnesium chloride of the medicinal formulation;

a second compartment disposed within the first compartment such that the second compartment is fluidly isolated from the first compartment, the second compartment storing the other of the PEG or the magnesium chloride of the medicinal formulation;

at least one first frangible barrier shared between the first compartment and the second compartment, wherein the first and second compartments each comprise an outer perimeter and the outer perimeter of the first compartment and the outer perimeter of the second compartment intersect one another such that the second compartment is disposed at the outer perimeter of the first compartment; and

a fluidic outlet for dispensing from the container the medicinal formulation, the fluidic outlet comprising at least one second frangible barrier disposed therein,

wherein rupturing said at least one first frangible barrier causes the content of said first and second compartments to mix producing said medicinal formulation such that said medicinal formulation is stable for up to 6 months before administration to said patient.

2. A method for administering a medicinal formulation dispensed from the device of claim 1, the method comprising:

rupturing the at least one first frangible barrier;

causing the PEG and magnesium chloride to become substantially uniformly mixed with each other; and

administering at least the resultant medicinal formulation provided from the fluidic outlet to a patient in need thereof.

3. The method of claim 2 wherein the medicinal formulation is administered to the patient at a dosage of about 0.5 to 10 ml/kg of the patient'"'"'s body weight.

4. The method of claim 3 wherein the dosage is administered to the patient at a rate such that the dosage is administered within one half-life of PEG within the patient.

5. The container of claim 1 wherein the first compartment, the second compartment, and the at least one first frangible barrier are formed within a shell, the at least one first frangible barrier separates the first compartment from the second compartment, and the fluidic outlet is engaged with the shell.

6. The container of claim 5 wherein the at least one first frangible barrier is a membrane.

7. The container of claim 1 wherein the first compartment comprises a first dye having a first color.

8. The container of claim 7 wherein the second compartment comprises a second dye having a second color that is substantially visually different from the first color.

9. The container of claim 1 wherein the first compartment is defined by a first shell, the second compartment is defined by a second shell, and the first and second shells are coupled to each other.

10. The container of claim 1 wherein the first compartment and the second compartment each have a substantially rectangular configuration.

11. The container of claim 1 wherein the first compartment is disposed within a shell, and the shell and the at least one first frangible barrier are made from the same material.

12. The container of claim 1 wherein the first compartment is disposed within a shell, the at least one first frangible barrier is made from a first material and the shell is made from a second material that is different from the first material, the first material being weaker than the second material.

13. The container of claim 1 wherein the at least one first frangible barrier is scored or etched to create regions of greater stress when under pressure.

14. The container of claim 1 wherein the first compartment comprises a center portion and the second compartment is offset from the center portion.

19. The container of claim 1, wherein the PEG is in an amount of 0.3 to 2.5 g per kg of said patient'"'"'s weight and the magnesium is in an amount of 8 to 65 mg per kg of said patient'"'"'s weight.

15. A container to supply a medicinal formulation to a patient in need thereof, the container comprising:

a medicinal formulation comprising;

polyethylene glycol (PEG) comprising PEG3350 in an amount ranging from 10% to 60% by weight (g) per 100 ml volume of the medicinal formulation;

up to 80 mg of a magnesium chloride per kg of said patient'"'"'s weight, and the magnesium chloride is present in an amount ranging from 0.1 to 20% by weight (g) of magnesium per 100 ml volume of the medicinal formulation; and

an aqueous solution,

a first compartment storing either the PEG or the magnesium chloride of the medicinal formulation;

a second compartment spaced apart from the first compartment, the second compartment storing the other of the PEG or the magnesium chloride of the medicinal formulation;

a connector linking the first compartment and the second compartment, the connector comprising at least one first frangible barrier to fluidly separate the first and second compartments; and

a fluidic outlet for dispensing from the container the medicinal formulation, the fluidic outlet comprising at least one second frangible barrier disposed therein,

wherein rupturing said at least one first frangible barrier causes the content of said first and second compartments to mix producing said medicinal formulation such that said medicinal formulation is stable for up to 6 months before administration to said patient.

16. A method for administering a medicinal formulation dispensed from the device of claim 15, the method comprising:

rupturing the at least one first frangible barrier;

causing the PEG and magnesium chloride to become substantially uniformly mixed with each other; and

administering at least the resultant medicinal formulation provided from the fluidic outlet to a patient in need thereof.

17. The container of claim 15 wherein the at least one first frangible barrier is a single frangible barrier positioned in a middle portion of the connector.

18. The container of claim 15 wherein the at least one first frangible barrier comprises one frangible barrier in a first end of the connector in communication with the first compartment and another frangible barrier positioned within a second end of the connector opposite the first end in communication with the second compartment.

20. The container of claim 15, wherein the PEG is in an amount of 0.3 to 2.5 g per kg of said patient'"'"'s weight and the magnesium is in an amount of 8 to 65 mg per kg of said patient'"'"'s weight.