DEVICE TO DELIVER MAGNESIUM IN PEG FORMULATION

• US 20100249699A1
• Filed: 03/26/2009
• Published: 09/30/2010
• Est. Priority Date: 03/26/2009
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Marx, Jeffery C., Kimble, Toya D., ROY, Josee
• Granted Patent: US 9,078,808 B2
• Time in Patent Office: Days
• US Class Current: 604/84
• 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 comprising a hydrophilic compound and an active agent capable of bonding to the hydrophilic compound, the container comprising:

a first compartment storing either the hydrophilic compound or the active agent;

a second compartment fluidly isolated from the first compartment and storing the other of the hydrophilic compound or the active agent;

at least a frangible barrier shared between the first compartment and the second compartment; and

a fluidic outlet for dispensing from the container the medicinal formulation comprising at least the hydrophilic compound and the active agent,

wherein one of the first compartment or the second compartment comprises a first visually-detectable dye having a first color to provide visual evidence of mixing between the hydrophilic compound and the active agent.

2. The container of claim 1 wherein the first compartment, the second compartment, and the frangible barrier are formed within a shell, the frangible barrier separating the first compartment from the second compartment, and the fluidic outlet is engaged with the shell.

3. The container of claim 2 wherein the frangible barrier is a membrane.

5. The container of claim 1 wherein the compartment without the first dye comprises a second visually-detectable dye having a second color that is substantially visually different from the first color.

6. The container of claim 3 wherein the active agent comprises a magnesium salt (Mg) and the hydrophilic compound comprises polyethylene glycol (PEG).

7. The container of claim 5 wherein the medicinal formulation after mixing comprises 10 to 60% of PEG and 0.1 to 20% of magnesium salt by weight (g) of PEG or magnesium per 100 ml volume of the medicinal formulation.

8. 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 with an external connector comprising the at least a frangible barrier.

9. The container of claim 1 wherein the first compartment is defined by a first shell, and the second compartment is disposed within the first shell.

10. A method for administering a medicinal formulation dispensed from the device of claim 5, the method comprising:

rupturing the frangible barrier;

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

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

11. The method of claim 10 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.

12. The method of claim 11 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.

4. (canceled)