Method for mixing and dispensing a liquid pharmaceutical with a miscible component

• US 5,352,036 A
• Filed: 07/12/1993
• Issued: 10/04/1994
• Est. Priority Date: 09/23/1992
• Status: Expired due to Fees

• Current Assignee: Habley Medical Technology Corporation
• Original Assignee: Habley Medical Technology Corporation
• Inventors: Foster, Clark B., Smedley, William H., Haber, Terry M.
• Primary Examiner(s): Simone, Timothy F.
• Assistant Examiner(s): COOLEY, CHARLES E
• Application Number:
  US08/091,722
• Time in Patent Office: 449 Days
• Field of Search: 604/201, 604/228, 604/232, 604/416, 604/903, 604/51, 604/52, 604/56, 604/82, 206/219, 206/221, 206/818, 215/228, 215/231, 215/247, 215/DIG. 3, 215/DIG. 8, 366/129, 366/130, 366/273, 366/274, 366/342, 366/602, 366/347, 222/1, 222/226, 222/386, 128/898
• US Class Current: 366/130
• CPC Class Codes: A61J 1/065 Rigid ampoules, e.g. glass ampoules
• CPC Class Codes: A61J 1/2093 Containers having several compartments for products to be mixed
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 5/2448 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: B01F 31/441 performing a rectilinear reciprocating movement
• CPC Class Codes: B01F 33/452 using independent floating stirring elements
• CPC Class Codes: B65D 23/04 Means for mixing or for promoting flow of contents hydro-dynamic means for influencing the flow of liquids F15D
• CPC Class Codes: Y10S 206/818 Magnet
• CPC Class Codes: Y10S 215/08 Mixing
• CPC Class Codes: Y10S 604/903 Medical container with material agitation means

Abstract

A pharmaceutical mixing container for storing a liquid having at least two factions which tend to separate during storage. A housing has an inner volume and is closed at one end by a septum arrangement and at another end by a slidable sealing member. A magnetizable mixing member is located within the housing and contacts the liquid faction of the pharmaceutical contained within the housing. An external magnet produces a magnetic field which extends within the inner volume and interacts with the mixing element. By manually translating the magnet along the axis of the housing, the mixing member is forcibly moved through the liquid causing turbulent waves which provide thorough admixing for the pharmaceutical constituents. By controlling the pace of movement of the magnet, thorough admixing is provided without causing mechanical damage to delicate constituents, such as crystalline factions found in NPH type insulin.

Claims

1. A method of mixing and dispensing a liquid pharmaceutical having a liquid and a miscible component comprising the following steps:

providing a pharmaceutical container containing the liquid pharmaceutical with miscible component, the container having a first end, a second end and a wall structure defining an inner volume, the first end including a needle-pierceable member, the container including a magnetic mixing member within the inner volume;

positioning a magnetic field generating element external to the container;

moving the magnetic field generating element such that the magnetic mixing member is translated along the container to admix the miscible component within the liquid pharmaceutical;

controlling the relative velocity between the container and the magnetic field generating element such that the magnetic mixing member will create enough turbulence to thoroughly admix the miscible component within the liquid pharmaceutical without mechanically damaging the miscible component;

accessing the inner volume of the container through the needle-pierceable member by inserting the tip of a needle through the needle-pierceable member; and

withdrawing a volume of the now mixed liquid pharmaceutical with miscible component from the container through the needle.

2. The method of claim 1 wherein the providing step is carried out using an elastomeric septum as the needle-pierceable member.

3. The method of claim 2 wherein the providing step is carried out using a retaining band securing the elastomeric septum to the first end.

4. The method of claim 2 wherein the accessing step is carried out by inserting an end of a double ended syringe needle through the septum.

5. The method of claim 4 wherein the providing step includes the step of providing the container with a piston slidably housed within the container and wherein the withdrawing step is carried out by propelling a drive stem coupled to the piston such that said volume is urged out of the container through the double ended syringe needle.

6. The method of claim 2 wherein the accessing step is carried out by inserting the tip of a needle cannula of a syringe through the septum.

7. The method of claim 6 wherein the withdrawing step is carried out by drawing said volume into the syringe through the tip of the needle cannula.

8. The method of claim 1 wherein the providing step is carried out using a spherical magnetic mixing member.

9. The method of claim 1 wherein the providing step is carried out using a generally cylindrical glass pharmaceutical container.

10. The method of claim 1 wherein the positioning step is carried out by positioning an annular permanent magnet external to the container.

11. The method of claim 1 wherein the positioning step includes the step of selecting an annular permanent magnet having an inner surface that is geometrically conformable with an outer surface of the pharmaceutical container.

12. The method of claim 1 wherein the providing step is carried out using insulin as the liquid pharmaceutical with miscible component.

13. A method of mixing and dispensing liquid insulin, the insulin having a miscible component and a liquid component comprising the following steps:

providing a pharmaceutical container containing the liquid insulin, the container having a first end, a second end and a wall structure defining an inner volume, the first end including an elastomeric septum, the container including a magnetic mixing member within the inner volume and a piston slidably housed within said container;

positioning a magnetic field generating element external to the container;

moving the magnetic field generating element such that the magnetic mixing member is translated along the container to admix the miscible and liquid components of the liquid insulin;

controlling the relative velocity between the container and the magnetic field generating element such that the magnetic mixing member will create enough turbulence to thoroughly admix the miscible and liquid components of the liquid insulin without mechanically damaging the miscible component;

accessing the inner volume of the container through the elastomeric septum by inserting an end of a double ended syringe needle through the elastomeric septum; and

dispensing a volume of the now mixed liquid insulin from the container by forcing a drive stem against the piston such that said volume of the liquid insulin is urged out of the container through the double ended syringe needle.

14. A method of mixing and dispensing liquid insulin, the insulin having a miscible component and a liquid component comprising the following steps:

providing a pharmaceutical container containing the liquid insulin, the container having a first end, a second end and a wall structure defining an inner volume, the first end including an elastomeric septum, the container including a magnetic mixing member within the inner volume;

positioning a magnetic field generating element external to the container;

moving the magnetic field generating element such that the magnetic mixing member is translated along the container to admix the miscible and liquid components of the liquid insulin;

controlling the relative velocity between the container and the magnetic field generating element such that the magnetic mixing member will create enough turbulence to thoroughly admix the miscible and liquid components of the liquid insulin without mechanically damaging the miscible component;

accessing the inner volume of the container through the elastomeric septum by inserting the tip of a needle cannula of a syringe through the elastomeric septum; and

withdrawing a volume of the now mixed liquid insulin from the container by drawing said volume into the syringe through the tip of the needle cannula; and

dispensing at least a portion of the liquid insulin from the syringe.