Systems and approaches for drug delivery device reconstitution

Patent metadata

Field	Value
Publication number	US-12370126-B2
Application number	US-202017763681-A
Country	US
Kind code	B2
Filing date	Oct 16, 2020
Priority date	Oct 18, 2019
Publication date	Jul 29, 2025
Grant date	Jul 29, 2025

Abstract

Drug reconstitution systems and related methods are disclosed herein. A drug reconstitution system may include a first component in a first container in a storage state and a second component in a second container in a storage state. The first component may be selected from a group of a drug product, a diluent, a saline solution, and an IV stabilizing solution (“IVSS”). The second component may be selected from a group of the drug product, the diluent, the saline solution, and the IVSS. The first component may be different than the second component. At least one fluid path may be configured to at least selectively fluidly connect the first container and the second container. An urging assembly may be configured to selectively urge at least a portion of the first component from the first container and into contact with the second component.

First claim

What is claimed is:

1. A drug reconstitution system comprising:
a first component selected from a group of a drug product, a diluent, a saline solution, and an IV stabilizing solution (“IVSS”), wherein the first component is in a first container in a storage state;
a second component selected from a group of the drug product, the diluent, the saline solution, and the IVSS, wherein the first component is different than the second component and the second component is in a second container in a storage state;
a third component selected from a group of the drug product, the diluent, the saline solution, and the IVSS, wherein the third component is different than the first component and the second component, wherein the third component is in a third container in a storage state;
a fourth component selected from a group of the drug product, the diluent, the saline solution, and the IVSS, wherein the fourth component is different than the first component, the second component, and the third component, wherein the fourth component is in a fourth container in a storage state;
at least one fluid path configured to at least selectively fluidly connect the first container and the second container;
an urging assembly configured to selectively urge at least a portion of the first component from the first container and into contact with the second component to mix the first component and the second component within a first portion of the at least one fluid path; and
at least one valve configured to selectively fluidly isolate the first portion of the at least one fluid path and a second portion of the at least one fluid path fluidly coupled with the third container and the fourth container.

2. The drug reconstitution system as in claim 1 , wherein the urging assembly includes at least one of the following: a pump at least selectively coupled with the at least one fluid path, at least one fluid path valve, at least one fluid path clamp, at least one fluid path closing component, at least one gravitational flow differential, a ramped surface, or a raised container support.

3. The drug reconstitution system as in claim 1 , wherein the first container, the second container, and third container are from a common kit packaging.

4. The drug reconstitution system as in claim 3 , wherein the first container, the second container, and the third container are packaged in the common kit packaging such that a sterile connection exists between the at least one fluid path and each of the first container, the second container, and the third container.

5. The drug reconstitution system as in claim 1 , wherein the first container, the second container, and the third container connect to the at least one fluid path at distinct locations such that the first container, the second container, and the third container are connected in series by the at least one fluid path.

6. The drug reconstitution system as in claim 1 , wherein the first container, the second container, third container, and the fourth container are from a common kit packaging.

7. The drug reconstitution system as in claim 6 , wherein the first container, the second container, the third container, and the fourth container are packaged in the common kit packaging such that a sterile connection exists between the at least one fluid path and each of the first container, the second container, the third container, and the fourth container.

8. The drug reconstitution system as in claim 1 , wherein the first container, the second container, the third container, and the fourth container connect to the at least one fluid path at distinct locations such that the first container, the second container, the third container, and the fourth container are connected in series by the at least one fluid path.

9. The drug reconstitution system as claim 1 , wherein the drug product is in the form of a bispecific T cell engager.

10. The drug reconstitution system as in claim 9 , wherein the bispecific T cell engager is a half-life extended (HLE) bispecific T cell engager.

11. A method of preparing a drug for delivery, the method comprising:
providing a diluent contained in a diluent container;
providing a drug product contained within a drug product container;
providing a saline solution contained in a saline container;
providing an IV stabilizing solution (“IVSS”) contained in an IVSS container;
providing a fluid path system physically connecting the diluent container, the drug product container, the saline container, and the IVSS container, the fluid path system having:
a storage configuration wherein the fluid path system is coupled with each of the diluent container, the drug product container, the saline container, and the IVSS container, the diluent container and the drug product container are not in fluid communication with each other, and the saline container and the IVSS container are not in fluid communication with each other,
a first mixing configuration wherein the diluent container and the drug product container are in fluid communication with each other via a first portion of the fluid path system, and
a second mixing configuration wherein the saline container and the IVSS container are in fluid communication with each other via a second portion of the fluid path system; and

adjusting the fluid path system from the storage configuration to the first mixing configuration to urge at least a portion of the diluent from the diluent container and/or at least a portion of the drug product from the drug product container to form a drug product/diluent mixture.

12. The method of claim 11 , wherein the step of adjusting the fluid path system from the storage configuration to the first mixing configuration includes opening a valve.

13. The method of claim 11 , wherein the step of adjusting the fluid path system from the storage configuration to the first mixing configuration includes removing a clamp.

14. The method of claim 11 , further comprising the steps of:
adjusting the fluid path system to the second mixing configuration to urge at least a portion of the saline solution from the saline container and/or at least a portion of the IVSS from the IVSS container to form a saline/IVSS mixture.

15. The method of claim 14 , further comprising the steps of:
adjusting the fluid path system from the storage configuration to a third mixing configuration to urge at least a portion of the drug product/diluent mixture and at least a portion of the saline/IVSS mixture into fluid communication with each other.

16. The method of claim 15 , further comprising the steps of:
providing a pump to be selectively coupled with the fluid path system; and
adjusting the position of the pump between a first position and a second position during at least two of the first, second, and third mixing configuration steps.

Assignees

• Amgen Inc

Inventors

• Mojarrad Mehran
• Gibson Scott R
• Li Xiaotong

Classifications

• A61M2209/06

  Packaging for specific medical equipment · CPC title

• A61M39/223

  Multiway valves · CPC title

• A61M39/16

  having provision for disinfection or sterilisation {(A61M39/143 takes precedence)} · CPC title

• A61J3/002

  Compounding apparatus specially for enteral or parenteral nutritive solutions (bottling liquids B67C) · CPC title

• A61J1/2089 Primary

  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 title