CN-122028944-A - Sequential injection syringe

Abstract

A sequential injection syringe is provided having a barrel with a proximal end, a distal end, and a sidewall with an opening, the sidewall defining a syringe interior therebetween, a plunger rod at least partially received within the syringe interior and slidable relative to the barrel, the plunger rod having a proximal end and a distal end, a plunger stopper disposed at the distal end of the plunger rod, a valve stopper disposed in the syringe interior and configured to divide the syringe interior into a first chamber and a second chamber, a concentrated pharmaceutical composition received within the second chamber, and a diluent received within the first chamber.

Inventors

• Guillaume Ley
• Claire Brune

Assignees

• 贝克顿迪金森法国公司

Dates

Publication Date

20260512

Application Date

20241014

Priority Date

20231016

Claims (19)

1. 1. A sequential injection syringe comprising: a barrel including a proximal end, a distal end having an opening, and a sidewall defining a syringe interior between the proximal end and the distal end; a plunger rod received at least partially within the syringe interior and slidable relative to the barrel, the plunger rod having a proximal end and a distal end; a plunger stop disposed at the distal end of the plunger rod; A valve stopper disposed in the syringe interior and configured to divide the syringe interior into a first chamber and a second chamber; a concentrated pharmaceutical composition received within at least one of the first chamber and the second chamber, and A diluent received within at least one of the first chamber and the second chamber, wherein the concentration of the pharmaceutical composition received within the second chamber is at least 10 μg/ml and the pharmaceutical composition comprises mRNA.
2. 2. The sequential injection syringe of claim 1, wherein the concentrated pharmaceutical composition is received within the second chamber and the diluent is received within the first chamber.
3. 3. The sequential injection syringe of claim 1, wherein the concentrated pharmaceutical composition is received within the first chamber and the diluent is received within the second chamber.
4. 4. A sequential injection syringe according to any one of claims 1 to 3, wherein the concentration of the pharmaceutical composition received in the second chamber is at least 100 μg/ml.
5. 5. The sequential injection syringe of any one of claims 1-4, wherein the diluent is water for injection or a buffer.
6. 6. The sequential injection syringe of any one of claims 1-5, wherein the barrel comprises glass or plastic.
7. 7. A sequential injection syringe according to any one of claims 1 to 6, wherein the inner surface of the barrel is coated with a friction reducing composition.
8. 8. The sequential injection syringe of any one of claims 1-7, wherein the valve stopper and/or the plunger stopper comprise an elastomeric material.
9. 9. Sequential injection syringe according to any of claims 1 to 8, wherein the valve stopper and/or the plunger stopper are coated with a friction reducing material.
10. 10. Sequential injection syringe according to any of claims 1 to 9, wherein the valve stopper is configured to co-extensive move simultaneously with the plunger rod such that the ratio of the volume of the first chamber to the volume of the second chamber remains substantially constant during the initial phase of plunger rod movement.
11. 11. The sequential injection syringe of any one of claims 1-10, wherein the valve stopper is configured such that during an initial phase of plunger rod movement, the second chamber is not in fluid communication with the first chamber.
12. 12. The sequential injection syringe of any one of claims 1 to 11, wherein as the plunger rod reaches its distal-most position, the hydrostatic pressure within the syringe is unbalanced such that the second chamber is in fluid communication with the first chamber.
13. 13. The sequential injection syringe of any one of claims 1-12, wherein the valve stopper includes one or more reversibly sealed openings therethrough.
14. 14. The sequential injection syringe of any one of claims 1 to 13, wherein the second chamber is in fluid communication with the first chamber such that a dead volume of the first chamber is flushed through an opening.
15. 15. The sequential injection syringe of any one of claims 1-14, wherein dead volume is between about 2.5 μl to about 70 μl.
16. 16. A kit comprising one or more sequential injection syringes according to any one of claims 1 to 15.
17. 17. A sequential injection syringe comprising: a barrel including a proximal end, a distal end having an opening, and a sidewall defining a syringe interior between the proximal end and the distal end; a plunger rod received at least partially within the syringe interior and slidable relative to the barrel, the plunger rod having a proximal end and a distal end; a plunger stop disposed at the distal end of the plunger rod; A valve stopper disposed in the syringe interior and configured to divide the syringe interior into a first chamber and a second chamber; a concentrated pharmaceutical composition received within at least one of the first chamber and the second chamber, and A second pharmaceutical composition received within at least the other of the first chamber and the second chamber, the second pharmaceutical composition being different from the concentrated pharmaceutical composition, wherein the concentration of the pharmaceutical composition is at least 10 μg/ml and the pharmaceutical composition comprises mRNA.
18. 18. The sequential injection syringe of claim 17, wherein the concentrated pharmaceutical composition is received within the second chamber and the second pharmaceutical composition is received within the first chamber.
19. 19. The sequential injection syringe of claim 17, wherein the concentrated pharmaceutical composition is received within the first chamber and the second pharmaceutical composition is received within the second chamber.

Description

Sequential injection syringe Cross Reference to Related Applications The present application claims priority from European patent application Ser. No. 23306804.8, entitled "Sequential-Injection Syringe," filed on 10/16 of 2023, the entire disclosure of which is incorporated herein by reference. Background Technical Field Provided herein are sequential injection syringes for delivering compositions. Description of the Related Art Many therapeutic compositions exhibit increased stability when the active pharmaceutical ingredient (active pharmaceutical ingredient, API) is present in the therapeutic composition at higher levels of concentration. However, increasing the concentration of the API results in a decrease in the volume of the therapeutic composition, and therefore, any dead volume within the container holding the therapeutic composition becomes a greater issue. Thus, there is a need in the art for a drug delivery device that effectively handles dead volumes and allows for the delivery of full doses of therapeutic composition to a patient. Summary of the invention A sequential injection syringe is provided having a barrel with a proximal end, a distal end, and a sidewall with an opening, the sidewall defining a syringe interior therebetween, a plunger rod at least partially received within the syringe interior and slidable relative to the barrel, the plunger rod having a proximal end and a distal end, a plunger stopper disposed at the distal end of the plunger rod, a valve stopper disposed within the syringe interior and configured to divide the syringe interior into a first chamber and a second chamber, a concentrated pharmaceutical composition received within at least one of the first chamber and the second chamber, and a diluent received within at least the other of the first chamber and the second chamber. Further non-limiting embodiments are set forth in the following numbered items: The sequential injection syringe of clause 1, comprising a barrel including a proximal end, a distal end, and a sidewall having an opening, the sidewall defining a syringe interior between the proximal end and the distal end, a plunger rod at least partially received within the syringe interior and slidable relative to the barrel, the plunger rod having a proximal end and a distal end, a plunger stopper disposed at the distal end of the plunger rod, a valve stopper disposed in the syringe interior and configured to partially divide the syringe interior into a first chamber and a second chamber, a concentrated pharmaceutical composition received within at least one of the first chamber and the second chamber, and a diluent received within at least the other of the first chamber and the second chamber. The sequential injection syringe according to clause 1, wherein the concentrated pharmaceutical composition is received in the second chamber and the diluent is received in the first chamber. The sequential injection syringe according to clause 1, wherein the concentrated pharmaceutical composition is received in the first chamber and the diluent is received in the second chamber. The sequential injection syringe according to any one of clauses 1 to 3, wherein the concentration of the pharmaceutical composition received in the second chamber is at least 10 μg/ml, alternatively at least 100 μg/ml. The sequential injection syringe according to any one of items 1 to 4, wherein the pharmaceutical composition comprises mRNA. The sequential injection syringe according to any one of items 1 to 5, wherein the diluent is water for injection or a buffer. Item 7 the sequential injection syringe according to any one of items 1 to 6, wherein the barrel comprises glass or plastic. Item 8 the sequential injection syringe according to any one of items 1 to 7, wherein the inner surface of the barrel is coated with a friction reducing composition. Item 9 the sequential injection syringe according to any of items 1 to 8, wherein the valve stopper and/or the plunger stopper comprises an elastomeric material. Item 10 the sequential injection syringe according to any of items 1 to 9, wherein the valve stopper and/or the plunger stopper is coated with a friction reducing material. Item 11 the sequential injection syringe of any one of items 1 to 10, wherein the valve stopper is configured to move co-extensionally (co-extensively) with the plunger rod simultaneously such that the ratio of the volume of the first chamber to the volume of the second chamber remains substantially constant during an initial phase of plunger rod movement. The sequential injection syringe of any one of clauses 1-11, wherein the valve stopper is configured such that the second chamber is not in fluid communication with the first chamber during the initial phase of plunger rod movement. Item 13 the sequential injection syringe of any one of items 1 to 12, wherein as the plunger rod reaches its distal-most position, the hydrostatic pressure within the syringe is imbalanc