Delivery of Two or More Medicaments Through a Single Dose Selection and Dispense Interface

• US 20120136334A1
• Filed: 06/01/2010
• Published: 05/31/2012
• Est. Priority Date: 06/02/2009
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Boyd, Malcolm Stanley, Leak, David Martin, Sanders, David, Marshall, Elizabeth Anne, Smith, Christopher James, De Sausmarez Lintell, Daneil Thomas, Keating, Carmen Patricia, Graham, Jay, MacArthur, Ross Douglas Laurie, Heald, Michael James, Ortiz, Elliot Lucas
• Granted Patent: US 9,592,342 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61M 11/007 Syringe-type or piston-type sprayers or atomisers
• CPC Class Codes: A61M 15/0035 Piercing means
• CPC Class Codes: A61M 2005/1787 Syringes for sequential delivery of fluids, e.g. first medicament and then flushing liquid
• CPC Class Codes: A61M 2005/3142 Modular constructions, e.g. supplied in separate pieces to be assembled by end-user
• CPC Class Codes: A61M 5/2448 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/2455 with sealing means to be broken or opened
• CPC Class Codes: A61M 5/31551 including axial movement of dose setting member
• CPC Class Codes: A61M 5/31561 using freely adjustable volume steps
• CPC Class Codes: A61M 5/3294 comprising means for injection of two or more media, e.g. by mixing

Abstract

An injection system for co-delivery of two medicaments (1, 2) having a drug delivery device (7) containing a primary reservoir (11) containing a first medicament (1) and having a secondary reservoir (5, 17, 30) containing a second medicament (2) where the drug delivery device (7) has only one dose setter (12) for the primary reservoir (11) and that automatically determines the dose of the second medicament (2). Both medicaments (1, 2) are delivered through a single dispense interface (3, 16, 21, 31).

Claims

1. A drug delivery system to deliver two or more medicaments operable through a single dispense interface, comprising,

a. a primary reservoir (11) of medicament (1) containing at least one drug agent;

b. a dose button (13) operably connected to the primary reservoir (11) of medicament (1);

c. a single dispense interface (3, 16, 21, 31) configured for fluid communication with the primary reservoir (11); and

d. a secondary reservoir (5, 17, 30) of medicament (2) containing at least one drug agent configured for fluid communication to the single dispense interface (3, 16, 21, 31);

wherein a single activation of the dose button (13) causes medicament (1) from the primary reservoir (11) and a non-user settable dose of the second medicament (2) to be expelled through the single dispense interface (3, 16, 21, 31).

2. The system of claim 1 comprising a housing containing a single dose setter (12) operably connected to the primary reservoir (11) of medicament (1).

3. The system of any of claim 1 or 2 where a single operation of the dose button (13) causes medicament (1) from the primary reservoir (11) to be expelled through the single dispense interface (3, 16, 21, 31) after a therapeutic dose of the non-user settable dose of medicament (2) has been expelled through the single dispense interface (3, 16, 21, 31).

4. The system of any of claims 1 to 3 where at least one of the secondary reservoir (5, 17, 30) of medicament (2) and the primary reservoir (11) of medicament (1) contains a single dose.

5. The system of any of claims 1 to 4 where at least one of the primary reservoir (11) and the secondary reservoir (5, 17, 30) contains a liquid medicament (1, 2).

6. The system of any of claims 1 to 5 where at least one of the primary reservoir (11) and the secondary reservoir (5, 17, 30) comprises at least one pierceable seal (10, 32a, 32b).

7. The system of any of claims 1 to 6 where at least one of the primary reservoir (11) and the secondary reservoir (5, 17, 30) contains multiple doses of medicament (1, 2).

8. The system of any of claims 1 to 7 where the single dispense interface (3, 16, 21, 31) is a hollow needle (3, 16, 21, 31).

9. The system of any of claims 1 to 8 where the secondary reservoir (5, 30) and the single dispense interface (3, 16, 21, 31) are contained in a single module (4) that is disposable and replaceable with a replacement module (4) containing a new secondary reservoir (5, 17, 30) of medicament and a new single dispense interface (3, 16, 21, 31).

10. The system of claim 9 where the single module (4) contains a safety shield.

11. The system of any of claims 1 to 10 where at least one of the primary reservoir (11) and the secondary reservoir (5, 17, 30) is replaceable.

12. The system of any of claims 1 to 11 where at least one of the primary reservoir (11) and the secondary reservoir (5, 17, 30) is in fluid communication with the single dispense interface (3, 16, 21, 31).

13. A method of dispensing at least two medicaments from separate reservoirs, comprising, in combination, the steps of

a. providing a drug device (7) comprising,

i. a primary reservoir (11) of medicament (1) containing at least one drug agent;

ii. a dose button (13) operably connected to the primary reservoir (11) of medicament (1); and

iii. a single dispense interface (3, 16, 21, 31) configured for fluid communication with the primary reservoir (11);

b. providing a secondary reservoir (5, 17, 30) of medicament (2) containing at least one drug agent configured for fluid communication to the single dispense interface (3, 16, 21, 31),

wherein a single activation of the dose button (13) causes medicament (1) from the primary reservoir (11) and a non-user settable dose of medicament (2) from the secondary reservoir (5, 17, 30) to be expelled through the single dispense interface (3, 16, 21, 31).

15. The method of any of claim 13 or 14 wherein the second medicament (2) is expelled through the single dispense interface (3, 16, 21, 31) simultaneously with the flow of the first medicament (1).

16. The method of any of claims 13 to 15 wherein the first medicament (1) is expelled through the drug dispense interface (3, 16, 21, 31) after expulsion of a therapeutic dose of the non-user settable dose of the second medicament (2) through the single dispense interface (3, 16, 21, 31).

17. The method of any of claims 13 to 16, wherein the set dose of the first medicament (1) cannot be less than the non-user settable dose of the second medicament (2).

18. The method of any of claims 13 to 17 wherein at least 80% of the second medicament (2) is expelled through the single dispense interface (3, 16, 21, 31).

14. A method of dispensing a non-user settable dose of one medicament and a dose of a primary medicament from separate reservoirs, comprising, in combination, the steps of

a. setting a dose of a first medicament (1) contained in a primary reservoir (11) using a single dose setter (12) of a drug delivery device (7);

b. automatically setting a non-user settable dose of a second medicament (2) contained in a secondary reservoir (5, 17, 30) based on the set dose of the first medicament (1);

c. moving the set dose of the first medicament (1) from the primary reservoir (11) causing it to flow in a distal direction; and

d. forcing the set dose of the first medicament (1) and the non-user settable dose of the second medicament (2) through a single dispense interface (3, 16, 21, 31).