Pre-filled syringe

Patent metadata

Field	Value
Publication number	US-10835503-B2
Application number	US-201715405877-A
Country	US
Kind code	B2
Filing date	Jan 13, 2017
Priority date	Jan 13, 2017
Publication date	Nov 17, 2020
Grant date	Nov 17, 2020

Abstract

The invention relates to a pre-filled syringe, an auto-injector device comprising such pre-filled syringe, a method of administering a pharmaceutical composition with such auto-injector device, and a manufacturing method for such auto-injector device. The pre-filled syringe comprises a container and a needle. The container is filled with a pharmaceutical composition comprising epinephrine, a buffer, and water. The buffer is configured to buffer in a pH range between 3 and 4. The needle is adhered to the container by means of a urethane acrylate or urethane methacrylate acrylic light cure adhesive, which is configured to provide a pull out resistance of the needle relative to the container which is between 30 N to 100 N, preferably between 50 N to 70 N, more preferably greater than 60 N after 90 days exposure to the pharmaceutical composition at 40° C. and 75% relative humidity (RH). In an example, the pharmaceutical composition is for the treatment of an anaphylactic event.

First claim

The invention claimed is:

1. An auto-injector device comprising:
a pre-filled syringe, and
a firing mechanism,
wherein the pre-filled syringe comprises a stainless steel needle and a glass container,
wherein the container is filled with a pharmaceutical composition comprising epinephrine, a buffer, and water,
wherein the pre-filled syringe provides about 1 mL of the pharmaceutical composition,
wherein the buffer is configured to buffer in a pH range between 3 and 4,
wherein the needle is made from high corrosion resistance steel and is adhered to the container by means of a urethane acrylate or urethane methacrylate acrylic light cure adhesive,
wherein the urethane acrylate or urethane methacrylate acrylic light cure adhesive is configured to provide a pull out resistance of the needle relative to the container which is between 30 N to 100 N, preferably between 50 N to 70 N, more preferably greater than 60 N after 90 days exposure to the pharmaceutical composition at 40° C. and 75% RH,
wherein the firing mechanism is configured to expel the pharmaceutical composition from the pre-filled syringe and to inject it into a subject, and
wherein the auto-injector device is configured to deliver about 0.3 ml of the pharmaceutical composition during a single injection in below 0.5 sec.

2. The auto-injector device according to claim 1 , wherein the high corrosion resistance steel comprises 15 to 20% Cr, 8 to 16% Ni and 1 to 4% Mo.

3. The auto-injector device according to claim 1 , wherein the high corrosion resistance steel comprises 15 to 25% Cr, 20 to 30% Ni and 3 to 6% Mo.

4. The auto-injector device according to claim 1 , wherein the needle has an inner diameter (ID) between 0.39 to 0.53 mm.

5. The auto-injector device according to claim 1 , wherein the buffer is a bicarboxylic acid.

6. The auto-injector device according to claim 1 , wherein the buffer is a tartrate salt.

7. The auto-injector device according to claim 1 , wherein the buffer is sodium tartrate dihydrate.

8. The auto-injector device according to claim 7 , wherein the sodium tartrate dihydrate content is between 1.0 and 1.6 mg/mL for adult patients or between 0.5 and 0.8 mg/mL for pediatric patients.

9. The auto-injector device of claim 7 , wherein the sodium tartrate dihydrate content is about 1.38 mg/mL for adult patients or about 0.69 mg/mL for pediatric patients.

10. The auto-injector device according to claim 1 , wherein the pharmaceutical composition further comprises an antioxidant,
wherein the antioxidant is sodium metabisulfite, and
wherein the sodium metabisulfite content in the pharmaceutical composition is about 1.2 mg/mL.

11. The auto-injector device according to claim 1 , wherein the pharmaceutical composition further comprises a pH adjuster and a tonicity adjuster,
wherein the pH adjuster is a hydrochloric acid,
wherein the tonicity adjuster is a sodium chloride, and
wherein the epinephrine content is between 0.9 and 1.1 mg/mL for adult patients or between 0.4 and 0.6 mg/mL for pediatric patients.

12. The auto-injector device according to claim 1 , wherein the pressure during injection into the subject is in a range of 100 to 4000 psi.

13. A method of administering a pharmaceutical composition with an auto-injector device, comprising the following steps:
providing an auto-injector device comprising a pre-filled syringe and a firing mechanism,
wherein the pre-filled syringe comprises a stainless steel needle and a glass container,
wherein the container is filled with 1 mL of a pharmaceutical composition comprising epinephrine, a buffer, and water,
wherein the buffer is configured to buffer in a pH range between 3 and 4,
wherein the needle is made from high corrosion resistance steel and is adhered to the container by means of a urethane acrylate or urethane methacrylate acrylic light cure adhesive,
wherein the urethane acrylate or urethane methacrylate acrylic light cure adhesive is configured to provide a pull out resistance of the needle relative to the container which is between 30 N to 100 N, preferably between 50 N to 70 N, more preferably greater than 60 N after 90 days exposure to the pharmaceutical composition at 40° C. and 75% RH, and
activating the firing mechanism to expel the pharmaceutical composition from the pre-filled syringe and to inject it into a subject, wherein the auto-injector device is configured to deliver about 0.3 ml of the pharmaceutical composition during the injection in below 0.5 sec.

14. The method according to claim 13 , wherein the pharmaceutical composition is for the treatment of an anaphylactic event.

Assignees

• Teva Pharma

Inventors

• Joguparthi Vijay
• Lobrutto Rosario

Classifications

• B65B55/14

  by heat · CPC title

• C09J175/04

  Polyurethanes · CPC title

• C09J175/16

  having terminal carbon-to-carbon unsaturated bonds · CPC title

• B65B3/003

  Filling medical containers such as ampoules, vials, syringes or the like · CPC title

• A61M5/329

  characterised by features of the needle shaft · CPC title