Pre-filled syringe

Abstract

An auto-injector device includes a pre-filled syringe including a container and a stainless steel needle adhered to the container with at least one of a urethane acrylate adhesive or a urethane methacrylate adhesive. The container is filled with at least 1 mL of a pharmaceutical composition comprising epinephrine, a buffer, and water, where the pharmaceutical composition has a pH ranging between 3 and 4. The auto-injector device also includes a firing mechanism that expels about 0.3 mL of the pharmaceutical composition from the container in less than 0.5 seconds during a single injection.

1 . An auto-injector device comprising:
 a pre-filled syringe comprising a container and a stainless steel needle adhered to the container with at least one of a urethane acrylate adhesive or a urethane methacrylate adhesive, the container being filled with at least 1 mL of a pharmaceutical composition comprising epinephrine, a buffer, and water, wherein the pharmaceutical composition has a pH ranging between 3 and 4; and   a firing mechanism configured to expel about 0.3 mL of the pharmaceutical composition from the container in less than 0.5 seconds during a single injection.   
     
     
         2 . The auto-injector device of  claim 1 , wherein the container is a glass container. 
     
     
         3 . The auto-injector device of  claim 1 , wherein the urethane acrylate adhesive or the urethane methacrylate adhesive is a light cure adhesive. 
     
     
         4 . The auto-injector device of  claim 1 , wherein the concentration of the epinephrine in the pharmaceutical composition is between 0.9 and 1.1 mg/mL for adult patients. 
     
     
         5 . The auto-injector device of  claim 1 , wherein the concentration of the epinephrine in the pharmaceutical composition is between 0.4 and 0.6 mg/mL for pediatric patients. 
     
     
         6 . The auto-injector device of  claim 1 , wherein the buffer comprises at least one of bicarboxylic acid, tartrate salt, or sodium tartrate dihydrate. 
     
     
         7 . The auto-injector device of  claim 1 , wherein the pharmaceutical composition further comprises an antioxidant. 
     
     
         8 . The auto-injector device of  claim 7 , wherein the antioxidant comprises sodium metabisulfite. 
     
     
         9 . The auto-injector device of  claim 8 , wherein the concentration of the sodium metabisulfite in the pharmaceutical composition is about 1.2 mg/mL. 
     
     
         10 . The auto-injector device of  claim 1 , wherein the pharmaceutical composition further comprises a pH adjuster. 
     
     
         11 . The auto-injector device of  claim 10 , wherein the pH adjuster comprises hydrochloric acid. 
     
     
         12 . The auto-injector device of  claim 1 , wherein the pharmaceutical composition further comprises a tonicity adjuster. 
     
     
         13 . The auto-injector device of  claim 12 , wherein the tonicity adjuster comprises sodium chloride. 
     
     
         14 . The auto-injector device of  claim 1 , wherein the firing mechanism is further configured to expel the pharmaceutical composition from the container at a pressure ranging between 100 psi and 4000 psi. 
     
     
         15 . The auto-injector device of  claim 1 , wherein the stainless steel needle comprises 15 to 20% Cr, 8 to 16% Ni, and 3 to 4% Mo. 
     
     
         16 . The auto-injector device of  claim 1 , wherein the stainless steel needle comprises 15 to 20% Cr, 20 to 30% Ni, and 3 to 6% Mo. 
     
     
         17 . The auto-injector device of  claim 1 , wherein the stainless steel needle is hollow and has an inner diameter between 0.39 to 0.53 mm. 
     
     
         18 . The auto-injector device of  claim 1 , wherein, after the urethane acrylate adhesive or the urethane methacrylate adhesive is exposed to the pharmaceutical composition for 90 days at 40° C. and 75% relative humidity, the urethane acrylate adhesive or the urethane methacrylate adhesive is configured to resist a pull out force of between 30 N and 100 N applied to at least one of the stainless steel needle or the container. 
     
     
         19 . The auto-injector device of  claim 1 , wherein, after the urethane acrylate adhesive or the urethane methacrylate adhesive is exposed to the pharmaceutical composition for 90 days at 40° C. and 75% relative humidity, the urethane acrylate adhesive or the urethane methacrylate adhesive is configured to resist a pull out force of between 50 N and 70 N applied to at least one of the stainless steel needle or the container. 
     
     
         20 . The auto-injector device of  claim 1 , wherein, after the urethane acrylate adhesive or the urethane methacrylate adhesive is exposed to the pharmaceutical composition for 90 days at 40° C. and 75% relative humidity, the urethane acrylate adhesive or the urethane methacrylate adhesive is configured to resist a pull out force greater than 60 N applied to at least one of the stainless steel needle or the container.