Stabilized liquid protein formulations in pharmaceutical containers

Abstract

A container comprising a closure means coated by an inert fluorinated material and containing a liquid pharmaceutical composition. In particular, the container comprises a closure means coated by TEFLON (polytetrafluoruethylene (PTFE)) and contains a HSA-free Interferon-β formulation having the following composition: 30 to 100 μg/ml of interferon-β, an isotonicity agent, 0.1 to 2 mg/ml of Poloxamer 188, at least 0.12 mg/ml of L-Methionine and a buffer solution capable of maintaining the pH of the liquid formulation at a value between 3.0 and 4.0.

1. A method for containing a composition comprising providing a liquid pharmaceutical composition ready for injection and comprising an interferon β as an active ingredient into a container which is a vial, an ampoule, a small bottle or, a tube, a syringe or a cartridge with a closure stopper wherein the closure stopper is coated with polytetrafluoruethylene (PTFE) polytetrafluoroethylene. 
     
     
       2. The method according to  claim 1 , wherein the liquid pharmaceutical composition contains a bacteriostatic agent. 
     
     
       3. The method according to  claim 2 , wherein the bacteriostatic agent is benzyl alcohol. 
     
     
       4. The method according to  claim 2 , wherein the bacteriostatic agent is present at a concentration between about 2 and 9 mg/ml. 
     
     
       5. A method for containing a composition comprising providing a liquid pharmaceutical composition ready for injection and comprising a protein as an active ingredient into a container with a closure article coated with polytetrafluoruethylene polytetrafluoroethylene, wherein the pharmaceutical composition is a liquid HSA-free (human serum album) formulation comprising 30 to 100 μg/ml of interferon-β, an isotonicity agent, 0.1 to 2 mg/ml of a surfactant, at least 0.12 mg/ml of an antioxidant and a buffer solution capable of maintaining the pH of the liquid formulation at a value between 3.0 and 4.0. 
     
     
       6. A container for a liquid pharmaceutical composition containing an interferon β as active ingredient, wherein the container is a vial, an ampoule, a small bottle or, a tube, a syringe or a cartridge, and a closure stopper which is coated with polytetrafluoruethylene (PTFE) polytetrafluoroethylene. 
     
     
       7. The container according to  claim 6 , wherein the container is made of glass. 
     
     
       8. The container according to claim  6  7, wherein the internal surface of the container is coated by an inert material. 
     
     
       9. The container according to claim  6  8, wherein the inert material coating the internal glass surface of the container is silicon silicone. 
     
     
       10. The container according to  claim 6 , wherein the closure stopper is made of a rubber stopper. 
     
     
       11. The container according to  claim 6 , wherein the container is a pre-filled syringe or a cartridge for autoinjector and the closure stopper is a plunger. 
     
     
       12. A pharmaceutical product comprising a container according  claim 6 . 
     
     
       13. The container according to claim 6, wherein the container contains the liquid pharmaceutical composition with the interferon β being present in the liquid pharmaceutical composition in an amount of about 30 to about 100 μg/mL. 
     
     
       14. The container according to claim 13, wherein the liquid pharmaceutical composition further contains a bacteriostatic agent. 
     
     
       15. The container according to claim 14, wherein the liquid pharmaceutical composition further contains an isotonicity agent, a surfactant, an antioxidant and a buffer solution. 
     
     
       16. A pharmaceutical product comprising:
 a container selected from the group consisting of a syringe, a cartridge, a vial, a bottle and a tube;   a liquid pharmaceutical composition comprising interferon β as active ingredient; and   a closure coated with polytetrafluoroethylene.   
     
     
       17. The pharmaceutical product of claim 16, wherein the container is a syringe or a cartridge for autoinjector and wherein the closure is a plunger. 
     
     
       18. The pharmaceutical product of claim 17, wherein the container is a pre-filled syringe. 
     
     
       19. The pharmaceutical product of claim 16, wherein said liquid pharmaceutical composition further comprises a bacteriostatic agent. 
     
     
       20. The pharmaceutical product of claim 19, wherein the liquid pharmaceutical composition further comprises an isotonicity agent, a surfactant, an antioxidant and a buffer solution. 
     
     
       21. The pharmaceutical product of claim 16, wherein said container is made of glass. 
     
     
       22. The pharmaceutical product of claim 21, wherein the internal surface of the container is coated by an inert material. 
     
     
       23. The pharmaceutical product of claim 22, wherein the inert material coating the internal glass surface of the container is silicone. 
     
     
       24. A pharmaceutical product comprising:
 a container;   a liquid pharmaceutical composition ready for injection and comprising interferon β as active ingredient; and   a closure coated with polytetrafluoroethylene.   
     
     
       25. The pharmaceutical product of claim 24 wherein the liquid pharmaceutical composition is HSA-free (human serum albumin), and comprises 30 to 100 μg/mL of interferon β, an isotonicity agent, 0.1 to 2 mg/mL of a surfactant, at least 0.12 mg/mL of an antioxidant and a buffer solution capable of maintaining the pH of the liquid formulation at a value between 3.0 and 4.0.