Medical container for accommodating protein solution formulation
A medical container for accommodating a protein solution formulation, in which the medical container is formed from a cycloolefin polymer, sterilized with high-pressure steam, and suppresses oxidization of amino acid residues in a protein in a protein solution formulation accommodated in the medical container.
1. A product comprising:
a sterilized medical container that suppresses oxidization of amino acid residues, wherein the medical container consists essentially of a cycloolefin polymer and was sterilized with high-pressure steam; and
a stable protein solution accommodated in the medical container, wherein the protein solution comprises a protein selected from the group consisting of erythropoietin, a granulocyte colony-stimulating factor, thrombopoietin, a tissue plasminogen activator, a stem cell growth factor, an interferon, and an interleukin, and wherein 5% or less of methionine residues in the protein are oxidized immediately after accommodation in the medical container and for at least 4 weeks thereafter.
2. A product of claim 1 ,
wherein the medical container has a radical content of 2.2×10 15 radical/g or less as measured using an electron spin resonance spectrometer.
3. The product of claim 2 ,
wherein the medical container suppresses oxidization of amino acid residues in a protein in a protein solution formulation accommodated in the medical container.
4. The product according to claim 1 , wherein the cycloolefin polymer is a hydrogenated ring-opened polymer.
5. The product according to claim 2 , wherein the cycloolefin polymer is a hydrogenated ring-opened polymer.
6. The product according to claim 3 , wherein the cycloolefin polymer is a hydrogenated ring-opened polymer.
7. The product according to claim 1 , wherein the medical container is a syringe or cartridge.
8. The product according to claim 2 , wherein the medical container is a syringe or cartridge.
9. The product according to claim 3 , wherein the medical container is a syringe or cartridge.
10. The product according to claim 4 , wherein the medical container is a syringe or cartridge.
11. The product according to claim 1 , wherein the protein is erythropoietin.
12. The product according to claim 1 , wherein the medical container is a syringe.
13. A packaged product comprising:
the product of claim 1 ; and
a substantially oxygen-impermeable packaging material in which the product is sealed and packaged along with a deoxygenating agent.
14. The packaged product according to claim 13 , wherein an oxygen absorption capacity of the deoxygenating agent is one-fifth or more of a volume of a storage space within the packaging material.
15. The packaged product according to claim 13 , wherein the packaged product a blister package.
16. The packaged product according to claim 13 , wherein the substantially oxygen-impermeable packaging material has a light-blocking property.
17. The packaged product according to claim 13 , further comprising an outer packaging material in which the oxygen-impermeable packaging material is contained, the outer packaging material having a light-blocking property.