Pre-filled syringe
AssigneeChugai Seiyaku Kabushiki Kaisha
InventorsRieko SHIOZAKI, Yuji YAMANAKA, Mika TAKAHASHI, Tadao YAMAZAKI, Masakazu FUKUDA, Shogo YAMASHITA
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Abstract
The purpose of the present invention is to provide a pre-filled syringe formulation with staked needle, which contains an antibody at a high concentration and can be produced on an industrial scale in a simple manner without causing clogging. A pre-filled syringe formulation with staked needle, in which a protein solution is packed. The pre-filled syringe formulation is characterized in that a cap formed with a material having low water vapor permeability is provided at the needle.
Claims15
A pre-filled syringe comprising a staked needle, wherein the pre-filled syringe is filled with a protein formulation and sealed, and wherein the pre-filled syringe further comprises a cap on the needle and the cap is made of a material having a low water vapor permeability and the water vapor permeability of the cap at 5° C. is 0.1 g/m2·day or lower.
A method of producing a pre-filled syringe comprising a staked needle, wherein the pre-filled syringe is filled with a protein formulation and sealed, and wherein the pre-filled syringe further comprises a cap on the needle and the cap comprises a material having a low water vapor permeability, the method comprising the steps of:
- (a) sterilizing a syringe with radiation or an electron beam, wherein the syringe comprises a staked needle and a cap made of a material having a low water vapor permeability, and wherein the water vapor permeability of the cap at 5° C. is 0.1 g/m2·day or lower;
- and
- (b) filling the sterilized syringe of step (a) with a protein formulation, and sealing the syringe aseptically.
Dependencies are inferred from the claim text.