Twin-chamber syringe filled with a charge of activity-sensitive human protein as active substance
AssigneeAlpha Therapeutic Corporation
InventorOtto Dittmann
Life of this patent
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Abstract
A twin-chamber syringe has a pyrogen-free sterile solvent in the chamber averted from the needle, and in the second chamber facing the needle a charge of activity-sensitive human protein, introduced and lyophilized in a single operation in the syringe, where it is stored, in a quantity necessary for therapeutically effective administration. The invention also relates to the filling of the syringe and the potential it offers for immediate use of activity-sensitive human proteins and for self-administration at home.
Claims12
A method for producing a twin-chamber syringe having a first chamber and a second chamber, said first and second chambers being separated by a rupturable barrier, said second chamber being in fluid communication with an injection needle, said first chamber containing a pyrogen-free solvent and said second chamber containing activity-sensitive human protein, comprising the steps of:
- (a) charging said second chamber with a solution of said activity-sensitive human protein of sufficient concentration to provide a single therapeutically effective dose of said protein,
- (b) lyophilizing said solution directly in said second chamber to obtain lyophilized protein in said second chamber,
- (c) filling said first chamber with pyrogen-free solvent to prepare a filled syringe, and
- (d) sterilizing said filled syringe.
Dependencies are inferred from the claim text.