FIELD: medicine.
SUBSTANCE: present invention relates to a pre-filled glass container, such as a pre-filled glass syringe containing an aqueous composition of botulinum toxin. Described is a pre-filled glass syringe containing an aqueous botulinum toxin composition, the syringe comprising (a) a syringe barrel made of glass having a proximal end, a distal end and a substantially cylindrical wall extending therebetween, forming a cylinder opening, wherein the syringe barrel has a distally projecting cannula with a liquid passage extending therethrough communicating with the cylinder opening, the substantially cylindrical wall having an inner surface optionally coated with a barrier layer, (b) a closure device having an exit fastening portion that tightly connects and closes the distal open end of the syringe, wherein the outlet fastening part is made from an elastomeric material with an optionally coated surface, and (c) a piston rod assembly that extends into the proximal end of the syringe cylinder and includes a piston seal in a fluid-free sliding joint with a cylindrical clearance of the cylinder, wherein the piston seal is made of an elastomeric material with a coating which is optionally applied on at least a portion of the sealant of the piston, contacting with an aqueous composition of botulinum toxin during storage and/or injection, in which the elastomeric material of the outlet fastener is selected from isoprene rubber (IS), butadiene rubber (BR), butyl rubber, halogenated butyl rubber, butadiene-styrene rubber and mixtures thereof, and the elastomeric material of the piston sealer is selected from isoprene rubber (IS), butadiene rubber (BR), butyl rubber, halogenated butyl rubber, butadiene-styrene rubber and mixtures thereof, and wherein toxin activity does not decrease by more than 25 % relative to the initial activity of the toxin after storing the pre-filled glass syringe for 12 months at 5 °C, or 12 months at 25 °C, or 6 months at 30 °C.
EFFECT: technical result is an aqueous composition of botulinum toxin in a pre-filled container is stable for a long period of time at temperature ranging from low to ambient temperature.
14 cl, 4 tbl, 3 dwg
