US 12,434,002 B2
Botulinum toxin prefilled container
Markus Vogt, Frankfurt am Main (DE)
Assigned to Merz Pharma GmbH & Co. KGaA, Frankfurt am Main (DE)
Filed by Merz Pharma GmbH & Co. KGaA, Frankfurt am Main (DE)
Filed on Jun. 23, 2021, as Appl. No. 17/356,300.
Application 17/356,300 is a continuation of application No. 16/718,236, filed on Dec. 18, 2019, granted, now 11,167,090.
Application 16/718,236 is a continuation of application No. 15/536,503, granted, now 10,549,042, issued on Feb. 4, 2020, previously published as PCT/EP2015/002602, filed on Dec. 22, 2015.
Claims priority of application No. 14004394 (EP), filed on Dec. 23, 2014.
Prior Publication US 2021/0316077 A1, Oct. 14, 2021
Int. Cl. A61M 5/31 (2006.01); A61K 8/64 (2006.01); A61K 9/00 (2006.01); A61K 38/48 (2006.01); A61K 47/26 (2006.01); A61K 47/42 (2017.01); A61M 5/315 (2006.01); A61Q 19/08 (2006.01)
CPC A61M 5/3129 (2013.01) [A61K 8/64 (2013.01); A61K 9/0019 (2013.01); A61K 38/4893 (2013.01); A61K 47/26 (2013.01); A61K 47/42 (2013.01); A61M 5/31513 (2013.01); A61Q 19/08 (2013.01); C12Y 304/24069 (2013.01); A61K 2800/87 (2013.01); A61K 2800/91 (2013.01); A61M 2005/3131 (2013.01); A61M 2205/0222 (2013.01); A61M 2205/0238 (2013.01)] 15 Claims
 
1. A method for the cosmetic treatment of the skin, the method comprising administering an effective amount of botulinum toxin to a patient using a prefilled glass syringe comprising an aqueous botulinum toxin formulation,
wherein the glass syringe comprises
(a) a syringe barrel made of glass including a proximal end and a distal end, and a cylindrical wall extending therebetween and defining a barrel lumen, the syringe barrel having a distally projecting tip with a fluid passage extending therethrough and communicating with the barrel lumen, wherein the cylindrical wall has an interior surface optionally coated with a barrier layer,
(b) a capping device having an outlet engaging portion sealingly engaging and closing the distal open outlet end of the syringe, wherein the outlet engaging portion is made of an elastomeric material that optionally has a coating on its surface, and
(c) a plunger rod assembly which extends into the proximal end of the syringe barrel and includes a plunger stopper in sliding fluid-tight engagement with the cylindrical wall of the barrel lumen, wherein the plunger stopper is made of an elastomeric material, which optionally has a coating on at least a portion of the plunger stopper that contacts the aqueous botulinum toxin formulation during storage and/or injection,
wherein the elastomeric material of the outlet engaging portion is selected from isoprene rubber (IS), butadiene rubber (BR), butyl rubber, halogenated butyl rubbers, styrene-butadiene rubber, and mixtures thereof, and the elastomeric material of the plunger stopper is selected from isoprene rubber (IS), butadiene rubber (BR), butyl rubber, halogenated butyl rubbers, styrene-butadiene rubber, and mixtures thereof, and
wherein the toxin activity is not reduced by more than 25%, relative to the initial toxin activity, upon storage of the prefilled glass syringe for 12 months at 5° C. or 12 months at 25° C.