Lubricant Coating for Medical Container

Abstract

The invention relates to a lubricant coating for a medical container comprising a cross-linked lubricant composition comprising a mixture of non-reactive silicone with reactive silicone, characterized in that the reactive silicone comprises a mixture of vinyl-based silicone and acrylate-based silicone. The invention further relates to a lubricant composition usable as an intermediate product in the fabrication of a lubricant coating. The invention further relates to a medical container comprising a barrel and a stopper in gliding engagement within the barrel, comprising such a lubricant coating. The invention also relates to a process of manufacturing a medical container comprising a barrel and a stopper in gliding engagement within the barrel including depositing a lubricant composition on the inner surface of the barrel and/or on the stopper, and irradiating the coated barrel and/or stopper so as to cross-link the lubricant composition to form a lubricant coating.

1 . A lubricant coating for a medical container comprising a cross-linked lubricant composition comprising a mixture of non-reactive silicone and reactive silicone, wherein the reactive silicone comprises a mixture of vinyl-based silicone and acrylate-based silicone, wherein the vinyl-based silicone is between 8 and 15 weight %, and the acrylate-based silicone is between 2 and 5 weight % relative to the total weight of the lubricant composition. 
     
     
         2 . The lubricant coating of  claim 1 , wherein the non-reactive silicone is between 80 and 90 weight % relative to the total weight of the lubricant composition. 
     
     
         3 . The lubricant coating of  claim 1 , wherein the vinyl-based silicone is 10 weight % and the acrylate-based silicone is 3 weight % relative to the total weight of the lubricant composition. 
     
     
         4 . The lubricant coating of  claim 1 , wherein the non-reactive silicone is poly-(dimethylsiloxane). 
     
     
         5 . The lubricant coating of  claim 1 , wherein the vinyl-based silicone comprises a trimethylsilyl-terminated vinylmethylsiloxane-dimethylsiloxane copolymer. 
     
     
         6 . The lubricant coating of  claim 1 , wherein the acrylate-based silicone comprises a trimethylsilyl-terminated acryloxypropylmethylsiloxane-dimethylsiloxane copolymer. 
     
     
         7 . The lubricant coating of  claim 1 , wherein the lubricant composition has a gel structure, the gel structure comprising a three-dimensional solid structure formed of cross-linked reactive functional groups of the reactive silicone and a liquid phase comprising non-reactive silicone, the liquid phase being retained within the three-dimensional solid structure. 
     
     
         8 . The lubricant coating of  claim 1 , wherein the lubricant composition has a gel structure comprising a gel fraction of between 25 and 55 weight %. 
     
     
         9 . The lubricant coating of  claim 1 , having a shear viscosity between 500 and 2,000 Pa·s for a shear rate of 0.1 rad/s at 25° C. 
     
     
         10 . The lubricant coating of  claim 1 , having a phase angle between 20° and 40° for a shear rate of 0.1 rad/s at 25° C. 
     
     
         11 . A lubricant composition for a medical container comprising a mixture of non-reactive silicone with reactive silicone, wherein the reactive silicone comprises a mixture of vinyl-based silicone and acrylate-based silicone, wherein the vinyl-based silicone is between 8 and 15 weight %, and the acrylate-based silicone is between 2 and 5 weight % relative to the total weight of the lubricant composition. 
     
     
         12 . The lubricant composition of  claim 11 , wherein the non-reactive silicone is between 80 and 90 weight % relative to the total weight of the lubricant composition. 
     
     
         13 . The lubricant composition of  claim 11 , wherein the vinyl-based silicone is 10 weight %, and the acrylate-based silicone is 3 weight % relative to the total weight of the lubricant composition. 
     
     
         14 . The lubricant composition of  claim 11 , wherein the non-reactive silicone is poly-(dimethylsiloxane). 
     
     
         15 . The lubricant composition of  claim 14 , wherein the viscosity of the poly-(dimethylsiloxane) is 12,500 cSt at 25° C. 
     
     
         16 . The lubricant composition of  claim 11 , wherein the vinyl-based silicone comprises a trimethylsilyl terminated vinylmethylsiloxane-dimethylsiloxane copolymer. 
     
     
         17 . The lubricant composition of  claim 11 , wherein the acrylate-based silicone comprises a trimethylsilyl terminated acryloxypropylmethylsiloxane-dimethylsiloxane copolymer. 
     
     
         18 . A method of manufacturing a medical container comprising a barrel having an inner surface and a stopper in gliding engagement with at least a portion of the inner surface of the barrel, comprising the steps of:
 depositing a lubricant composition on at least one of the inner surface of the barrel and the stopper, wherein the lubricant composition comprises a mixture of non-reactive silicone with reactive silicone, the reactive silicone comprising a mixture of vinyl-based silicone and acrylate-based silicone, wherein the vinyl-based silicone is between 8 and 15 weight %, and the acrylate-based silicone is between 2 and 5 weight % relative to the total weight of the lubricant composition, and   irradiating at least one of the barrel and the stopper so as to cross-link the lubricant composition to form a lubricant coating.   
     
     
         19 . The method of  claim 18 , wherein the step of irradiating comprises using Gamma irradiation. 
     
     
         20 . The method of  claim 19 , wherein the Gamma irradiation is produced by a Cobalt-60 source. 
     
     
         21 . The method of  claim 18 , wherein the method further comprises subjecting the medical container to at least one autoclave treatment after the step of forming a coating.