Method for producing a sterile
oxybutynin-containing composition in a preferably ready-to-use
piston syringe, in particular a disposable
piston syringe, and / or for producing a preferably ready-to-use, sterile
piston syringe filled with an
oxybutynin-containing composition, in particular a disposable piston syringe, wherein the piston syringe has a syringe body on one side and a syringe piston with a piston stopper on the other, wherein the syringe body is made of
polypropylene, and wherein the final
oxybutynin-containing composition obtained after completion of the process, in particular after process step b), is formed as a sterile aqueous composition, in particular a terminally sterilized composition, and has the following specification requirements (i) and (ii) and / or (iii), preferably (i), (ii) and (iii): (i) specified concentration of oxybutynin, preferably in the form of the
hydrochloride, with a specified deviation of not more than ± 5%, based on the concentration of oxybutynin, (ii) specified specification pH value with a specified deviation of not more than ± 0.5 pH units, (iii) specified maximum quantity of oxybutynin degradation product(s), in particular reactively generated oxybutynin degradation product(s), preferably hydrolytically and / or oxidatively generated oxybutynin degradation product(s), preferably phenylcyclohexylhydroxyacetic acid; the procedure includes the following steps: a) Providing an oxybutynin-containing starting composition in the piston syringe and / or filling the piston syringe with an oxybutynin-containing starting composition and subsequently b) Heat sterilization, in particular
steam sterilization, preferably
steam sterilization, preferably
terminal sterilization, of the oxybutynin-containing starting composition in the syringe and / or the syringe filled with the oxybutynin-containing starting composition to obtain the sterile oxybutynin-containing final composition in the preferably ready-to-use syringe and / or to obtain the preferably ready-to-use, sterile syringe filled with the oxybutynin-containing composition, wherein the migration and / or incorporation of the oxybutynin into the syringe body and / or the
plunger stopper occurring in the process, in particular in process step b), and / or the degradation of the oxybutynin occurring in the process, in particular in process step b), in particular the reactive degradation of the oxybutynin, preferably the hydrolytically and / or oxidatively induced degradation, preferably the degradation to phenylcyclohexylhydroxyacetic acid, is controlled and / or compensated in such a manner and with the proviso that that the sterile oxybutynin-containing final composition obtained after carrying out process step b) meets the previously mentioned specification requirements (i) and (ii) and / or (iii), preferably (i), (ii) and (iii), and that the sterile oxybutynin-containing final composition is obtained in the preferably ready-to-use piston syringe or the preferably ready-to-use, sterile piston syringe filled with the oxybutynin-containing final composition, wherein the migration and / or incorporation of the oxybutynin into the syringe body and / or the
plunger stopper occurring in the process, in particular in process step b), and / or the degradation occurring in the process, in particular in process step b), in particular the reactive degradation of the oxybutynin, preferably the hydrolytically and / or oxidatively caused degradation of the oxybutynin, preferably the degradation to phenylcyclohexylhydroxyacetic acid, is controlled and / or monitored, in particular prevented and / or minimized and / or compensated for, by at least one of the following measures and / or steps (1), (2), (3) and / or (4): (1) Adjustment and / or use of an increased concentration and / or amount of oxybutynin, preferably in the form of the
hydrochloride, in the initial composition compared to the specified concentration and / or amount of oxybutynin, preferably in the form of the
hydrochloride; (2) Adjustment of the pH value of the initial composition to a value that differs from the specified pH value, in particular an
increased pH value; (3) Setting and / or selecting the sterilization conditions, in particular selected from the group consisting of sterilization type, sterilization duration, sterilization temperature, sterilization pressure, sterilization
atmosphere and combinations thereof, preferably setting and / or selecting the F0 value of the sterilization; (4) Equipment and / or treatment, in particular
coating, of the syringe body, preferably the inner wall of the syringe body, and / or the
plunger stopper with at least one migration- and / or degradation-
reducing agent.