http://rdf.ncbi.nlm.nih.gov/pubchem/patent/DE-202021102503-U1
Outgoing Links
| Predicate | Object |
|---|---|
| assignee | http://rdf.ncbi.nlm.nih.gov/pubchem/patentassignee/MD5_ae55bc8896586571753753f5cc651977 |
| classificationCPCAdditional | http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/A61M5-001 http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/A61M5-178 |
| classificationCPCInventive | http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/A61K47-02 http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/A61K9-0019 http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/A61P13-10 http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/A61K31-216 |
| classificationIPCInventive | http://rdf.ncbi.nlm.nih.gov/pubchem/patentipc/A61K31-216 http://rdf.ncbi.nlm.nih.gov/pubchem/patentipc/A61P13-10 http://rdf.ncbi.nlm.nih.gov/pubchem/patentipc/A61M5-31 |
| filingDate | 2021-05-07-04:00^^<http://www.w3.org/2001/XMLSchema#date> |
| publicationDate | 2022-08-01-04:00^^<http://www.w3.org/2001/XMLSchema#date> |
| publicationNumber | DE-202021102503-U1 |
| titleOfInvention | syringe sterilization |
| abstract | Sterile oxybutynin-containing composition (final composition), in particular for use in the prophylactic and/or therapeutic treatment of neurogenic bladder dysfunctions, in particular neurogenic bladder emptying disorders, preferably neurogenic bladder dysfunctions associated with detrusor hyperactivity and/or detrusor-sphincter dyssynergia, the oxybutynin-containing composition according to a Process for the preparation of the sterile oxybutynin-containing composition in a preferably ready-to-use piston syringe, in particular a disposable piston syringe, and/or for the production of a preferably ready-to-use, sterile piston syringe filled with the oxybutynin-containing composition, in particular a disposable piston syringe, is available and/or obtained; and/orwherein the oxybutynin-containing composition is heat-sterilized by a process for producing the 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 , in particular steam sterilized, preferably steam sterilized, preferably terminally (heat, steam, steam) sterilized, wherein the plunger syringe has a syringe body, in particular syringe barrel, on the one hand and a syringe plunger with a plunger stopper on the other hand, wherein the syringe body, in particular syringe barrel, is formed from a polypropylene (PP), andwherein the oxybutynin-containing final composition obtained after the end of the process, in particular after process step b), as a sterile aqueous composition, in special terminally sterilized composition, and has the following specifications (i) and (ii) and/or (iii), preferably (i), (ii) and (iii): (i) specified specification concentration of oxybutynin , preferably in the form of the hydrochloride (oxybutynin hydrochloride, oxybutynin-HCl), with a specified deviation of at most ± 5%, based on the concentration of oxybutynin, (ii) specified specification pH value with a specified deviation of at most ± 0.5 pH- units of value,(iii) predetermined specification maximum amount of oxybutynin degradation product(s), in particular reactively induced oxybutynin degradation product(s), preferably hydrolytically and/or oxidatively induced oxybutynin degradation product(s), preferably phenylcyclohexylhydroxyacetic acid (impurity D); the method comprising the following steps:a) providing a starting composition containing oxybutynin in the syringe and/or filling the syringe with a starting composition containing oxybutynin and subsequentlyb) heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) Sterilization of the starting composition containing oxybutynin in the syringe and/or the syringe filled with the starting composition containing oxybutynin to obtain the sterile end composition containing oxybutynin in the preferably ready-to-use syringe and/or to obtaining the preferably ready-to-use, sterile syringe filled with the composition containing oxybutynin, wherein the im Process, in particular in process step b), migration and/or storage of the oxybutynin that occurs in the syringe body, in particular the syringe cylinder, and/or in d en piston stopper, 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 (impurity D), controlled and /or is compensated in such a way and with the proviso that the sterile oxybutynin-containing final composition obtained after carrying out process step b) meets the aforementioned specifications (i) and (ii) and/or (iii), preferably (i), (ii) and ( iii), and 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. |
| priorityDate | 2021-04-24-04:00^^<http://www.w3.org/2001/XMLSchema#date> |
| type | http://data.epo.org/linked-data/def/patent/Publication |
Incoming Links
Total number of triples: 28.