Process to improve stability of a pharmaceutical composition
OwnerAndrea Fetz, Georg Ludwig Kis +1inventors
InventorsAndrea Fetz, Georg Ludwig Kis, Michel Pepiot
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Abstract
The present invention describes in particular a method for stabilizing a pharmaceutical composition by contacting said composition with a polymeric material comprising in particular an ethylene oxide sterilization step.
Claims12
Method to improve the stability of a pharmaceutical composition which is sensitive towards oxidation, comprising the steps of:
- exposing an empty PE, PP and/or PET container to ethylene oxide (ETO) at room temperature, at a concentration and for a time sufficient to achieve sterility,
- removing said ETO from said container under aseptic conditions for a period sufficient to achieve an ETO content of less than 1 ppm,
- transferring under aseptic conditions a pharmaceutical composition into said sterilized container, and
- closing said container comprising said pharmaceutical composition with a closing device.
Method of claim 1 or 6, wherein said ETO is removed for a period of 1-20 days, preferably 5-15 days, and more preferably for 8-10 days.
A process for the production of a stable pharmaceutical composition in a container, comprising the steps of:
- a) sterilizing a container, in particular a PE and/or PP container, with ethylene oxide (ETO) at room temperature, at a concentration and for a time sufficient to achieve sterility,
- b) removing said ETO from said container under aseptic conditions for a period sufficient to achieve an ETO content of less than 1 ppm, for example under air diffusion conditions,
- c) transferring under aseptic conditions a pharmaceutical composition into said sterilized container, and
- d) closing said container comprising said pharmaceutical composition with a closing device.
Use of an ETO (ethylene oxide) sterilized PE, PP and/or PET container to improve the stability of an aqueous pharmaceutical composition, in particular to improve the stability of a composition being susceptible to oxidative degradation.
Dependencies are inferred from the claim text.