ADIENNE’s patented Multi Chamber Flexible Bag defines a new generation of ready to use cytotoxic injectable products.
Integrated into the single flexible container, a cytotoxic drug as lyophilized powder or concentrated solution, can be aseptically reconstituted by its specific solvent/s through a fast, accurate, needle free activation, to be diluted and directly administered.
Driven by the need to improve health care professional safety standards, this innovative combination products generation avoids drug manipulation, eliminates possible spillages and aerosol during the reconstitution and dose adjustment practices, protects medical personnel by the risks of exposure to high potent or cytotoxic drugs.
Designed to be activated at time of use, ADIENNE’s Multi Chamber Flexible Bags pursue and inspire a new frontier of domestic administration in oncology.
The technology applied aims to preserve and maximize the stability of poorly stable drugs up to the moment of use, simplifying the complexity of the traditional reconstitution and dose adjustment practices, minimizing the number of steps, significantly reducing the lead time between preparation and infusion of large volume parenteral drugs to patients.
Device and Process have been specifically developed to directly carry out the lyophilization of water unstable drugs, to aseptically fill and host solvent and diluents, to accurately reconstitute and administer the combination product at once, in the same flexible primary container.
ADIENNE’s Multi Chamber Flexible Bags support the following features:
- Activation of the combination product realized by peel seal technology.
- Ready to use aseptic reconstitution and dilution practice (needle free and transferring free).
- Primary container material designed around API and solvents, with similar chemical & physical drug contact properties to glass.
- Faster reconstitution of lyophilized powder and/or error-free dilution of concentrated powder or liquids drugs maximize drug preservation until and along the administration.
- Flexible Clear plastic film and regular shape allow to perform and check complete reconstitution of drug.
- Error free in reconstitution of all the drug amount.
- Void overdosages of API and solvents due to the standard reconstitution practices.
- Suitable for dose adjustment.
- Suitable for activation at time of use, avoids useless holding and storing time for reconstituted powder in intermediated reconstitution diluent.
- Activated at time of use without the need safety hoods or cleanroom environment.
- Product and device are designed together around final target combinational product dose profile
- Maximize stability and shelf life of unstable drugs due to its high performant oxygen and water vapor barrier.
- The flatness of the active chambers design allows to neutralize the negative impact of head space effect of standard primary packaging container for poor stable lyophilized products.
- Provide continuous preservation to the diluted drug with an appropriate barrier along all the administration, preserving the efficacy and stability of the active ingredient.
- Suitable for combination therapies from a single device.
- Suitable for continuous flow slow injection, bolus and long duration injections, is compatible with continuous volumetric pump.
COMPLIANCE
- PVC and DEHP-free films available compliant with US and EU Pharmacopeias.
- Sterile aseptic fill and finish manufacturing process
- Availability and suitability of Thermal Terminal sterilization products
- Multiple Luer Lock dose adjustment and twist-off ports compatible with US and EU spike devices.
SUITABILITY
ADIENNE operates as an integrated CDMO, contact us to check the suitability of your product with our devices and design your combination product in our lab scale development plant.
