Tailor-made transfer systems
Successful reconstitution of lyophilized medications depends crucially on the properties of the active substance as well as the solvent. That's why transfer systems are available with parameters that can be individually adapted. The nextaro® premium transfer system can be tailored to your specific requirements.
Protein-based medications (such as coagulation factors) can be stored more safely and last longer with freeze-drying (lyophilization). Modern transfer systems make reactivation of lyophilized substances easy and reliable for the user. Transfer systems need to be easily adaptable to the specific requirements of the application because the physical properties of the active substances and the solvents can differ.
The solubility of the active substance as well as the volume and viscosity of the solvent are decisive for successful reconstitution of lyophilized medications. The angle and force with which the jet of liquid hits the lyophilized cake are particularly important. If the jet is too strong, foam may form and cause denaturation or clumping of the active substance. Ideally, the jet of solvent is directed gently down the walls of the vial in order to dissolve the active substance slowly from below. Adjustment of the transfer rate is therefore essential for complete reconstitution and standardized concentration of the active substance in the prepared solvent.
To maintain a regulated transfer speed of the solution when reconstituting a lyophilized medication, the nextaro® premium transfer system contains an integrated throttle, which can be implemented to match your individual requirements. This ensures that, through customizing and specifying the internal geometry and thus the flow characteristics, the liquid jet will be adapted specifically to the solvent volume and the solubility of the active substance. This gentle form of reconstitution prevents foaming, clumping and denaturation.
At sfm medical devices GmbH, we help you to develop a reliable reconstitution kit for your customers that is safe, robust and intuitive to use, and is suitable for the clinic as well as the home care sector. We will find the right parameters for your application of the nextaro® premium transfer system. To do this, we carry out individual tests and adjust the nextaro® premium transfer system to the properties of your specific components. The result is an optimized overall concept that can be implemented as a standard product.
- Kagdi R, Le K, Doucet D et al. Determination of Holdup Volume and Transient Contact Compatibility of Closed System Transfer Devices for a Reconstituted Lyophilized Drug Product. J Pharm Sci 2020; 109: 3504-3511. https://www.ncbi.nlm.nih.gov/pubmed/32771346
- Nurgat ZA, Lawrence M, Elhassan TA et al. Comparison of closed system transfer devices for turnaround time and ease of use. J Oncol Pharm Pract 2019; 25: 1142-1151. https://www.ncbi.nlm.nih.gov/pubmed/29958506
- Petoskey F, Kwok SC, Jackson W et al. Overcoming Challenges of Implementing Closed System Transfer Device Clinical In-Use Compatibility Testing for Drug Development of Antibody Drug Conjugates. J Pharm Sci 2020; 109: 761-768. https://www.ncbi.nlm.nih.gov/pubmed/31376374