In-use stability: How is the impact of product-handling?
In a clinical setting, a drug product may be diluted and encounters different surface materials (such as tubings, infusion bags, pumps, closed system drug transfer devices) before it is finally administered to the patient.
Therefore, formulation development needs to assess the stability of a formulation after dilution as well as its compatibility with commonly used clinical diluents and clinical materials.
In-use stability studies are crucial because dilution of excipients can lead to a loss of product stability and thus therapeutic efficacy. Also, adsorption of the drug substance to surface materials and variations in extractable volume can negatively impact dosing. Furthermore, during an in-use stability study, the introduction of subvisible particles either by aggregation of the drug substance or via the surface materials will be investigated. In-use stability is usually done with a selection of the most promising drug product candidates using fresh as well as aged material to assess the stability up to 24 h.
Crucial parameters during in-use stability study may include the following:
- Effect of the dilution factor
- Effect of the dilution media
- Adsorption to surfaces
- Shear-forces during application
- Effect at the injection site
- Silicone oil contact
- Extractable volume
Coriols offers in-use stability studies on various levels, which can be tailored to customer needs:
- R&D level: Full flexibility following our internal Good Research Practice Guidelines
- Enhanced R&D level: Controlled environment and qualified equipment with full R&D flexibility
- GMP level: GMP environment with full QA involvement