Are you in the process of obtaining marketing authorisation for your product?
Do you want to sustain your marketing authorisation for a longer time?
Are you looking to save on human resources?
We can assist with:
- Planning of the studies
- Performing measurements of the stability samples stored in the client premises
- Reporting and interpretation of the results
We include testing of the drug product attributes that are susceptible to change during storage and are likely to influence the quality, safety, or efficacy (ICH Q1A):
- Particle size distribution
- Polymorphic form
- Melting point
- Other physical properties
The stability studies conducted to demonstrate the critical quality attributes do not change during the shelf-life of the drug substance/drug product. REF:
ICH Q1A (R2) Stability testing of new drug substances and drug products | European Medicines Agency (europa.eu)
Do you need to select the optimal form for pharmaceutical development?
We will evaluate the risks during development needed to select the solid-state form for pharmaceutical development.
If you select the complete package, it will include:
- Selection of storage conditions and duration of the studies based on your requirements
- Planning of relative stability studies (slurry) supporting the polymorphic form selection process
- Conducting the studies
- Reporting and interpretation of results
- Planning of stress solid-state stability studies of solid-state forms
- Measurements, interpretation, and reporting
Upon your request, we can include the stability of polymorphic form towards mechanical stress:
Cha J, Gilmor T, Lane P, Ranweiler JS, (2011) 12-Stability Studies in Ahuja S, Scypinski S, Handbook of Modern Pharmaceutical Analysis, 10: 459-505.
Lin S Y, Hsu C H, Ke W T (2010). Solid-state transformation of different gabapentin polymorphs upon milling and co-milling. Int J Pharm, 396 (1–2): 83-90.
Seryotkin Y V, Drebushchak T N, Boldyreva E V (2013). A high-pressure polymorph of chlorpropamide formed on hydrostatic compression of the α-form in saturated ethanol solution. Acta Cryst. B69: 77-85.