- Active pharmaceutical ingredient characterization
- Compatibility studies by differential scanning calorimetry (DSC)
- Particles size analysis (Laser Granulometry dry way, liquid way)
- Rheology studies
- In vitro/In vivo correlation studies
Before the formulation stage, the characterization of the API is a sensitive step. Whether it is a New Chemical Entity or a mature API, Galenix can help with the characterization and the building up of the Drug Master File (DMF) which is deemed necessary for the final registration process.
Thanks to a wide range of equipment, highly skilled professionals and an important network of experts, Galenix can also source the drug substance on its customer’s behalf.
Preformulation is a critical step that can be achieved with very small quantities of API, few grams, for the first development tests.
Equipment for formulation screening :
- USP type III dissolutest for high-performance screening of oral forms
- Frantz cells for testing tests membrane permeation to drug substances and drug products.
The great help of Drug Delivery Systems: Galenix’s patented DDS may help deisgn a more practical dosage form, modify the release profile and/or enhance the drug’s bioavailability
- Pro-C-epT : High Shear granulator MI-PRO 250- This equipment enables to develop the first formulas with a few grams of API.
- Mixer Granulator Dryer : ROTOLAB Zanchetta
- Fluid bed dryer : Glatt