Galenix Drug Delivery Solutions, Drug Product Development, Licencing-Out Opportunities

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Preformulation


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  • Preformulation
  • Active pharmaceutical ingredient characterization
  • Compatibility studies by differential scanning calorimetry (DSC)
  • Microscopy
  • 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.


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Microscopic Powder Study

Preformulation Equipement

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

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Franz Cell Equipment For Transmucosal and Transdermal Technologies


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GLATT Fluid Bed Dryer

Preformulation Equipement

  • 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