The early development department offers a full range of pharmaceutical
services for the formulation development of Rx, Generics or mature molecules (Chemicals or Biologicals)
with conventional dosage forms or complex dosage forms including:
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 work, 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 profesionnals and a 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,
a few grams, for the first development tests.
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Raw materials for development
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