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Pre-formulation and formulation activities include
Management of fast pre-formulation and formulation trials
- Inner small lab or partner's lab (CRO, univerisity) depending of the pharmaceutical form
- PoC formulation
Retro-engineering studies for generic development
Formulation development
- Excipient screening
- Manufacturing process screening
QbD approach
- CQAs and CPPs screening according to ICH Q8.
- Design of Experiments.
Non-GMP small scale manufacturing
Original Product and Generic
Active Pharmaceutical Ingredient
Active Pharmaceutical Ingredient
- Pre-formulation studies
- Characterization
- Retro-engineering
Active Pharmaceutical Ingredient
Active Pharmaceutical Ingredient
Active Pharmaceutical Ingredient
- Small molecule
- Herbal
- Combination drug
Pharmaceutical Dosage Form
Active Pharmaceutical Ingredient
Pharmaceutical Dosage Form
- Solid
- Semi-solid
- Liquid
Route of Administration
Immediate and Modified Release
Pharmaceutical Dosage Form
- Oral
- Topical
- Parenteral
- Inhalable
- ...
Immediate and Modified Release
Immediate and Modified Release
Immediate and Modified Release
- Fast release dosage form (dispersible, oro-dispersible, effervescent,..., tablets)
- Sustained or extended release (matrix, coated tablets or multiparticulates)
- Delayed release (tablet, capsule, multiparticulates)
Process Development
Immediate and Modified Release
Immediate and Modified Release
- Dry blending
- Granulation and drying (Fluidbed)
- Compression
- Film coating
- Solubilisation
- Moist heat Sterilization
- Biphasic semi-solid preparation
- Hot-melt extrusion
- ...