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Development steps

 Pre prescription study → solubility, stability, compatibility, log P test → solid form screening and selection → physical and chemical properties, drug development feasibility evaluation → formulation process development → formulation screening based on stability, solubility and animal PK → process selection based on physical and chemical properties of candidate drugs → study on storage and transportation conditions of candidate drugs → transfer of formulation process technology to GMP factory service → CMC application data sorting
 

Applicable dosage form

Development of various internal and external dosage forms: various slow controlled release / non slow controlled suitable tablets, injections, capsules, ointments, patches, etc
 

Technical elements

Avoiding patent products and developing innovative prescription products
Patent analysis and avoidance strategy
reverse engineering
Innovative prescription / process development
Key platform technologies:
Conventional dosage form
Delayed and controlled release dosage form
Development of formulation technology of insoluble drugs  
 

Declare

CMC related literature and regulations support
CFDA / FDA / EMA / TFDA declaration data writing
Support for ind / NDA / anda declaration documents in mainstream CTD format
 

Preparation equipment

Rotary tablet press (8 punches, 19 punches)
Double layer rotary tablet press (14 punches, B / D turret)
High shear granulator
Fluidized bed granulator dryer and coating machine
Extruding and rounding machine
Spray dryer with solvent recovery
Freeze dryer (400 vials)
Rolling dry granulator
Pelletizer
Porous rolling coating machine (1.5l-8l)
Automatic capsule filling machine (for solid, liquid and semi-solid filling)
X-powder diffractometer (powder XRD)
Differential scanning calorimeter (DSC)
Thermogravimetry (TGA)
Dynamic moisture adsorption analyzer (DVS)
Polarizing microscope
Intelligent dissolution instrument (automatic sampling, online UV detection)
ultrasonic homogenizer
High shear dispersion emulsifier
Moisture tester
High speed freezing centrifuge