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Drug Product Development

Pre-formulation

•  Physicochemical properties: solubility, pKa, logP, hygroscopicity

•  Screening: polymorph, salt, cocrystal, amorphous dispersion

•  Solid state/solution stability: heat, humidity, light, pH, oxidation

•  Preclinical formulation

Formulation

•  Oral solid dosage form design, development

•  Drug/excipient compatibility, stability

•  Bioavailability enhancement of new drug candidate substances

•  Dosage forms include but not limited to hydrogel matrix, osmotic pump, enteric coated pellets/tablets, etc.

•  Development covering both IND and NDA


Process Development and Manufacturing

•  Development: wet/dry granulating, tableting, coating,

•  Beads drug layering/coating, lyophilization

•  Tablets and capsules production lines (5-100kg) 

•  Bottle and blister packaging lines


Enabling Technologies

• Spray Dried Dispersion (SDD)

• Hot Melt Extrusion (HME)

• Nanosuspensions

• Solid lipid nanoparticles

• Emulsions

• Micro-emulsions

• SMEDDS