Formulation Development

The Formulation Group specializes in the development of novel solid and liquid dosage forms. Liquid dosage forms such as oral solutions, suspensions, and injectables have become the focus for pre-clinical safety evaluation in the industry. We are proud to provide these services, along with oral solid dosage formulation development and manufacturing of clinical trial material, at our state-of-the-art Zhang Jiang facility. Our formulation service provides our clients with essential support for pivotal GLP studies, subsequent clinical trials, and later stage development in a timely, cost-effective manner. We have the capability and expertise to manufacture drug products suitable for Chinese SFDA and USA FDA clinical studies.

Preclinical Formulation Development

• IV/oral liquid formulations for PK, pharmacology, and non-GLP tox studies
• Integration with internal drug discovery capabilities in Medchem, Biology, DMPK, and Toxicology
• Use up-to-date technologies to optimize preclinical formulations to support drug discovery programs

Technologies for Poorly Soluble Compounds

• SEDDS formulation
• Nanosuspension (wet media milling)
• Emulsion, microemulsion, lipid based complex and micelle formulation
• Solid Dispersions: micro-crystalline or amorphous form with carrier matrix
• Solubilizing Agents: cyclodextrins, surfactants, polar organic solvents

Early Phase Clinical Formulation

• Powder in Capsule (PIC)
• Powder in Bottle (PIB)
• Tablet
• Liquid formulation

Oral Solid Technologies

• Wet granulation (high shear, fluid bed, extrusion spheronization)
• Dry granulation (roller compaction)
• Nanosizing in solid dosage form
• Tabletting, hard shell and soft-gel capsulation
• 0.1-20 kg capacity (for SFDA studies and FDA studies)

Injectable Formulation Technologies

• Sterile fill-finish (terminal sterilization, filtration and sterile filling)
• Lyophilization (Lyostar II with SMART technology, and in-process sample extractor)
• Nanosizing technologies (Microfluidizer and Dyno-mill)