ChemPartner’s 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 NMPA, US FDA, and European Union EMA clinical studies.
Preclinical Formulation Development
- IV/oral liquid formulations for PK, pharmacology, and non-GLP tox studies
- Integration with internal drug discovery capabilities in medicinal chemistry, 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
- Tableting, hard shell and soft-gel capsulation
- 0.1-20 kg capacity (for SFDA studies and FDA studies)