Preformulation and formulation scientists of our team work together with the medicinal chemistry, analytical sciences and drug substance process development groups to fully understand the physicochemical properties and also to select suitable salts. The core preformulation team supports discovery research and performs extensive material characterization.
Discovery support:
- Solubility in pH buffers (pH-solubility profile)
- Solubility in pharmaceutically useful solvents
- Drug solubilizer screening
- Determination of partition coefficients
- Solution/formulation stability
Material characterization:
- Salt and polymorph screening – CRISSY
- Morphology study (XRPD and HSM)
- Hygroscopicity evaluation - DVS
- Thermal characterization – DSC and TGA
- Particle size and size distribution
- Solid state stability
- Photo stability
- Degradation studies
- Drug - excipients compatibility studies
- Powder density, flowability & compressibility
Our formulation scientists have expertise in the solubilization of insoluble and low permeable compounds to increase the exposure/bioavailability. Our rich experience in preclinical formulation includes
Early preclinical formulation:
- Co-solvent technique
- Lipid base formulation
- Spray drying
- Complexation
- Nanosuspension
- SEDDS & SMEDDS
At each stage of drug discovery, formulation scientists develop the necessary dosage forms depending upon the study requirement and route of administration, ensuring the consistency, purity and stability of the drug product.
Our rapid formulation strategies such as drug in capsule (DIC), drug in bottle (DIP), blend in capsules and conventional solid dosage forms for first in human (FIH) help shrink developmental timeline. Our proficiency includes all cutting edge technology to overcome challenges of solubility and bioavailability in drug development.
- Solid solution
- Spray drying
- Self emulsifying drug delivery system (SEDDS)
- Micro-precipitation
- Complexation
- Modified release formulation
- Fixed dose combination
Clinical Support:
- Development of Clinical Formulation
- Development of placebo or comparator
- GMP manufacture of drug product
- Clinical Packaging & Labeling
- Double blind encapsulation/ randomization packaging