Formulation Development

CDRI develops pharmaceutical formulations across all phases of clinical development, ranging from preclinical to late-stage trials.

Preformulation Studies

- Definition of target product profile

- Physicochemical property characterization

- Compatibility studies between APIs and excipients

- Solubility enhancement and bioavailability improvement

Formulation and Process Development

- Development of solutions, suspensions, tablets, and capsules

- Application of direct compression, encapsulation, dry/wet granulation techniques

- Modified-release dosage forms (e.g., matrix tablets, enteric coatings, multiparticulates)

- Process optimization utilizing Quality by Design (QbD) and Design of Experiments (DoE) principles

Analytical development

- Method development and validation

- Stability studies and determination of shelf-life

Technology transfer

- Production scale-up

- Technology transfer to external laboratories and manufacturing facilities