Formulation Strategies for Pharmaceutical Development
The formulation strategy is the result of a thorough analysis of the preformulation data report, the intended manufacturing process, any patient compliance issues and any strategic and regulatory goals of the company.
Comprehensive evaluation of drug candidates during pre-formulation is critical to the formulation development process. Certain candidates present specific challenges such as low bioavailability, poor solubility and/or permeability, and poor physical stability. Formulation development can be helpful in overcoming many of these issues. Our approach includes:
- Pre-Formulation Solubility and Stability Evaluations
- Comprehensive Excipient Screening and Vendor Qualification
- Prototype Development
- Formulation Optimization and Finalization
- Identified Specification
- Supporting Documentation and Data Package in CTD/eCTD format meeting QoSrRequirements.