CordenPharma's OSD Drug Product Innovation Centre of Excellence

CordenPharma’s Drug Product Innovation Centre of Excellence offers early phase formulation development and manufacturing services for Oral Solid Dose (OSD) drug products, including Bioavailability Enhancement technologies. In collaboration with our Solid State Centre of Excellence, we provide integrated API and drug product services, ensuring a continuous feedback loop between identifying the best API form required for a drug product formulation that provides sufficient absorption / solubility, stability, and processability. First-in-Human (FIH) OSD Capabilities Getting a product into FIH clinical Phase I studies in a flexible, fast, and efficient manner is important. CordenPharma offers an initial developability assessment that includes API profiling and technology selection (conventional, bioavailability enhancing) followed by a screening study (excipients, polymers, etc.), phase-appropriate formulation development, and prototype preparation. Utilizing the Accelerated Stability Assessment Program (ASAP) for stability, CordenPharma is able to identify the best prototype to manufacture and advance into FIH quickly. Early Phase FIH Capabilities - Integrated DS and DP Development - Developability Assessment - Screening Studies - Formulation Challenges - GLP Supply - FIH Supply - ASAP and Accelerated Stability Programs - Analytical Support Bioavailability Enhancement As a part of CordenPharma’s Early Phase Drug Product Innovation Centre of Excellence, bioavailability enhancement capabilities are available for addressing formulations containing solubility- or permeability-challenged APIs. In addition, we have enabling technologies that can solve solubility-induced absorption issues as well as access to a portfolio of Lipids Excipients for SEDDS / SMEDDS, Nanocrystals, and Liposomal formulations that can resolve permeability issues.