Early-Phase Oral Solid Dose 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. Solubility is one of the key attributes of a drug candidate and one of the biggest challenges in drug development. Approximately 70-90% of New Molecular Entities (NMEs) in today’s drug pipeline are poorly soluble, which complicates delivery and results in poor bioavailability. The majority of these NMEs are DCS Class IIa / IIb and IV, which exhibit low bioavailability due to solubility-limited (IIb) absorption, dissolution rate-limited (IIa) absorption, or permeability limitations (IV). Bioavailability enhancement capabilities are available for addressing formulations containing solubility- or permeability-challenged APIs. We have enabling technologies that can solve solubility-induced absorption issues as well as access to a Lipids Excipient portfolio for SEDDS / SMEDDS, Nanocrystals, and Liposomal formulations that can resolve permeability issues.