Identify Physicochemical Properties During Preformulation
Achieve a rational and streamlined pharmaceutical preformulation process by understanding the physicochemical properties of your compound. Our team’s physicochemical characterization testing helps you make informed decisions about drug substance selection, and achieve effective process development and manufacturing design of both drug substance and drug product.
Our approach to understanding physicochemical properties includes starting material characterization for solid state characteristics and potential developability. We work to discover other developable solid forms to provide insights for molecule preformulation.
Starting Material Profiling
Starting materials need to be optimized for formulation development. Our team develops various iterations of the solid form by modifying chemical architecture through alternative crystallization routes provides a mechanism to enhance characteristics such as water solubility, manufacturing and storage stability, and bioavailability.
Profiling starting materials is essential to identifying lead candidates. Since our molecular understanding is limited at this stage, our team generates materials to facilitate safety and efficacy studies, showcasing their physicochemical characteristics. These formulations are essential for toxicology screening and help identify potential issues to the compound’s development.
Once your starting material profile is established, its potential developability is evaluated based on three key criteria. First, we gauge the material reproducibility and scalability during early manufacturing. Then, we predict how it will behave under storage conditions based on its chemical and physical stability. Finally, we assess the material’s administration potential based on its solubility and bioavailability.
Your starting materials may display undesirable attributes that require alternative solid-state forms for development. Our team performs crystallization screening (free form, salt form, cocrystal) to determine the best design process for optimizing your material’s qualities.
Understanding Polymorphism to De-Risk Drug Development
Polymorphism in drug development is used to characterize the different crystalline phases of a molecule, which then informs selection of a solid form for further development. Each polymorph may vary in drug dissolution and solubilization resulting in assorted rates of bioavailability in the body. Tune into the on-demand webinar to explore the concept of polymorphism, the techniques used to discover polymorphs, and how to apply them to your drug development strategy.
Molecule Preformulation
After formulating the API, excipients play a crucial role in improving the practicality of the optimized solid forms by enhancing properties like wettability and flowability, facilitating their effective integration into the body’s systems. Our team helps address incompatible physical behaviors to aid a smooth transition through downstream development and successful manufacturing processes.
A high proportion of experimental drugs have low aqueous solubility, which creates formulation challenges due to poor dissolution, low and variable bioavailability, and potential food effects in oral formulations. Our strategy addresses such multifaceted solubility issues to achieve your compounds necessary solubility for improved exposure, thereby avoiding undesirable PK profiles and efficacy issues.
For orally administered drugs, achieving meaningful exposure relies not only on solubility but also on permeability. The FDA's Biopharmaceutics Classification System (BCS) provides guidance, categorizing drugs from Class I to IV based on characteristics that affect their development pathway. As a compound's classification moves from I to IV, it becomes progressively less soluble, less permeable, and more challenging to deliver effectively. Our expert team is well-versed in the nuances of each BCS class, enabling us to formulate with precision and address the unique benefits and challenges of each classification.
Your drug substance and drug product’s chemical and physical stability are paramount to its success. We evaluate environmental influences, degradation pathways, and surface-solvent reactions to help you forecast potential challenges later in development. We employ multiple approaches to characterize drug stability, including pH solubility, solid-state stability and pH Chemical Stability profile.
Excipients are essential to optimize your compound’s performance. Our team conducts a broad excipient compatibility screen during preformulation to identify optimal excipients and define boundary conditions for formulation screening. In turn, fewer formulations are subsequently examined which saves considerable resources.
Integrated Laboratory Services
When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts can add power to your project.