Solid state chemistry is fundamental to the development of a pharmaceutical compound into a drug product, and understanding analytics is crucial to successfully addressing any challenges that can occur in a product’s lifecycle. In solid state chemistry specifically, the physical and chemical (PhysChem) analytics will show which properties need to be improved to help ensure the highest chances of success: purity, stability, solubility, or bioavailability.
In drug development, knowing the characteristics of each form of the active pharmaceutical ingredient (API) is essential in order to select the most suitable form for production. For the research chemist, the PhysChem purity is one of the most crucial requirements. Furthermore, selection of the thermodynamically most stable polymorph; low hygroscopicity measured by dynamic vapor sorption (DVS); consistent crystallinity measured using X-ray powder diffraction (XRPD); sharp single melting event determined by differential scanning calorimetry (DSC); and low levels of residual solvent by thermogravimetric analysis (TGA) are all part of the ranking criteria. Aqueous solubility and dissolution rate are indispensable for the route of delivery and dosage form.
The Alcami Advantage
- Controlled development experiments and uniform, scalable production conditions will result in consistent purity, stability, solubility, and bioavailability.
- The analytical database generated as part of this work will provide a historical overview of the specific properties of the drug substance.
- Early full characterization of the API will map out the properties to improve, add more value to the compound, and ease the API manufacturing and formulation processes.
Alcami’s Center of Excellence (CoE) for solid state chemistry and crystallization is located in our Weert, Netherlands facility. The CoE provides multiple services to support the selection of the preferred developable compound form, including crystallization, analytics, form selection screening, process design of experiment (DoE), particle habit engineering, and preformulation. Alcami also operates a CoE for API development, scale up, and commercialization in Germantown, Wisconsin. By employing a strong collaborative approach between client, process engineer, and Alcami’s CoEs, the most optimal compound form is selected for meeting a customer’s unique needs and timelines.
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Edwin Aret, PhD
Edwin Aret holds a PhD in solid state chemistry from Radboud University Nijmegen, the Netherlands. He has nearly 20 years of experience supporting every facet of the pharmaceutical development cycle, from discovery to commercialization, covering small molecules, drug substance, and drug product. Edwin’s in-depth expertise includes crystallization, form selection, stability studies, solubility determination, bioavailability, and crystal habit optimization. Edwin is currently the principal scientist for solid state chemistry at Alcami.
Bianca van Bree, PhD
Bianca van Bree earned her PhD in biomedical sciences from Maastricht University, the Netherlands. She has over six years of experience in the pharmaceutical development industry. She started her career as a molecular biology research and development scientist, and advanced into project management. Her expertise is in managing pharmaceutical ingredients and biomedical device projects from research phase to early phase clinical trials. Bianca joined Alcami in 2018 as a project manager.
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