Understanding the solid-state form of materials including both drug substance and excipients is important for appropriate development into acceptable pharmaceutical products. The solid-state form can affect various properties including density, hardness, optical and spectral properties, hygroscopicity, solubility, dissolution, and both physical and chemical stability. In addition, the type of formulation, production processing and ultimate drug behavior can be influenced by the solid form. Combined, these attributes can have a profound impact on drug absorption and ultimate disposition in the body. Therefore, it is critical to understand and monitor the solid-state properties of both drug substance and drug product during the entire development process: from preformulation, once the optimal solid form has been selected, during the manufacturing process, and throughout the product’s shelf-life. In addition, it is imperative that fast, simple, and accurate analytical methods be used to monitor any changes in form. Improved Pharma’s complete suite of appropriate solid-state characterization tools include: X-ray powder diffraction, thermal analysis (differential scanning calorimetry, thermogravimetric analysis), water determination/monitoring tools (Karl Fischer and dynamic vapor sorption), optical, hot-stage, and cold-stage microscopy, along with UV/VIS, IR, Raman and NMR spectroscopy.
Solid-state form studies may include evaluating:
The propensity to form polymorphs, hydrates or solvates
The ability to form salts and cocrystals
The most stable forms for further development
Stabilization of amorphous materials
The single crystal structure of a form for IP purposes
Multi-phase systems
Along with Dr. Stephen Byrn, the founder of SSCI, Improved Pharma’s highly skilled consortium of solid-state experts have numerous years of combined experience in this field. Our complementary skill sets along with suitable analytical characterization tools allow us to approach complex problems from different perspectives in order to provide the most promising outcome for new therapeutics entering the pharmaceutical arena.