Solid-State Characterization Services
PROVIDING THE MOST STABLE CRYSTALLINE FORM
A Partner with Expertise
Since 1991, Catalent’s small molecule analytical team has developed and applied thousands of analytical methods to help customers progress their drug candidates. Our solid-state characterization projects are managed through our North American facility in Morrisville, North Carolina, and leverage Catalent’s network of over 3,000 scientists and technicians, combining the benefits of a focused, single-site solution, with the scientific resources of a multi-disciplined product development and research network.
Each solid-state form of an API has unique physicochemical properties, which can have a profound impact on a finished product’s bioavailability, stability, and manufacturability. By discovering and characterizing the diversity of solid-state forms, it becomes possible to select an optimal form that displays an appropriate balance of properties that are critical for successful preclinical evaluation and product development, as well as robust manufacturing processes.
KEY CAPABILITIES
- Physical Characterization and Preformulation Packages – Includes PXRD, DSC/TGA, TGA-IR, FT-Raman, FT-IR (ATR), UV-Visible spectroscopy, hygroscopicity analysis, gross purity by HPLC, kinetic solubility in biorelevant media, pH solubility, intrinsic dissolution rate, logP/logD determination. Short term solid state and solution state stability, bulk/tap density. Various ad. hoc. testing provided, including quantitative methods for crystal form analysis
- Crystal Form Screens – Designed to discover polymorphs and solvates (including hydrates) and determine suitable developable forms and the most thermodynamically stable form. Selected forms may be scaled up for further studies (preformulation developability, stability)
- Comprehensive Crystal Form Screens – Increased number of experiments over conventional crystal form screens to address process risk and over intellectual property of late stage assess (post Phase 2)
- Crystallization Process Development – Designed to probe the practical, reproducible, and robust, process conditions for the desired crystal form
- Crystallization Screens – Designed to crystallize amorphous drug substances, which may be further investigated with crystal form screens
- Salt Screens – Designed to screen for potentially suitable salts to improve physical properties, solubility, or stability of the drug substance. Selected salts may be scaled up for further studies (preformulation developability, stability)
- Co-crystal Screens – Designed to discover co-crystals composed of drug substance and pharmaceutically acceptable cocrystal formers, to improve properties of the drug substance by increasing solubility, improving stability etc.
KEY INSTRUMENTATION
- HPLC – UV, DAD, IC
- PXRD with variable temperature accessory
- Single Crystal X-ray Diffraction (through a third-party partner)
- PLM with hot stage accessory
- Visual Melting Point apparatus with camera
- SEM
- FT-Raman and FT-IR (ATR)
- DSC, TGA, TGA-IR (IR allows identification of evolved gases from TGA)
- Gravimetric Vapor Sorption (Dynamic Vapor Sorption)
- NMR (for purity evaluation and salt and cocrystal stoichiometry)
- Laser Diffraction (for particle size analysis)
- Image Analyzer (for particle size analysis)
- Vacuum centrifuge
- Others (Lyophilizers, fiber optic dissolution, stability chambers etc.)
ADDITIONAL INSTRUMENTATION
- Lyophilizers
- Jacketed Reactor (up to 2 L)
- Pion µDiss fiber optic dissolution system
- Suntest CPS+ Light Chamber
- GMP Stability Chambers
- Bespoke and off the shelf equipment for handling and processing powders
- Retsch® Ball Mill and Cryo Mill
- Misc. lab equipment such as rotary evaporator, pH meter, osmometer, viscometers, J-Kem temperature-controlled heating blocks, custom heat/cool apparatus, vacuum ovens etc.
WHY CATALENT
Accelerated Approach high throughput API screening platform that will help accelerate your development and optimization of drug molecules.
Expertise highly skilled Ph.D. Scientists with experience characterizing over 1000 compounds spanning from early-stage lead compounds through launched products.
Complete Suite of Analytical Services from early preclinical through clinical and commercial stages, Catalent delivers a single-provider solution for all your analytical needs.