Solid State chemistry
The solid-state chemistry of an active pharmaceutical ingredient (API) is a fundamental aspect to be considered in the Final Dosage Form (FDF), in particular with respect to the morphology, crystalline form and the particle size distribution, as it can dramatically affect bioavailability.
The experts at the Axplora Solid State Center of Excellence support specific customer requests regarding the physical properties of their products.
Expertise in solid state chemistry
With more than ten years of experience in solid state chemistry and characterization of physical properties of API, Axplora is an expert in the field.
Davide Bordone, Responsible for the Solid State Center of Excellence:
“The Axplora Solid State Center of Excellence brings together a passionate team focused on satisfying the customer request by evaluating the latest innovative techniques.”
Our solid state services for APIs
Axplora offers a broad range of services regarding Solid State chemistry:
- Screening of crystalline forms
- Identification of the best polymorph or of a new polymorph to be developed
- Screening and identification of new polymorphs to circumvent patent constraints and arrive earlier to the market
- Co-crystal screening, selection, and crystallization development
- Process development
- Development of a scalable procedure for the selected crystalline form
- Proven Acceptable Ranges (PAR) study of crystallization parameters
- Quality by Design approach (DOE)
- Characterization of the crystalline forms
- XRPD, DSC, Morphology, Particle Size Distribution (PSD), Tapped Density, Bulk Density, NMR*, Single crystal X-Ray*
- Definition of the best milling technique to meet PSD requirements
- Support milling units to achieve the desired PSD in a robust manner
*External collaboration
State-of-the-art equipment for solid state chemistry
Equipped with state-of-the-art instruments, our solid state laboratory will support the development of your API:
- Differential Scanning Calorimeter (DSC): used to study the thermal events of the products & for characterization and investigation of transition of forms, transition of polymorphs and amorphous investigation,
- Automated Optical Microscopy (Morphologi4): used to automatically determine PSD distribution by volume or number of the particles, evaluate morphology and crystal shape,
- X-Ray Powder Diffraction (XRPD): an instrument for polymorph screening and characterization of products,
- Crystal 16: fast solvent screening equipment for crystallization and solubility curve determination,
- Easy Viewer for crystallization development: tool based on a high-resolution microscope allowing image analysis and measurement of particles in real-time,
- Turbidimeter: online measurement probe from laboratory up to production scale.
Our center of excellence for solid state chemistry
Our Gropello Cairoli site in Italy is Axplora’s center of excellence for solid state chemistry.
Discover our CDMO services and technologies for APIs:
