Crystallization
Unless there is a strong biopharmaceutical driver for the amorphous phase, for instance high solubility or fast dissolution, the crystalline state is with no doubt the preferred form. However, there are many challenges that come with crystallization. Compounds can refuse to crystallize and we must then identify conditions that allow crystallisation despite previous efforts. Crystallisation development and scale-up is always a challenge since the product properties must meet up to the intended functionality, stability and safety of the final product.
The properties of a crystalline compound are significantly different from that of an amorphous one and it is vital to perform also the early phase investigation on the representative form in order to avoid serious misinterpretations. The actual crystallization process is however far from trivial and many new compounds are difficult to control when synthesized.
API solid form
Our team of experts are highly experienced in supporting well-designed crystallization processes and supporting your development by providing deeper insight into the solid-state properties of your drug substance helping you to ensure high product purity and the consistent delivery of the desired crystal modification.
Since the particle size distribution of the product depends upon both the solvent/solute system used and process parameters and equipment properties, crystallization can be employed to engineer particles precisely and with the right properties that ensure the optimum performance of the drug product. By applying our practical know how, theoretical understanding and innovative technical approaches we provide direct support in this area. Integrated into our small scale approach is not only traditional solvent based methodology but we perform also complementary investigations, based on alternative technologies, and thus significantly increase the success rate of providing you with seeds or a manufacturing protocol.
Capabilities
- DSC / MDSC
- TGA
- XRPD
- IR (microscopy possibility)
- Raman (microscopy) LALLS (Malvern 3000, Malvern Mastersizer)
- BET
- Powder flow
- Pycnometer
- GVS
- TAM (microcalorimetry) Isothermal or Scanning
- SEM
- EDS-SEM
- LM
- NMR
- SXRD
- Reverse engineering
- Micronisation
- Micro mixing
- Crystallinity
- Amorphicity
- Salt & polymorph screening and selection
- Crystallisation of “difficult-to-crystallise” compounds
In addition to the above list, Magle Chemoswed AB performs a broad range of tailor-made investigation services related to material characterization, understanding, troubleshooting and synthesis of gram and kilo quantities.
Talk to one of our specialists
Thomas Larsson
Thomas has 30 years of experience from working within global pharmaceutical industry. He is expert in solid state characterization of pharmaceutical APIs and formulations and is Solid State Manager within Magle Chemoswed AB since 2019.
