Pre-formulation services encompass several activities: the physico-chemical characterization of the API, the selection of the best crystalline forms for the fill and finished product and the stability profile of the material.
Thanks to an extensive toolbox of analytical services and a dedicated team of experts with decades of industrial experience, CARBOGEN AMCIS offers comprehensive pre-formulation services at the Hunzenschwil (Neuland), Switzerland site to support the design and development of dosage forms for pre-clinical and clinical use.
Our pre-formulation offerings include:
- Complete characterization and impurity profiling
- Analytical support for method development and validation
- Solid state and crystallization services for crystal form selection and salt screening
- ICH (International Conference on Harmonization) stability studies and stress tests for drug substances and drug products in our proprietary ICH stability chambers
- Feasibility and pilot studies for dispensing microdosing and particle size distribution for Drug In Capsule (DIC) and Drug In Bottle (DIB)
- Bioavailability studies: dissolution, disintegration testing and solubility testing (simulation in physiological conditions)
- Moisture analysis: Karl Fischer titration, moisture sorption (DVS) and water activity investigations
Our pre-formulation services are tailored to each specific molecule/project and are offered as stand-alone or integrated services in combination with our formulation and aseptic production services.
Highlights of key instrumentation:
- Semi-Automated Dosing Xcelolab from Capsugel
- Non-GMP Jet Mill and GMP Jet Mill (up to 50 grams)
- Water activity and moisture analysing instruments
- Dynamic vapour sorption system
- Dissolution testing equipment
- Disintegration testing equipment
- Powder, closed-loop weight dispenser
For more information about our integrated analytical, solid state and crystallization services, download our brochure on ICH stability studies.
