Preformulation Support Services
Partner with Natoli Scientific during the earliest stages. Our scientific expertise with state-of-the-art analytical capabilities is ready to take any preformulation challenge.
Natoli scientific has an expertise of handling a wide range of APIs for the development of oral solids. We apply principles of ‘Quality by Design’ to define Critical Material Attributes (CMA), Critical Process Parameters (CPP), Critical Quality Attributes (CQA) and Quality Target Product Profiles (QTPP). Because we believe that understanding material and process as much as possible in the early life cycle of drug product development program is an insurance for further development path. Keeping your practices up to date with the ICHQ8 regulatory guidance issued by the US FDA. This is also a gate way for a smooth ride of product in the different stages of product development stages.
We offer Design of Experiments (DoE) studies for a smart experimentation to capture maximum information with minimum laboratory efforts. We do offer discrete studies if necessary. This keeps low study cost for our customers, as we believe that saving is earning.
Our advanced on- and off-site material analytical suites provide raw material characterization, basic powder flow characterization, advanced powder flow characterization, compaction performance testing with Compaction Simulation and Emulation with Presster, Powder Density Testing, as well as other tablet quality control testing like Tablet Friability, Tablet Disintegration, and Tablet Dissolution.
When it comes to preformulation needs of solid dosage forms, Natoli Scientific is a natural choice to ensure your product meets its QTPP.
Preformulation Support:
- Raw Material Characterization
- Physical Characterization – PXRD, DSC/TGA, PSD
- Powder Flow Characterization
- Compaction Emulation/Simulation
- Density Testing
- Other Tablet Quality Control Testing
- Tablet Friability
- Tablet Disintegration
- Tablet Dissolution
- Stability testing
- Informal stability studies
- Forced degradation studies
- Accelerated stability studies
- Beyond use or expiration date
- Excipient compatibility testing
