Metrics scientists may suggest an excipient compatibility study to determine which inactive ingredients are best suited to meet the dosage form requirements to support a Phase II (or III) project. The relative amounts of inactive ingredients in relation to the API will be evaluated to identify a suitable drug product formulation.
The inactive ingredients will be selected based on the properties desired for the drug product, either as immediate, modified or controlled release dosage forms.
Our expert scientists and experienced operators will recommend studies to determine which process is most suitable for the drug product.
We evaluate the use of techniques that include:
The selected manufacturing process will be evaluated using a Design of Experiment or an experimental batch. Proactive problem solvers first and foremost, our team will troubleshoot and optimize your process efficiently.
Throughout Phase II and Phase III, Metrics considers your scale-up and commercialization requirements. We offer various sized equipment to accommodate each phase and enable efficient scale-up which conform to SUPAC requirements. Clinical Trial Material batch sizes from 100g to 450kg.
At Metrics, we promise a collaborative partnership offering guidance throughout your program.