GMP AMORPHICITY DETERMINATION BY GAS PERFUSION ISOTHERMAL MICRO CALORIMETRY
The requirement for understanding and demonstrating control of particle amorphicity is coming under increasing regulatory scrutiny.
This requirement particularly affects inhaled products that incorporate pharmaceutical actives that have been micronised. This is because micronisation has the potential to cause surface crystal defects, fractures and localised amorphicity arising from the high energy particle collisions. Understanding the levels of amorphicity is important because it can affect downstream processing, stability and ultimately product performance.
Several techniques are available for determining amorphicity but Gas Perfusion Isothermal Microcalorimetry is the most direct and sensitive measurement technique available. We can provide simple one-off sample analysis, method development, validation, routine release testing and stability analysis to study the ‘relaxation’ behaviour of comminuted materials as the amorphous regions re-crystallise over time.
MEETING REGULATORY REQUIREMENTS
We provide GMP-compliant Gas Perfusion Isothermal Calorimetry within our MHRA-certified UK laboratory. We know of no other laboratory that has established this equipment to cGMP standards.
The instrument, installed & qualified, is a TA Instruments TAM III, one of the most sensitive isothermal calorimeters available and is complemented by a wide range of our other analytical techniques to support pharmaceutical product development and materials characterisation.