New Method To Quantify Redispersion Potential Of Al Salts In Vaccines

The stability analyses of pharmaceutical products are traditionally accomplished by visual observation of samples stored at low (+4°C), ambient (+22°C) and high (+35 to +50°C) temperatures during up to several years, depending on the temperature. The subjectivity of these tests, which highly depend on the operator, and their lack of traceability lead to tedious and sometimes poor-quality results. The Turbiscan identifies and monitors destabilization phenomena (migration or particle size variation) in complex systems as it measures macroscopic parameters directly related to the concentration and the particle size of the system. The coupling of transmission and backscattering detectors permits the instrument to address native sample without modification either in a diluted or concentrated form. The system identifies the actual destabilization mechanism by determining which instability is taking place in the system and evaluates its intensity in an objective, reproducible and traceable way at speeds up to 200x faster than traditional visual observations.