Současné metody měření velikosti částic farmaceutických látek a jejich omezení

Abstrakt

The particle size and shape of raw materials influence the manufacture and behavior of solid dosage forms. The most widely used methods of particle size measurement are laser diffraction and image analysis. These methods are based on different principles and measurement ranges. Only the results obtained by the same method under the same conditions can be compared. Laser diffraction is significantly faster if a validated method is known. The method is defined for every raw material to guarantee reproducibility of measurement. Image analysis is inexpensive and does not require the validated method. Shape information is easily provided by image analysis. Laser diffraction is a suitable method for routine quality control. Image analysis is an optimal technique for development of pharmaceuticals.