The concepts of particle engineering and dosage form design have become dominant themes in pharmaceutical manufacturing. The need for particle size con¬trol of pharmaceuticals is becom¬ing more important as the industry attempts to formulate active phar¬maceutical ingredients (API’s) with poor aqueous solubility, which constitutes up to 40% of new chemical entities. The fundamental issue with particle size analysis is the variety of equivalent particle diameters generated by different methods, which is largely ascribable to the particle shape and particle dispersion mechanism involved. Thus, to enable selection of the most appropriate or optimal sizing technique, cross-correlation between different techniques may be required.
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