drug product suspensions), a specification is required when particle size is critical to any of the following: dissolution, solubility or bioavailability processability stability or product content uniformity. This guideline suggests that for both solid dosage forms and liquids containing undissolved active ingredients (i.e. ICH guideline Q6A provides a useful decision tree to help determine if a particle size specification is necessary. As a result, pharmaceutical manufacturers often seek to manipulate and control particle size, especially of the active ingredient (API). These correlations mean that particle size and particle size distribution are routinely identified as critical quality attributes (CQAs) – characteristics that have a defining influence on clinical efficacy. Particle size and particle size distribution are widely recognised as having a significant influence on the behaviour of pharmaceutical ingredients, from the solubility and bioavailability of an active through to the processability and stability of a finished blend. Paul Kippax, Product Group Manager, Malvern Instruments, and Chris Aiken, Laboratory Manager, Reading Scientific Services examine the physical sciences involved in developing and validating a laser diffraction particle sizing method for routine application in the laboratory
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