Validation of particle size distribution in pharmaceutical excipients | Abstract
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Annals of Biological Research


Validation of particle size distribution in pharmaceutical excipients

Author(s): N. Kanaka. D. Devi, N. Narasimha Rao, M. Anuradha1, P. Naveena, P. Sravani., Y. Satyasesha Sree

Particle size distribution is a critical feature of the drug development process. It influences manufacturability, pharmaceutical elegance product performance and formulation. The particle size distribution of a pharmaceutical ingredient or product is often described by a log-normal distribution from which a single representative number, such as mean or median particle size is usually derived and reported. The aim of the study was to elucidate a correlation between the quantitative statistical micromeretic parameters of pharmaceutical powders in order to validate the particle size distribution. Pharmaceutical powders are quantized by coefficient of skewness (IQCS) and coefficient of kurtosis (β2) determination and the correlation between the two statistical parameters was assessed. The third and fourth moments, descriptors of skewness and kurtosis, may be used to test the hypothesis that the sample came from a normal distribution.  Particle size analyses of the powders were carried out by microscopic technique using  eye piece micrometer. Around 600 particles were counted avoiding the aggregates and the data obtained was plotted as frequency distribution curve and cumulative frequency distribution curve. All the powders showed asymmetric particle size distribution as their IQCS values were observed .