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The average diameter and size distribution of particles in commercially available isophane-insulin and zinc-insulin aqueous suspensions (11 products) were examined using laser-light diffraction spectroscopy (LLDS). Wide variation was observed between products in volume-weighted and number-weighted average diameters. The particles in the insulin aqueous suspensions were found to be mono-dispersed within relatively narrow size distributions. Sonication for a short time led to a downshift in the apparent average diameter, which was most remarkable with isophane-insulin aqueous suspensions. This could be ascribed to dispersion of aggregated needle-like crystals and/or crystal breakage. In the case of biphasic isophane-insulin aqueous suspensions, the average size as well as the size distribution shifted toward the smaller end of the scale with decrease in the isophane content.

chemical and pharmaceutical bulletin/chemical and pharmaceutical bulletin

Estimations of Average Particle Sizes and Size Distributions of Commercially Available Human-Insulin Aqueous Suspensions Using Laser-Light Diffraction Spectroscopy.