Sugar Spheres used in the Pharmaceutical Industry

Many solid oral dosage forms are based upon coating sugar spheres with layers of active ingredient, binders, and coatings. These engineered granules are then either mixed with other excipients and compressed into tablets or loaded into a capsule. The size and shape of the beginning sugar spheres (also called nonpareil beads) are critical physical characteristics that should be carefully measured and controlled. Particle size has historically been performed using sieves, with specifications given based upon an upper and lower size cut. Most published specifications such as #30/35 implies that not less than 90% passes a 30 mesh sieve and no more than 10% passes a 35 mesh sieve.

While sieves are an acceptable technology for defining the size distribution of the sugar spheres, higher resolution techniques are required to monitor the thickness of coatings added to the surface. The CAMSIZER digital image analyzer has been successfully used to provide both particle size and shape data for coated sugar spheres. Papers published in the scientific literature* have discussed how the CAMSIZER has been used to replace sieves and quantify the shape of sugar spheres used in the pharmaceutical industry.

The image to the right show the ability of the CAMSIZER to quantify the difference in particle size between sugar sphere batches that respectively experienced a 13 and 15% weight gain as they were coated with active ingredient.

The simultaneous measurement of both size and shape allows the CAMSIZER to report information about coating thickness, sphericity, broken particulates, particle count, and surface-to-volume and surface-to-mass ratios. The CAMSIZER may be used as a research, diagnostic and quality control tool for sugar spheres and other mulit-particulates/granules.  That’s unprecedented value which other technologies just cannot match.

For additional information on this subject please follow the links below:

Webinar by Grant Heinicke - Dynamic Image Analysis of Granules.

Webinar by Gert Beckmann - An Introduction to the CAMSIZER Dynamic Image Analyzer.

Download the Application Note AN142 Determination of the Roundness of Globules in the Pharmaceutical Industry (You need to be logged in).

Download the Application Note AN177 Particle Size and Shape Analysis of Pharmaceutical Granules (You need to be logged in).

*Click the link below for a summary on the use of sugar spheres in the pharmaceutical industry published in Pharmaceutical Technology Europe
Werner, D, Sugar spheres: a versatile excipient for oral pellet medications with modified release kinetics, Pharm tech Europe, April, 2006.

*Click the link below to download (fee required) the article by Heinicke et. al. on using the CAMSIZER to measure coating thickness of sugar spheres:
G. Heinicke, F. Matthews, and J. B. Schwartz, The Effects of Substrate Size, Surface Area, and Density on Coat Thickness of Multi-Particulate Dosage Forms, Pharmaceutical Development and Technology, 1:85–96, 2005.

*Papers published in the scientific literature bibliography section of this website.