Determination Of The Roundness Of Globules In The Pharmaceutical Industry

The determination of grain size and roundness of globules and other vehicles in the pharmaceutical industry is of special interest. This is because the active substance content of the finished globules and functional drugs correlates with their grain size or layer thickness. In addition, the shape of the globules is one of the deciding factors for further usability, for example in dosing dispensers. For controlling these quality characteristics quick, objective measurement methods are required which guarantee high analytical accuracy as well as a high product throughput.

Small round particles (globules) are widely used as a delivery device for medicinally active substances. Saccharose is often used as the base substance. The sugar crystals are formed into globules by means of a complicated building-up process. Alcoholic solutions of the specified active components are then used to introduce the material into the finished globules by absorption.

Globules are manufactured to size specifications according to their uses, covering a certain grain size range. Testing of whether the globules correspond to this grain size range is still usually carried out by means of sieve analyses.

Apart from the grain size, the grain shape is also important for further use of the globules. Convenient dosages for the user, for example from dispensers, require particles which are as round as possible, since globules which deviate considerably from a spherical shape may get stuck or be destroyed by the dosing mechanism.

A fast, objective measurement method for characterizing size and shape to eliminate systematic errors is required to improve throughput and statistical validity.