Thermal degradation of gelatin as applied to processing of gel mass.

The rheological parameters of rigidity and viscosity were studied for gelatin, both as a 6% solution and a 38% gel mass containing glycerin, sorbitol, and water. A compressive test for rigidity and a rotational shear method for viscosity were used to characterize the thermal degradation of several lots of alkali-processed calf-skin gelatin. The objective of this study was to use kinetic data for process predictions in the manufacturing of the gel mass for soft gelatin capsules. Empirical equations relating degradation to time, temperature and pH were derived for dilute gelatin solutions. Through parallel studies with a concentrated gel mass, other empirical equations were developed to predict degradation of the gel mass based on dilute solution data and processing conditions. Analysis of the kinetic data and empirical equations have generally confirmed earlier observations on degradation, except on quantitative aspects. While these equations are adequate for the intended use in process predictions, the study revealed substantial variability both within and among lots of commercial gelatin. These variabilities of uncertain causes contributed to inexact characterization of degradation, as demonstrated by the generally approximate results of process predictions.