Degradation Kinetics of Thiamine Hydrochloride in Directly Compressed Tablets II: Reliability of Accelerated Stability Testing for Evaluating Tablet Formulations

Abstract

Directly compressed thiamine hydrochloride tablets formulated with single or binary blend of vehicles were used in this investigation. The change in the physical characteristics of vitamin tablets stored under different relative humidity conditions was statistically assessed and scored by relative ranking. Although Emcompress is known to accelerate drug decomposition (1,2) the results obtained with tablets formulated with this vehicle alone or in combination with other vehicles failed to show that the use of this vehicle may give rise to any discernible changes in the physical characteristics of the tablets. Although formulations containing Celutab as the vehicle are chemically stable (2) the tablets compressed with this vehicle showed a high degree of change in physical characteristics. The results obtained in this study indicate that Avicel alone or a blend of Avicel with either Celutab or Anhydrous lactose are suitable vehicles for the manufacture of thiamine hydrochloride tablets of high stability characteristics.