Physical stability of pharmaceutical tablets: from mechanistic understanding to prediction of long-term stability

Rights statement
Awarding institution
  • University of Strathclyde
Date of award
  • 2022
Thesis identifier
  • T16329
Person Identifier (Local)
  • 201864064
Qualification Level
Qualification Name
Department, School or Faculty
  • Stability studies play a crucial role in the development of drug products, with the data collected being used to optimise formulation and manufacturing settings; determine the required packaging for the product; assign the retest date or shelf life; and contributing towards regulatory submissions. In this thesis, we consider the physical stability of pharmaceutical tablets, which focuses on physical tablet properties such as tensile strength, disintegration and dissolution performance. In the first instance, 16 different formulations of placebo tablets were characterised to determine the tensile strength, porosity, initial contact angle, and disintegration time. A simple workflow is proposed to classify the performance-controlling mechanism of tablets. These mechanisms include dissolution controlled, wettability controlled, and swelling controlled. Each of the 16 placebo formulations were then stored under 5 different accelerated temperature and humidity conditions for 2 and 4 weeks to investigate the changes in physical tablet properties. The correlations in disintegration time with temperature and humidity for each formulation are discussed in relation to the performance-controlling mechanisms. Finally, three of the formulations were selected (one for each performance-controlling mechanism) to manufacture tablets containing griseofulvin as a model drug. Tablets were manufactured with 30% wt. griseofulvin and the characterisation and stability studies were repeated, with the addition of dissolution studies. The change in dissolution performance of each formulation is discussed, and long-term stability predictions are made.
Advisor / supervisor
  • Khadra, Ibrahim
  • Markl, Daniel
Resource Type