Pankaj Doshi, Worldwide Research and Development, Pfizer Inc.
The optimization of lubrication in pharmaceutical solid dosage manufacturing is important for ensuring tablet quality and process efficiency. Lubrication improves flowability, prevents sticking to compression tooling and ensures smooth tablet ejection, but must be precisely controlled because excessive lubrication can also negatively impact critical tablet quality attributes. Specifically, it can decrease tablet strength, decrease wettability, and/or change the dissolution profile of the tablets. Measuring and controlling the susceptibility of a formulation blend to over-lubrication typically involves producing and testing tablets subjected to different levels of lubrication, which is time and resource-intensive. Though empirical models help streamline this process, they lack specificity to the excipient blend formulation and do not account for the impact of the active pharmaceutical ingredient on over-lubrication. Therefore, it is necessary to develop a simple tool to efficiently assess the susceptibility of blends to over-lubrication without the need for producing multiple tablets and conducting extensive testing.
We aim to develop a science of scale tool for rapid assessment of the extent of lubrication. Our approach observes changes in the powder physical properties with varying amounts of lubricant and extent of mixing. By linking these measurements to tablet quality attributes such as tensile strength, we aim to develop a method for monitoring and controlling the extent of lubrication. This tool provides us with a real-time assessment of powder lubrication and ensures consistent product quality in pharmaceutical manufacturing.
