Comparing deep freezing, flash freezing and annealing induced materialistic changes during the formulation of alanine and serine monomers mediated fast disintegrating tablets

Abstract

Despite significant advancements in the formulation of lyophilized fast disintegrating tablets (FDTs), saccharides and polyols remain ubiquitous matrix support agents and disintegration enhancers. This also impeded the use of FDTs in the treatment of chronic disorders wherein sugar intake is restricted to the patients. The present work utilizes the combination of alanine and serine as amino acid material to prepare zero saccharide/polyols FDTs. For the formulation of FDTs, we uniquely employed three different techniques namely, deep freezing, flash freezing and annealing and evaluated the impact of these processes on sublimation rate (thermal modelling), crystallization tendencies and different FDTs properties such as hardness, fracturability, disintegration time (DT), porosity, % weight variation, friability, lyophilization index etc. The findings demonstrated that, in comparison to their individual counterparts, the addition of alanine and serine at optimized ratio could improve the powder characteristics and thereby FDTs characteristics. Annealing also sped up the sublimation process and decreased the amount of time it took for the FDTs to disintegrate. Moreover, it has been found that the tableting properties, including DT, friability, and % weight variation, were under compliance with the United States pharmacopeial (USP) standards, indicating the acceptability of the developed FDTs to the pharmaceutical industries.