A STUDY ON THE MANUFACTURABILITY OF HIGH DRUG LOAD MINITABLETS

Abstract

Minitablets are small tablets of typically 1–4 mm in diameter and may be developed as special monolithic or multiparticulate solid dosage forms with numerous therapeutic benefits. Many researchers have conducted studies on minitablets but few have performed in–depth research on the manufacturability of high drug load minitablets. The conversion of micronized drug particles, with poor powder flowability and high charging tendency, into high drug load minitablets is a complex and multifaceted process which remains relatively unexplored. The research gaps were addressed in this thesis by examining different pharmaceutical processing techniques, formulation variables, compaction conditions and tools. Good quality, high drug load minitablets could be prepared from a fine powder containing poorly compactable, elastic paracetamol crystals through the design of optimized diminutive granules. Further insights on the influence of superdisintegrants and multi-tip punches were achieved, providing strategies for high productivity of minitablets with the desired quality attributes.