FEASIBILITY AND PROCESS OPTIMIZATION TRIALS FOR PREPARATION OF MINI-TABLETS OF ESOMEPRAZOLE BY DIRECT COMPRESSION TECHNIQUE Authors: Patel SK , PATEL AP AND PATEL JK
ABSTRACT
In recent years the prominence of mini-tablets dosage forms continuously increasing. Minitablets are tiny solid oral dosage forms having diameters ? 3mm. They are like subunits of
conventional tablets with same manufacturing process but only alteration is application of multitips tooling. These are patient friendly drug delivery system for patients having swallowing
difficulties along with lesser inter-intra individual variability and reduced dose dumping risk.
Simplicity and reproducibility of direct compression technique gives uniformity in dosage units
compare to conventional granules and pellets manufacturing. The objective of this study is to
evaluate feasibility by simple and easy direct compression process as well as process
optimization of esomeprazole mini-tablets manufacturing with respect to different levels of drug
loading, selection of excipients based on their particle size, particle size distribution and flow
characteristics along with modification in conventional excipient addition steps.
Keywords: Multi-tips tooling, Dose flexibility, Drug loading optimization, Excipient
selection, Particle size distribution, Reproducibility Publication date: 01/07/2022 https://ijbpas.com/pdf/2022/July/MS_IJBPAS_2022_6250.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2022/11.7.6250