Comprehensive review on quality by design in fast dissolving tablets

Abstract

Fast-disintegrating tablets (FDT), also known as orally disintegrating tablets (ODT), are innovative oral dosage forms designed to quickly disintegrate in the mouth without the need for water, providing an effective solution for patients with swallowing difficulties, including pediatricians, geriatricians, and patients with dysphagia. It is preferred over traditional tablets due to its rapid disintegration, improved taste, and increased patient compliance. However, due to their fragile structure, high porosity, and sensitivity to humidity, FDTs require precise design strategies to ensure optimal performance, safety, and stability. Quality by Design (QbD), as described in the ICH guidelines, provides a systematic and scientific approach to developing reliable FDT formulations. QbD includes defining a quality target product profile (QTPP), defining critical quality attributes (CQAs), critical material attributes (CMAs), and critical process parameters (CPPs), and creating a design space to ensure consistent product quality. Through risk assessment and design of experiments (DoE), manufacturers can optimize formulation parameters such as superdisintegrants, binders, porosity, and compressive strength to achieve the desired balance between rapid disintegration and mechanical strength. Control strategies that include raw material evaluation, in-process monitoring, humidity control, and final product testing further improve product reliability. Case studies show that the QbD approach significantly improves the solubility, stability, and bioavailability of FDT. Overall, QbD enables efficient and cost-effective development of high-quality FDTs, ensuring compliance with regulatory requirements and improving patient outcomes.