ABSTRACT

The goal of pharmaceutical expansion is to produce a high-quality product and manufacturing process that consistently delivers the product's intended performance. During the design and development of a product in QbD, a company must define its desired product profile, identify the critical quality attributes, understand the impact of raw materials on the CQAs, and identify the control source of variability. Oral fast disintegrating films were developed in the QbD framework to understand and control the product and process with quality-based risk management, Fast dissolving oral thin films are useful in patients who have struggled to swallow tablets or hard gelatine capsules, such as children, the elderly, and the bedridden or developmentally disabled. Due to their advantages over other oral dosage forms, oral fast dissolving films are the most advanced form of the dosage form. This type of technology provides a convenient method of dosing medication not only for special population groups such as pediatric geriatric, bedridden, and mentally ill patients but also for general populations. The current review delivers an account of oral fast disintegrating films' formulation and product development through the implementation of QbD aspects such as QTPP, CMAs, CQAs risk assessment, and risk estimation matrix. Keywords: Quality by design, pharmaceutical development, QTPP, CQAs, risk estimation matrix, Ishikawa diagram
Publication date: 01/06/2023

https://ijbpas.com/pdf/2023/June/MS_IJBPAS_2023_7194.pdf

Download PDF
https://doi.org/10.31032/IJBPAS/2023/12.6.7194