Formulation by Design: An Overview

Author:

Das Ushasi,Kumar Panda Dilip,Mandal Sanchita

Abstract

Quality is the most important and necessary attribute for pharmaceutical product development, and it has become the focus of regulatory bodies in order to approve safe, efficacious, stable, patient-compliance, and cost-effective drug delivery systems. QbD-based formulation development is discovered to be an immerging technique in this context. FbD is a formulation development concept that aims to create more effective, safe, robust, cost-effective, and patient-compliant drug delivery systems. This chapter will provide an overview of Formulation by Design (FbD), different terminologies, design of experiment (DoE) and quality by design (QbD), types of experimental design, QbD applications, and FbD methodology along with benefits.

Publisher

IntechOpen

Reference85 articles.

1. Fukuda I, Pinto C, Moreira C, Saviano A, Lourenço F. Design of Experiments (DoE) applied to pharmaceutical and analytical quality by design (QbD). Brazilian. Journal of Pharmaceutical Sciences. 2018:54(spe). DOI: 10.1590/s2175-97902018000001006

2. Singh B. QbD in pharma product development life cycle. Chronicle Pharma Biz. 2013:72-79

3. ICH, Pharmaceutical development Q8(R2), International Conference on Harmonisation, IFPMA, Geneva (Switzerland), 2009 [Accessed on August 3, 2022]

4. https://www.ema.europa.eu/en/human-regulatory/research-development/quality-design [Accessed: August 3, 2022]

5. Kovács B, Péterfi O, Kovács-Deák B, Székely-Szentmiklósi I, Fülöp I, Bába L, et al. Quality-by-design in pharmaceutical development: From current perspectives to practical applications. Acta Pharmaceutica. 2021;71(4):497-526. DOI: 10.2478/acph-2021-0039

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