Development of a Robust Control Strategy for Fixed-Dose Combination Bilayer Tablets with Integrated Quality by Design, Statistical, and Process Analytical Technology Approach

Development of a Robust Control Strategy for Fixed-Dose Combination Bilayer Tablets with Integrated Quality by Design, Statistical, and Process Analytical Technology Approach

Control strategy and quality by design (QbD) are widely used to develop pharmaceutical products and improve drug quality; however, studies on fixed-dose combination (FDC) bilayer tablets are limited. In this study, the bilayer tablet consisted of high-dose metformin HCl in a sustained-release layer...

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Bibliographic Details
Main Authors: Myung-Hee Chun, Ji Yeon Kim, Eun-Seok Park, Du Hyung Choi
Format: Article
Language:English
Published: MDPI AG 2021-09-01
Series:Pharmaceutics
Subjects:
fixed-dose combination drug
quality by design
manufacturing process
control strategy
multivariate analysis
process analytical technology
Online Access:https://www.mdpi.com/1999-4923/13/9/1443

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https://www.mdpi.com/1999-4923/13/9/1443

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