A workflow for column interchangeability in liquid chromatography using modeling software and quality-by-design principles

2017 ◽  
Vol 146 ◽  
pp. 220-225 ◽  
Author(s):  
Róbert Kormány ◽  
Katalin Tamás ◽  
Davy Guillarme ◽  
Szabolcs Fekete
Keyword(s):  
Liquid Chromatography ◽  
Quality By Design ◽  
Design Principles ◽  
Modeling Software

Determination of critical quality attributes for monoclonal antibodies using quality by design principles

Biologicals ◽  
2016 ◽  
Vol 44 (5) ◽  
pp. 291-305 ◽  
Author(s):  
Nadja Alt ◽  
Taylor Y. Zhang ◽  
Paul Motchnik ◽  
Ron Taticek ◽  
Valerie Quarmby ◽  
...  
Keyword(s):  
Monoclonal Antibodies ◽  
Quality By Design ◽  
Design Principles ◽  
Quality Attributes ◽  
Critical Quality Attributes

Implementation of Quality by Design principles for the evolution of optimized sustained release drug delivery system

2021 ◽  
Vol 11 ◽  
Author(s):  
Lalit Singh ◽  
Vijay Sharma
Keyword(s):  
Mathematical Model ◽  
Drug Delivery ◽  
Sustained Release ◽  
Drug Delivery System ◽  
Delivery System ◽  
Dosage Form ◽  
Quality By Design ◽  
Design Principles ◽  
Release Drug

Aim: Aim of the present work is implementation of Quality by Design principles for the evolution of optimized sustained release drug delivery system Background: Quality by Design (QbD) approach refers to an advance approach to develop a optimized dosage form.QbD has become a vital modern scientific approach to develop a quality dosage form.In modern era of science researcher can develop a optimized dosage form with least effort, money and manpower. Objectives: Objective of research work wasthe successful development of optimized floating bioadhesive tablets of glipizide using floating-bioadhesive potential of cellulosic polymer and carbomersusing quality by design (QbD) approach. Method: Quality Target Product Profile (QTPP) of drug delivery system was defined as well as critical quality attributes (CQAs) were identified. A face centered central composite design (CCD) was utilized in assessing the impact of individual critical material attribute (CMA) like Hydro Propyl Methyl Cellulose K4M(HPMC K4M)and Carbopol 934P (CP 934P) and their interactions, using least experimentation. Formulations were developed and quantitative impact on CQAs was determined using mathematical model. The optimized formulation was obtained and characterized for in-vitro as well as in-vivo parameters. Results: A Fishikawa diagram and Failure Mode and Effect Analysis (FMEA) were performed to identify potential failure modes associated with the dosage form. The optimum formulation was embarked upon using mathematical model developed yielding desired CQAs followed for confirmation of data. Sustained release drug delivery system was successfully developed by using QbD approach. In-vivo X-ray imaging in rabbit and γ-scintigraphic study in manconfirmed the buoyant nature of the mucoadhesive floating tablet for 8 h in the upper gastrointestinal tract. Conclusion: Optimized formulation shows phenomenal floating, bioadhesive properties and drug release retardation characteristics, utilizing a mixture of cost-effective polymers Hence, QbD approach may be regarded as an important tool in development of floating bioadhesive CR dosage forms.

scholarly journals The application of quality by design in the development of the liquid chromatography method to determine empagliflozin in the presence of its organic impurities

RSC Advances ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. 7313-7320
Author(s):  
Joanna Wittckind Manoel ◽  
Gabriele Bordignon Primieri ◽  
Lívia Maronesi Bueno ◽  
Nathalie Ribeiro Wingert ◽  
Nádia Maria Volpato ◽  
...  
Keyword(s):  
Quality Control ◽  
Liquid Chromatography ◽  
Quality By Design ◽  
Chromatography Method ◽  
Pharmaceutical Ingredients ◽  
Organic Impurities ◽  
Liquid Chromatography Method

Analysis of impurities is an important step in the quality control of pharmaceutical ingredients and final products.

Sign in / Sign up

Export Citation Format

Share Document