Quality by design approach for the preparation of fat-soluble vitamins lipid injectable emulsion

Deng, Yanping; Zhong, Guifeng; Wang, Yi; Wang, Ni; Yu, Qing; Yu, Xiangbin

doi:10.1016/j.ijpharm.2019.118717

Cited by 13 publications

(2 citation statements)

References 38 publications

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“…From this study, they were concluded that by using Quality by design approach, lipid injectable emulsion for fat soluble vitamins was successfully prepared. 54…”

Section: Othersmentioning

confidence: 99%

Experimental Design: Approaches and Applications in Development of Pharmaceutical Drug Delivery System

Supare

Wadher

Umekar

2021

J. Drug Delivery Ther.

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Conventionally, all the delivery systems have been prepared by methodology of trial and error concept by manipulating one variable at a Time, but attainment of optimal formulation is not achievable. The systematic approach Design of Experiments (DoE) enables researchers to provide appropriate outline to develop a best optimized delivery system. Optimization techniques using DoE helps to provide effective and economical analytical tools to find the perfect solution for a particular problem. In screening designs, there is large number of screening factors in minimum number of experiments and beneficial to minimize the variables in a desired size therefore further experimentation may be performed easily by using these variables. Experimental designs and optimization techniques are the tools which are systematically used to categorize various types of problems that may influence development of pharmaceutical delivery system. Use of experimental design is the best approach to the screening and optimization of experimental factors. In the present review article we have focused on application of practically applicable experimental designs and optimization techniques for the development of quality and efficacious of pharmaceutical formulations such as, nanoparticles, Phytosomes, microspheres, liposomes, micells, films, nanostructured lipid carriers and tablets and which type of factors to be considered while optimization are also discussed. Keywords: Experimental design, Optimization, Applications, Drug delivery, Phytosomes, Nano delivery System.

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“…From this study, they were concluded that by using Quality by design approach, lipid injectable emulsion for fat soluble vitamins was successfully prepared. 54…”

Section: Othersmentioning

confidence: 99%

Experimental Design: Approaches and Applications in Development of Pharmaceutical Drug Delivery System

Supare

Wadher

Umekar

2021

J. Drug Delivery Ther.

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show abstract

“…Safety of the optimal emulsion was evaluated as acceptable through the determination of lysophospholipid content and an in vitro hemolysis assay. [75] Lyophilized liposomes…”

Section: Lipid Injectable Emulsionmentioning

confidence: 99%

Articulation of Quality By Design Elements for Product Development and its Unique Applications

Sitre¹,

Kamble²

2020

J. Drug Delivery Ther.

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Quality by Design (QbD) is a methodical approach to pharmaceutical product development that begins with predefined objectives and emphasizes product and process comprehension and process control based on sound science and quality risk management. Pharmaceutical development should lead to the design a quality product and its manufacturing process to meet the QTPP and CQA parameters. To arrive at the robust product development QbD articulation is important which is missing in most of the reviews. This review articulates the QbD elements in the product development. QbD process stars with identification of QTPP and source CQA from QTPP. CMAs and CPPs are derived with risk assessment from the product ingredients and process. Their impact on the CQAs can be studies with DoE tools. The information and knowledge gained from pharmaceutical development studies and manufacturing experience provide scientific understanding to support the design space and control strategy. Product process follows life cycle management approach with continuous improvement. PAT tools are utilized for the online monitoring of the processes. This review paper is dedicated to provide QbD element articulation in product development and its unique applications in the various areas of the product development such as Biotechnology, Nanotechnology products, Nasal products, Inhalation, Injectable products, Targeted drug delivery, complex Solid oral, Transdermal and topical products, Bioavailability and dissolution enhancement, Analytical processes and API manufacturing etc. Current trends in the technical application of the PAT tools are discussed. Keywords: Quality by Design (QbD), Quality Target Product Profile (QTPP), Critical Quality Attributes (CQA) and Design of Experiment (DoE): Product development application of QbD

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Quality by Design for Parenteral Formulations

Ergin,

Uner

2024

Introduction to Quality by Design (QbD)

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Quality by design approach for the preparation of fat-soluble vitamins lipid injectable emulsion

Cited by 13 publications

References 38 publications

Experimental Design: Approaches and Applications in Development of Pharmaceutical Drug Delivery System

Experimental Design: Approaches and Applications in Development of Pharmaceutical Drug Delivery System

Articulation of Quality By Design Elements for Product Development and its Unique Applications

Quality by Design for Parenteral Formulations

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