Quality by design (QbD) in the formulation and optimization of liquid crystalline nanoparticles (LCNPs): A risk based industrial approach

Waghule, Tejashree; Dabholkar, Neha; Gorantla, Srividya; Rapalli, Vamshi Krishna; Saha, Ranendra Narayan; Singhvi, Gautam

doi:10.1016/j.biopha.2021.111940

Cited by 43 publications

(24 citation statements)

References 60 publications

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“…Table 1 and Table 2 present the estimated interrelationships of the selected critical factors for CMA and CPP factors. High risk represents risk that is not acceptable due to safety/efficacy issues; medium risk is acceptable but needs investigation; and low risk means no further investigation is needed [ 27 ]. The classification of the impact of each factor was realized based on previous reports, which allowed us to obtain knowledge of space development and identify the principal high-risk factors that may impact the formulation of metal-based drug encapsulation in niosomes.…”

Section: Resultsmentioning

confidence: 99%

Development and In Vitro and In Vivo Evaluation of an Antineoplastic Copper(II) Compound (Casiopeina III-ia) Loaded in Nonionic Vesicles Using Quality by Design

Aguilar-Jiménez

González-Ballesteros

Dávila-Manzanilla

et al. 2022

IJMS

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In recent decades, the interest in metallodrugs as therapeutic agents has increased. Casiopeinas are copper-based compounds that have been evaluated in several tumor cell lines. Currently, casiopeina III-ia (CasIII-ia) is being evaluated in phase I clinical trials. The aim of the present work is to develop a niosome formulation containing CasIII-ia for intravenous administration through a quality-by-design (QbD) approach. Risk analysis was performed to identify the factors that may have an impact on CasIII-ia encapsulation. The developed nanoformulation optimized from the experimental design was characterized by spectroscopy, thermal analysis, and electronic microscopy. In vitro drug release showed a burst effect followed by a diffusion-dependent process. The niosomes showed physical stability for at least three months at 37 °C and 75% relative humidity. The in vitro test showed activity of the encapsulated CasIII-ia on a metastatic breast cancer cell line and the in vivo test of nanoencapsulated CasIII-ia maintained the activity of the free compound, but showed a diminished toxicity. Therefore, the optimal conditions obtained by QbD may improve the scaling-up process.

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Section: Resultsmentioning

confidence: 99%

Development and In Vitro and In Vivo Evaluation of an Antineoplastic Copper(II) Compound (Casiopeina III-ia) Loaded in Nonionic Vesicles Using Quality by Design

Aguilar-Jiménez

González-Ballesteros

Dávila-Manzanilla

et al. 2022

IJMS

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“…The identification of process variables that affect the quality attributes of the final product require PAT innovative sensors that are capable of real-time physical and chemical characterization and analysis. In order to fulfill the ICH and QbD requirements for manufacturing of robust nanoparticles formulations, real-time monitorization using PAT instruments is needed [ 70 , 71 ]. Currently, a PAT instrument is implemented for nanoemulations and nanosuspensions manufacturing for real-time size and size distribution monitorization [ 72 ].…”

Section: Quality By Design (Qbd) Approach In Non-viral Vector Develop...mentioning

confidence: 99%

“…The wide variety of real-time process analyzers used to monitor process parameters or material attributes generate a high number of complex data sets. The comprehension of statistical DoE, response surface methodology, optimization and multivariate data analysis is important for understanding the multi-factorial relationship between the variables [ 70 , 71 , 73 ]. Statistical methods such as regression analysis and Analysis of Variance (ANOVA) are the tools for data analysis [ 14 ].…”

Section: Quality By Design (Qbd) Approach In Non-viral Vector Develop...mentioning

confidence: 99%

A Quality by Design Approach in Pharmaceutical Development of Non-Viral Vectors with a Focus on miRNA

et al. 2022

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Cancer is the leading cause of death worldwide. Tumors consist of heterogeneous cell populations that have different biological properties. While conventional cancer therapy such as chemotherapy, radiotherapy, and surgery does not target cancer cells specifically, gene therapy is attracting increasing attention as an alternative capable of overcoming these limitations. With the advent of gene therapy, there is increasing interest in developing non-viral vectors for genetic material delivery in cancer therapy. Nanosystems, both organic and inorganic, are the most common non-viral vectors used in gene therapy. The most used organic vectors are polymeric and lipid-based delivery systems. These nanostructures are designed to bind and protect the genetic material, leading to high efficiency, prolonged gene expression, and low toxicity. Quality by Design (QbD) is a step-by-step approach that investigates all the factors that may affect the quality of the final product, leading to efficient pharmaceutical development. This paper aims to provide a new perspective regarding the use of the QbD approach for improving the quality of non-viral vectors for genetic material delivery and their application in cancer therapy.

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“…It is essential to verify the method in the development of analytical methods with the purpose of evaluating the performance of the method. Validation parameters encompass specificity, repeatability, precision, accuracy, linearity, limit of quantitation, limit of detection as well as robustness [39].…”

Section: Fundamentals Of Doementioning

confidence: 99%

Design of experiment techniques for the optimization of chromatographic analysis conditions: A review

et al. 2022

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Design of experiment (DoE) techniques have been widely used in the field of chromatographic parameters optimization as a valuable tool. A systematic literature review of the available DoE techniques applied to the development of a chromatographic analysis method is presented in this paper. First, the most common available designs and the implementation steps of DoE are comprehensively introduced. Then the studies in recent 10 years for the application of DoE techniques in various chromatographic techniques are discussed, such as capillary electrophoresis, liquid chromatography, gas chromatography, thin‐layer chromatography, and high‐speed countercurrent chromatography. Current problems and future outlooks are finally given to provide a certain inspiration of research in the application of DoE techniques to the different chromatographic techniques field. This review contributes to a better understanding of the DoE techniques for the efficient optimization of chromatographic analysis conditions, especially for the analysis of complex systems, such as multicomponent drugs and natural products.

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Quality by design (QbD) in the formulation and optimization of liquid crystalline nanoparticles (LCNPs): A risk based industrial approach

Cited by 43 publications

References 60 publications

Development and In Vitro and In Vivo Evaluation of an Antineoplastic Copper(II) Compound (Casiopeina III-ia) Loaded in Nonionic Vesicles Using Quality by Design

Development and In Vitro and In Vivo Evaluation of an Antineoplastic Copper(II) Compound (Casiopeina III-ia) Loaded in Nonionic Vesicles Using Quality by Design

A Quality by Design Approach in Pharmaceutical Development of Non-Viral Vectors with a Focus on miRNA

Design of experiment techniques for the optimization of chromatographic analysis conditions: A review

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