A state of the art in analytical quality-by-design and perspectives in characterization of nano-enabled medicinal products

Bastogne, Thierry; Caputo, Fanny; Prina‐Mello, Adriele; Borgos, Sven Even F.; Barberi‐Heyob, Muriel

doi:10.1016/j.jpba.2022.114911

Cited by 19 publications

(5 citation statements)

References 40 publications

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“…[ 12–16 ] Photo stability or degradation of Lixisenatide substance was performed as of ICH Q1B procedures. [ 12–17 ]…”

Section: Methodsmentioning

confidence: 99%

“…[12][13][14][15][16] Photo stability or degradation of Lixisenatide substance was performed as of ICH Q1B procedures. [12][13][14][15][16][17] To each round bottom (RB) flask, add 0.1N HCl (acid degradation), 0.1N NaOH (Alkali degradation), and 10% H 2 O 2 (oxidative degradation) separately. 10 mL stock solution of Lixisenatide was added to each RB flask and kept on reflux for 60 min at 70 °C.…”

Section: Forced Degradation Studiesmentioning

confidence: 99%

“…[16] The key benefits of analytical QbD include evaluation of risk assessment, identifying design space, and Quality target product profile (QTPP). [16][17][18] QbD contributes to the enhancement of method performance, the improvement of overall quality, and the support of the development of products that are both safe and effective in the industry. [18][19][20] Peak purity is very significant in stability indicating chromatographic approach.…”

Section: Introductionmentioning

confidence: 99%

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Estimation of Lexisinatide in Bulk and Tablets by RP‐UPLC Method Developed by Quality by Design Concept

Godela,

Venugopal,

Yagnambhatla

et al. 2024

Macromolecular Symposia

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The primary goal of the proposed study is to establish and validate a low‐cost, sensitive, reliable, and trouble‐free RP‐UPLC process with improved performance for the direct estimation of Lixisenatide in pure powder and fixed‐dose tablet form. The proposed method is optimized by implementing quality by design studies. The method is optimized using quadratic model of central composite design (CCD) of randomized response surface study. Successful separation of Lixisenatide is obtained by the use of Phenyl‐XBD (1.7 µm, 2.1 mm × 100 mm) column and a mobile phase of acetonitrile: 0.1% w/v OPA (60:40) with 0.5 mL min−1 flow rate. The separated Lixisenatide and its degradants are explorated with PDA detector which has the ability to provide comprehensive spectral information, rapid data acquisition, quantitative analysis, and peak purity analysis of all compounds simultaneously. The RT of Lixisenatide is found to be 1.34 min. The lowest concentration of Lixisenatide's limit of detection and limit of quantification makes guarantees regarding the method's sensitivity. For the provided range of linear concentrations (1.25–7.5 µg mL−1), the regression coefficient is found to be 0.999. The computed average percentage recoveries of Lixisenatide in spiked solutions ranged from 98.9% to 101.2%. The % degradation of Lixisenatide in the presence of a variety of forced conditions confirms the existing method's stability. Lixisenatide is significantly photo sensitive when compared to other stressful conditions such as acid, base hydrolysis, and oxidation. The proposed UPLC approach separates Lixisenatide with high sensitivity, a short retention time, and an affordable solvent system.

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“…[ 12–16 ] Photo stability or degradation of Lixisenatide substance was performed as of ICH Q1B procedures. [ 12–17 ]…”

Section: Methodsmentioning

confidence: 99%

Section: Forced Degradation Studiesmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Estimation of Lexisinatide in Bulk and Tablets by RP‐UPLC Method Developed by Quality by Design Concept

Godela,

Venugopal,

Yagnambhatla

et al. 2024

Macromolecular Symposia

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“…Rigorous quality control guarantees the reliability, safety, and efficacy of nanomaterial-based drug delivery systems. Standardized protocols enable comparison and evaluation of different production batches, ensuring consistency and quality assurance [ 219 ]. Advanced characterization techniques provide a comprehensive understanding of the NMs' physicochemical properties and performance, facilitating optimization and further development.…”

Section: Future Prospects Of Nanomaterialsmentioning

confidence: 99%

Nanomaterials as drug delivery agents for overcoming the blood-brain barrier: A comprehensive review

Kulkarni,

Patel,

Patel

et al. 2023

ADMET DMPK

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Background and Purpose: The blood-brain barrier (BBB), a critical interface of specialized endothelial cells, plays a pivotal role in regulating molecular and ion transport between the central nervous system (CNS) and systemic circulation. Experimental Approach: This review aims to delve into the intricate architecture and functions of the BBB while addressing challenges associated with delivering therapeutics to the brain. Historical milestones and contemporary insights underscore the BBB's significance in protecting the CNS. Key Results: Innovative approaches for enhanced drug transport include intranasal delivery exploiting olfactory and trigeminal pathways, as well as techniques like temporary BBB opening through chemicals, receptors, or focused ultrasound. These avenues hold the potential to reshape conventional drug delivery paradigms and address the limitations posed by the BBB's selectivity. Conclusion: This review underscores the vital role of the BBB in maintaining CNS health and emphasizes the importance of effective drug delivery through this barrier. Nanoparticles emerge as promising candidates to overcome BBB limitations and potentially revolutionize the treatment of CNS disorders. As research progresses, the application of nanomaterials shows immense potential for advancing neurological therapeutics, albeit with careful consideration of safety aspects.

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“…The proposed guidelines entail a systematic approach for analytical method development employing quality‐by‐design (QbD) paradigms, initiated by inclusion of a set of objectives, that is, analytical target profile (ATP), and emphasizing explicit understanding of the process and quality risk assessment, popularly designating the approach as analytical QbD (AQbD; Khurana et al, 2015; Sahu et al, 2018). Initially, the highly influential method parameters, or analytical factors, are identified using risk assessment and/or experimental factor screening procedures, which tend to exert significant effect on analytical method performance (Bastogne et al, 2022; Bhutani et al, 2014; Reddy et al, 2022). This approach has been documented not only as a more robust and precise paradigm, but also as more economical in terms of financial and times resources, for analytical method development through delineation of various critical analytical attributes (CAAs) and critical process parameters (Awotwe‐Otoo et al, 2012; Beg et al, 2016; Sandhu et al, 2016).…”

Section: Introductionmentioning

confidence: 99%

Quality by design‐steered development and validation of analytical and bioanalytical methods for raloxifene: Application of Monte Carlo simulations and variance inflation factor

Pant

Sharma

Saini

et al. 2023

Biomedical Chromatography

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A sensitive, rapid, reproducible, and economical HPLC method is reported for the quantification of raloxifene hydrochloride employing Quality by Design (QbD) principles. Factor screening studies, employing Taguchi design, indicated buffer volume percentage and isocratic flow rate as the critical method parameters (CMPs), which significantly influence the chosen critical analytical attributes, that is, tailing factor and theoretical plate number. Method conditions were subsequently optimized using face-centered cubic design with magnitude of variance inflation factor for assessing multicollinearity among CMPs. Method operable design region (MODR) was earmarked and liquid chromatographic separation optimized using 0.05 M citrate buffer, acetonitrile, and methanol (57:40:3 v/v/v) as ggmobile phase at 0.9 mL min À1 flow rate, λ max of 280 nm, and column temperature of 40 C. Validation of the developed analytical method was accomplished as per International Council on Harmonization (ICH) guidelines confirming high levels of linearity, precision, accuracy, robustness, and sensitivity. Application of Monte Carlo simulations enabled the attainment of best plausible chromatographic resolution and corroboration of the demarcated MODR. Establishment and validation of the bioanalytical method using rat plasma samples, along with forced degradation and stability studies, corroborated the aptness of developed HPLC methods for drug quantification in the biological fluids, as well as in bulk and marketed dosage forms.

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A state of the art in analytical quality-by-design and perspectives in characterization of nano-enabled medicinal products

Cited by 19 publications

References 40 publications

Estimation of Lexisinatide in Bulk and Tablets by RP‐UPLC Method Developed by Quality by Design Concept

Estimation of Lexisinatide in Bulk and Tablets by RP‐UPLC Method Developed by Quality by Design Concept

Nanomaterials as drug delivery agents for overcoming the blood-brain barrier: A comprehensive review

Quality by design‐steered development and validation of analytical and bioanalytical methods for raloxifene: Application of Monte Carlo simulations and variance inflation factor

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