Adaptation of the quality by design concept in early pharmaceutical development of an intranasal nanosized formulation

Pallagi, Edina; Ambrus, Rita; Szabó‐Révész, Piroska; Csóka, Ildikó

doi:10.1016/j.ijpharm.2015.06.018

Cited by 88 publications

(62 citation statements)

References 21 publications

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“…Previously, the authors successfully applied the QbD approach for the development of a nano-pharmaceutical formulation for nasal use [6].…”

Section: Identification Of Critical Quality Attributes (Cqas) and Crimentioning

confidence: 99%

“…As the output of the RA evaluation, Pareto diagrams [28] were generated showing the ranked parameters according to their potential impact on product quality. Using this software-based evaluation is relatively new in the literature [6,29].…”

Section: Ramentioning

confidence: 99%

“…The QbD method can be applied to the entire pharmaceutical production process, or to certain parts of it but also in the early research and development phase [2][3][4][5]. Its use in the early developments can help in having a time and cost-effective process, in closing the gap between the science and the industry, as well as can facilitate the innovation transfer process to introduce new drugs to market [6][7].…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

New aspects of developing a dry powder inhalation formulation applying the quality-by-design approach

Pallagi

Karimi

Ambrus

et al. 2016

International Journal of Pharmaceutics

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“…Previously, the authors successfully applied the QbD approach for the development of a nano-pharmaceutical formulation for nasal use [6].…”

Section: Identification Of Critical Quality Attributes (Cqas) and Crimentioning

confidence: 99%

Section: Ramentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

New aspects of developing a dry powder inhalation formulation applying the quality-by-design approach

Pallagi

Karimi

Ambrus

et al. 2016

International Journal of Pharmaceutics

Self Cite

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“…Each operation comes with its own sources of variability. Novel concepts, taken up by the regulatory agencies, require the “built-in” quality of a drug product, through a scientifically proven, quality by design approach, which is meant to predict and control all sources of errors 2–4…”

Section: Introductionmentioning

confidence: 99%

Risk assessment and experimental design in the development of a prolonged release drug delivery system with paliperidone

Iurian

Turdean

Tomuță

2017

DDDT

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This study focuses on the development of a drug product based on a risk assessment-based approach, within the quality by design paradigm. A prolonged release system was proposed for paliperidone (Pal) delivery, containing Kollidon® SR as an insoluble matrix agent and hydroxypropyl cellulose, hydroxypropyl methylcellulose (HPMC), or sodium carboxymethyl cellulose as a hydrophilic polymer. The experimental part was preceded by the identification of potential sources of variability through Ishikawa diagrams, and failure mode and effects analysis was used to deliver the critical process parameters that were further optimized by design of experiments. A D-optimal design was used to investigate the effects of Kollidon SR ratio (X1), the type of hydrophilic polymer (X2), and the percentage of hydrophilic polymer (X3) on the percentages of dissolved Pal over 24 h (Y1–Y9). Effects expressed as regression coefficients and response surfaces were generated, along with a design space for the preparation of a target formulation in an experimental area with low error risk. The optimal formulation contained 27.62% Kollidon SR and 8.73% HPMC and achieved the prolonged release of Pal, with low burst effect, at ratios that were very close to the ones predicted by the model. Thus, the parameters with the highest impact on the final product quality were studied, and safe ranges were established for their variations. Finally, a risk mitigation and control strategy was proposed to assure the quality of the system, by constant process monitoring.

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“…Foi realizado o teste T unicaudal (TOST) para equivalência considerando um nível de significância de 5%, e os limites de especificação de 90 a 135% de teor rotulado de neomicina. PERAMAN et al, 2015;PALLAGI et al, 2015). Quantidades do padrão foram pesados e diluídos com uma porção de ácido hidroclorídrico 0,01, e posteriormente em tampão fosfato pH 6,0 para obter as concentrações de 0,5; 1,0 e 2,0 UI/ml.…”

Section: Comparação Dos Ensaiosunclassified

Doseamento microbiológico de neomicina e bacitracina - desenvolvimento e validação de método rápido em microplacas

Francisco¹

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Adaptation of the quality by design concept in early pharmaceutical development of an intranasal nanosized formulation

Cited by 88 publications

References 21 publications

New aspects of developing a dry powder inhalation formulation applying the quality-by-design approach

New aspects of developing a dry powder inhalation formulation applying the quality-by-design approach

Risk assessment and experimental design in the development of a prolonged release drug delivery system with paliperidone

Doseamento microbiológico de neomicina e bacitracina - desenvolvimento e validação de método rápido em microplacas

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