Improvement of a stability-indicating method by Quality-by-Design versus Quality-by-Testing: A case of a learning process

Hubert, Cédric; Lebrun, Philippe; Houari, Sabah; Ziemons, Eric; Rozet, Eric; Hubert, Philippe

doi:10.1016/j.jpba.2013.09.026

Cited by 55 publications

(30 citation statements)

References 17 publications

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“…O "planejamento experimental" (DoE) é realizado por meio de programas específicos (Design Expert, MatLab, JMP, SIMCA, entre outros) que se diferenciam pela inteface, opções de desenho e disponibilidade de ferramentas de análise de dados (21,22). Estes produtos também auxiliam a determinar o modelo que melhor representa o objeto de investigação por meio de tratamento estatístico (21,23). Assessement, RA).…”

Section: Figuraunclassified

Quality by Design (Qbd) Como Ferramenta Para Otimização Dos Processos Farmacêuticos

Bezerra

Rodrigues

2017

Infarma

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The pharmaceutical industry is constantly evolving. The harmonization of production standards, with the aim of guaranteeing efficacy, safety and quality of medicines, is one of the greatest challenges. The concept of "Quality by design" (QbD) proposes a systematic approach, based on scientific knowledge and risk management associated with the manufacturing process. In this approach, quality is inversely proportional to variability. The implementation of the QbD concept is a promising tool for pharmaceutical production, since it allows the production of medicines by means of risk prediction, increasing the possibility of generating products with efficiency, safety and quality assured, together with the reduction of costs. The implementation of this concept requires not only new technologies, but the change in the concept of quality.Keywords: pharmaceutical processes; quality by design; process analytical techniques. RESUMOO setor farmacêutico está em constante evolução. A harmonização de normas de produção, com o intuído de garantir eficácia, segurança e qualidade dos medicamentos, consiste em um dos maiores desafios. O conceito "qualidade baseada no projeto" (Quality by design, QbD) propõe uma abordagem sistemática, fundamentada no conhecimento científico e no gerenciamento do risco associado ao processo de fabricação. Nesta abordagem, qualidade é inversamente proporcional a variabilidade. A implementação do conceito de QbD constitui uma ferramenta promissora para a produção farmacêutica pois permite a produção de medicamentos por meio da previsão de riscos, ampliando a possibilidade de gerar produtos com eficácia, segurança e qualidade assegurados, aliado a redução de custos. A implementação deste conceito exige não somente novas tecnologias, mas a mudança no conceito de qualidade.Palavras-chave: processos farmacêuticos; qualidade baseada no projeto; técnicas analíticas de processo INTRODUÇÃO A produção de medicamentos inclui uma série de processos farmacêuticos, caracterizados por uma sequência de operações unitárias, que realizam transformações químicas ou físicas em matérias-primas, com o fim de gerar produtos com eficácia, segurança e qualidade assegurados (1). Estabelecidos durante o desenvolvimento dos produtos, os processos farmacêuticos devem ser submetidos a aprovação por órgãos regulatórios para concessão de registro de comercialização, o qual assegura que a empresa comprovou ter condições de fornecer produtos de qualidade desejada de forma consistente, conforme as exigências regulatórias (2,3).Apesar do rigor das agências regulatórias na elaboração de normas e guias para a produção farmacêutica, estes requerimentos apresentam limitações, e falhas nos processos farmacêuticos são comumente observadas, o

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Section: Figuraunclassified

Quality by Design (Qbd) Como Ferramenta Para Otimização Dos Processos Farmacêuticos

Bezerra

Rodrigues

2017

Infarma

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“…In pharmaceutical analysis, most of analytical QbD methods concerned chromatography , while a few papers have been dedicated to CE . Despite the attractive application of QbD, most of the currently published analytical methods are still optimized without considering QbD principles, and even neglecting multivariate techniques.…”

Section: Introductionmentioning

confidence: 99%

The successful binomium of multivariate strategies and electrophoresis for the Quality by Design separation of a class of drugs: the case of triptans

et al. 2015

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Quality by Design (QbD) approach was followed having as analytical target profile the determination of different antimigraine drugs (seven triptans, TRP) available on the market. Multivariate strategies were used for defining the design space and solvent-modified MEKC was the selected analytical method. The versatility of electrophoretic technique, allowing a fine modulation of experimental parameters, made it possible to define the design space (DS). The DS limited a suitable range of experimental parameters in which all possible combinations of variables led to an electrokinetic method able to determine all the considered analytes with a predefined quality. Design of experiments and risk analysis fully assisted the method development from the initial investigation of MEKC knowledge space to the DS definition and finally to the control strategy. Applying the working operative conditions, the baseline separation of TRP was obtained in less than 9 min. The method was finally used for the quantification of three TRP in different pharmaceutical products.

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“…This guidance, followed by International Conference on Harmonization Q8, gave a new dimension to product development and consequently, caused many changes in product development and control. A literature survey has shown that there are many papers dealing with Quality by Design approach in method development (Lebrun et al 2008;Molnár, Rieger, and Monks 2010;Debrus et al 2011;Monks et al 2012;Cela et al 2013;Furlanetto et al 2013;Kormány, Molnár, and Rieger 2013;Mbinze et al 2013;Orlandini, Pinzauti, and Furulanetto 2013;Rozet et al 2013;Schmidt and Molnár 2013;Hubert et al 2014). However, despite the availability of previous studies, development of a new method demands separate attention because each mixture possesses special characteristics and requires an adjustment of investigation strategy.…”

Section: Introductionmentioning

confidence: 99%

Quality by Design Determination of Diclofenac Potassium and its Impurities by High-Performance Liquid Chromatography

Tumpa

Miladinović²,

Rakić

et al. 2015

Analytical Letters

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2A liquid chromatography method is reported for the determination of diclofenac potassium and its impurities using Quality by Design criteria. Central composite design was used for the investigation of the influence of critical parameters on performance that included the methanol concentration in the mobile phase, the pH of the aqueous phase, and the potassium dihydrogen phosphate concentration in the aqueous phase. Mathematical models enabled theoretical examination of experimental space to achieve maximal separation in minimal analysis time. A Monte Carlo simulation was used to evaluate the risk of uncertainty in model predictions, to adjusting process parameters, and to identify design space. Fractional factorial design was employed for robustness testing and method was fully validated. Optimal conditions were a C18 150 mm  4.6 mm, 5 m particle size column; a methanol -68.3 mmol L 1 potassium dihydrogenphosphate (68.7:31.3, v/v) mobile phase at pH 3.0, a flow rate of 1 mL min 1 , a column temperature of 25C, and ultraviolet detection at 254 nm.

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Improvement of a stability-indicating method by Quality-by-Design versus Quality-by-Testing: A case of a learning process

Cited by 55 publications

References 17 publications

Quality by Design (Qbd) Como Ferramenta Para Otimização Dos Processos Farmacêuticos

Quality by Design (Qbd) Como Ferramenta Para Otimização Dos Processos Farmacêuticos

The successful binomium of multivariate strategies and electrophoresis for the Quality by Design separation of a class of drugs: the case of triptans

Quality by Design Determination of Diclofenac Potassium and its Impurities by High-Performance Liquid Chromatography

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