Quality by design approach for optimizing the formulation and physical properties of extemporaneously prepared orodispersible films

Visser, Jerry; Dohmen, Willem M. C.; Hinrichs, Wouter L. J.; Breitkreutz, Jörg; Frijlink, Henderik W.; Woerdenbag, Herman J.

doi:10.1016/j.ijpharm.2015.03.005

Cited by 93 publications

(56 citation statements)

References 12 publications

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“…However, at HPC level of 80 g, plasticiser did not have a significant effect on stiffness. Thus, the plasticising effect by PEG 4500 negatively influenced the mechanical properties of the film at HPC concentration of 40 and 60 g. In a study conducted by Visser et al, [35] on orally disintegrating films, higher percentage of glycerol (plasticiser) corresponded to decreased tensile strength, further supporting our results. Another finding from this study was that as the concentration of HPMC increased from low to medium level, there was a decrease in stiffness, however, a further increase in the concentration of HPMC (from 10 to 20 g) resulted in an increase in stiffness values.…”

Section: Stiffnesssupporting

confidence: 90%

Effects of formulation composition on the characteristics of mucoadhesive films prepared by hot-melt extrusion technology

Bhagurkar

Darji

Lakhani

et al. 2018

Journal of Pharmacy and Pharmacology

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Objectives To investigate the effects of formulation composition on the physico‐chemical and drug release properties of mucoadhesive buccal films prepared by melt extrusion technology, using a response surface methodology. Methods Salbutamol sulphate, an antiasthmatic drug was used for this study. Klucel hydroxypropylcellulose (HPC) EF (film‐forming polymer), Benecel hydroxypropylmethylcellulose (HPMC) K‐15M (drug release retardant) and polyethylene glycol (PEG) 4500 (plasticiser) were the three independent factors utilised for the study. The responses were fitted to a full quadratic model and P‐values for each of the factors were used to determine their significance on the film characteristics. Key findings Films were successfully extruded using the corotating twin‐screw extruder. The torque during extrusion was found to be significantly affected by all the three factors and no interaction between factors was observed. A significant interaction was observed between HPC and PEG 4500 for stiffness of films. For disintegration time and swelling index, a significant interaction was found between HPC and HPMC. The in vitro % drug release was directly correlated with HPMC content and not with other factors and varied from 69–89% at 4 h. Conclusions The influence of extrusion process and formulation parameters on salbutamol sulphate films was elucidated, indicating the use of melt extrusion as a feasible method for film preparation.

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Section: Stiffnesssupporting

confidence: 90%

Effects of formulation composition on the characteristics of mucoadhesive films prepared by hot-melt extrusion technology

Bhagurkar

Darji

Lakhani

et al. 2018

Journal of Pharmacy and Pharmacology

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“…O ICH Q9 (24) sugere o emprego de modelos de RA tais como o "Diagrama de Ishkawa", a "Análise preliminar de perigo" (Preliminary Hazard Analysis, PHA), a "Análise da árvore de falhas" (Faut tree analysis, FTA), o mapeamento de risco, o "Estudo de perigo e operabilidade" (Hazard and operability study, HAZOP), a filtração e priorização de risco (Risk Ranking and Filtering) e, mais recentemente, a "Análise de criticidade e modo de efeito de falhas" (Failure Mode and Effects Analysis, FMECA) (12,19), uma técnica que analisa os potenciais modos de falhas de um processo e de seus efeitos com relação à confiabilidade e segurança. De modo geral, a condução de uma RA depende da profundidade do conhecimento que se tem do objeto de estudo (12,19,24).…”

Section: Figuraunclassified

“…O comitê gestor da Conferência Internacional de Harmonização (ICH) enfatizou a inexistência de obrigatoriedade no cumprimento das diretrizes estabelecidas nos guias, entretanto alertaram que as recomendações refletem as perspectivas das agências regulatórias sobre a qualidade dos produtos farmacêuti-cos (3,9,24).…”

Section: Quality By Design (Qbd) E As Agências Regulatóriasunclassified

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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“…Solvent casting is mainly limited by the need for a solvent, aqueous or organic. Given the high 45 heat of vaporization of water, aqueous solutions can require long drying times, up to 24 hours (Kianfar et al, 2012;Shen et al, 2013;Sievens-Figueroa et al, 2012;Visser et al, 2015). The use of organic solvents is particularly undesirable from an environmental perspective and requires the manufacturing facility to incorporate solvent handling (i.e.…”

Section: Introductionmentioning

confidence: 99%

Influence of process parameters on the preparation of pharmaceutical films by electrostatic powder deposition

Prasad

LaFountaine

Keen

et al. 2016

International Journal of Pharmaceutics

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Electrostatic powder deposition (ESPD) has been developed as a solvent-free method to prepare pharmaceutical films. The aim of this work was to investigate the influence of process parameters during (1) electrostatic powder deposition, (2) curing, and (3) removal of the film from the substrate on the properties of the film. Polyethylene oxide (PEO) was used as the model polymer and stainless steel 316 as the substrate. Deposition efficiency (i.e. deposited weight) was measured with varying charging voltage, gun tip to substrate distance, and environmental humidity. Scanning electron microscopy was utilized to assess film formation, and adhesive and mechanical strength of films were measured with varying cure temperature and time. Adhesive strength was measured for films prepared on substrates of varying surface roughness. When deposition was performed at low humidity conditions, 25%RH, process parameters did not significantly affect deposition behavior. At 40%RH, increasing deposition efficiency with decreasing gun tip to substrate distance and increasing voltage (up to 60kV) was observed. Complete film formation was seen by 30min at 80°C, compared to lower curing temperatures and times. All films were readily removed from the substrates. The results show the ESPD process can be modified to produce films with good mechanical properties (e.g. tensile strength>0.06MPa), suggesting it is a promising dry powder process for preparing pharmaceutical films.

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Quality by design approach for optimizing the formulation and physical properties of extemporaneously prepared orodispersible films

Cited by 93 publications

References 12 publications

Effects of formulation composition on the characteristics of mucoadhesive films prepared by hot-melt extrusion technology

Effects of formulation composition on the characteristics of mucoadhesive films prepared by hot-melt extrusion technology

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

Influence of process parameters on the preparation of pharmaceutical films by electrostatic powder deposition

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