Application of quality by design principles in the development and evaluation of semisolid drug carrier systems for the transdermal delivery of lidocaine

Bakonyi, Mónika; Berkó, Szilvia; Kovács, Anita; Budai-Szűcs, Mária; Kis, Nikolett; Erős, Gábor; Csóka, Ildikó; Csányi, Erzsébet

doi:10.1016/j.jddst.2017.12.001

Cited by 30 publications

(19 citation statements)

References 36 publications

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“…The others are polyethylene glycol ricinolates, as well as the corresponding free glycols [7]. Kolliphor ® EL (EL), being the most often used Kolliphor, was applied as a vehicle in the case of solubilization of some hydrophobic drugs, including cyclosporin A, diazepam, propofol and paclitaxel [8]. However, some researchers stated that EL is not an inert vehicle but exerts a range of biological effects, some of which have important clinical implications.…”

Section: Introductionmentioning

confidence: 99%

Temperature Effect on the Adsorption and Volumetric Properties of Aqueous Solutions of Kolliphor®ELP

Szaniawska

Krawczyk

2020

Molecules

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Density, viscosity and surface tension of Kolliphor ® ELP, the nonionic surfactant aqueous solutions were measured at temperature T = 293-318 K and at 5K interval. Steady-state fluorescence measurements have been also made using pyrene as a probe. On the basis of the obtained results, a number of thermodynamic, thermo-acoustic and anharmonic parameters of the studied surfactant have been evaluated and interpreted in terms of structural effects and solute-solvent interactions. The results suggest that the molecules of studied surfactant at concentrations higher than the critical micelle concentration act as structure makers of the water structure.Molecules 2020, 25, 743 2 of 13 hand to describe the behavior of surfactants in relation to two non-miscible phases and the range of temperatures at which they are active, some adsorption and volumetric properties of the solution of such surfactants are needed. Thus, the purpose of the presented studies was to determine some adsorption, volumetric, thermo-acoustic as well as anharmonic properties of aqueous solutions of Kolliphor ® ELP (ELP), a purified grade of EL, by surface tension, density and viscosity measurements at T = 293-318 K with 5 K interval. Moreover, the properties of the solutions were studied by means of steady-state fluorescence measurements. Based on the results, the analysis was applied to study different molecular interactions in the solutions taking into account the change of these properties depending on concentration and temperature. Results and Discussion

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Section: Introductionmentioning

confidence: 99%

Temperature Effect on the Adsorption and Volumetric Properties of Aqueous Solutions of Kolliphor®ELP

Szaniawska

Krawczyk

2020

Molecules

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“…Polyethylene glycol ricinoleate and the corresponding free glycols are the other constituents (Christiansen et al, 2010). Kolliphor EL (EL), the most common of all Kolliphors, can be used as a solubilization vehicle for some hydrophobic drugs including cyclosporin A, diazepam, propofol, and paclitaxel (Bakonyia et al, 2018;Bali et al, 2011;Chen et al, 2008;Constantinides and Wasan, 2007;Cuiné et al, 2008;Gao et al, 2003;Sadurni et al, 2005;Seelig and Gerebtzoff, 2006;Wang et al, 2004). Moreover, mixed micelles of nonionic surfactants are common in industry (Rosen, 2004).…”

Section: Introductionmentioning

confidence: 99%

Determination of Acoustical Parameters of Aqueous Solution of Kolliphors Binary Mixtures Using Density, Speed of Sound, Viscosity, and Surface Tension Measurements

Szaniawska

Terpiłowski

2019

J Surfact & Detergents

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Measurements of density, speed of sound, and surface tension as well as viscosity of aqueous Kolliphor® ELP (ELP) and Kolliphor® RH 40 (RH40) solutions as well as binary mixtures at different surfactant mole fractions were made at 293 K to investigate their aggregation behavior. The free volume, internal pressure, and molar cohesive energy were calculated and compared to the specific acoustic impedance and intermolecular free length to obtain qualitative information about the character of interactions between the surfactant molecules in the mixture through the water phase.

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“…The one-way analysis of variance (ANOVA-Dunnett) with Prism 8 for Windows software (GraphPad Software Inc., La Jolla, CA, USA) was used to analyze the results statistically. The differences were significant if p < 0.0001**** versus the control [18].…”

Section: Discussionmentioning

confidence: 99%

Investigation of Silicone-Containing Semisolid in Situ Film-Forming Systems Using QbD Tools

et al. 2019

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The aim of our research work was to develop dermally applicable, semisolid film-forming systems (FFSs) containing silicones, which form a film on the skin in situ, with suitable mechanical properties for skin application. FFSs were developed and investigated by means of the Quality by Design (QbD) methodology. With this QbD approach, the initial risk assessment defines the critical quality attributes (CQAs), the critical material attributes (CMAs) and the critical process parameters (CPPs) to ensure the required quality. Different semisolid systems were formed with or without silicones. During the initial risk assessment, three CQAs, namely skin adhesion, film flexibility and burst strength, were found to be critical attributes, while film appearance, film integrity and the drying time of the semisolid system, were found to be medium attributes. These parameters were investigated. The initial risk assessment also showed that there are three high CMAs: the type of silicones, film-forming excipients, drying excipients, and that there was one medium CMA: viscosity-enhancing excipients. Based on our results, the silicone content had a great effect on the film-forming systems. Different silicones affected the mechanical properties of the films in varying ways, decreased the drying time and showed promising results regarding the drying mechanism.

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Application of quality by design principles in the development and evaluation of semisolid drug carrier systems for the transdermal delivery of lidocaine

Cited by 30 publications

References 36 publications

Temperature Effect on the Adsorption and Volumetric Properties of Aqueous Solutions of Kolliphor®ELP

Temperature Effect on the Adsorption and Volumetric Properties of Aqueous Solutions of Kolliphor®ELP

Determination of Acoustical Parameters of Aqueous Solution of Kolliphors Binary Mixtures Using Density, Speed of Sound, Viscosity, and Surface Tension Measurements

Investigation of Silicone-Containing Semisolid in Situ Film-Forming Systems Using QbD Tools

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