A Quality by design (QbD) approach on starch-based nanocapsules: A promising platform for topical drug delivery

Marto, Joana; Gouveia, Luís F.; Gonçalves, Lídia; Gaspar, Diana P.; Pinto, Pedro Contreiras; Carvalho, Filomena A.; Oliveira, Eduardo Frederico Cabral de; Ribeiro, Helena Margarida; Almeida, António J.

doi:10.1016/j.colsurfb.2016.03.039

Cited by 48 publications

(15 citation statements)

References 25 publications

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“…The size distribution of the emulsions droplets was measured by light scattering using a Malvern Mastersizer 2000 (Malvern Instruments, Worcestershire, UK) coupled with a Hydro S accessory as previously detailed by Marto et al …”

Section: Methodssupporting

confidence: 94%

Characterization of Portuguese Thymbra capitata, Thymus caespititius and Myrtus communis essential oils in topical formulations

Neves

Marto

Duarte

et al. 2017

Flavour & Fragrance J

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As the personal care industry evolves, formulators are seeking innovative solutions for their formulations' needs, and for ingredients that can offer multiple functions within formulations. Considering that essential oils (EOs) may present a wide spectrum of biological activities, the composition, antimicrobial and antioxidant activity of Portuguese Thymbra capitata, Thymus caespititius and Myrtus communis EOs were assessed in order to evaluate them as preservatives and antioxidants in topical emulsions. The in vivo safety application of some emulsions was also tested. T. capitata EO was mainly constituted by carvacrol (73%), whereas α‐terpineol (27%), p‐cymene (14%) and carvacrol (10%) dominated Th. caespititius EO, and 1,8‐cineole (37%) was dominant in M. communis EO. The minimum inhibitory concentration of T. capitata, Th. caespititius and M. communis EOs was 0.4 μg/mL against C. albicans and ranged between 0.4 and 30.7 μg/mL against A. brasiliensis. Gram‐positive bacteria were more susceptible to each EO than Gram‐negative bacteria. T. capitata EO showed significantly higher antioxidant activity than Th. caespititius and M. communis EOs. EOs incorporated in emulsions showed preservative activity against all microorganisms tested and T. capitata EO emulsions showed powerful reactive oxygen species (ROS) scavenging effects. A safety evaluation study was performed with 0.10% and 0.01% T. capitata EO emulsions according to the Human Repeat Insult Patch Test (HRIPT). All emulsions were considered safe for topical application. T. capitata, Th. caespititius and M. communis significantly improved the microbiological quality of the prepared emulsions and may constitute a powerful alternative to the current preservatives and antioxidants for use in topical formulations.

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Section: Methodssupporting

confidence: 94%

Characterization of Portuguese Thymbra capitata, Thymus caespititius and Myrtus communis essential oils in topical formulations

Neves

Marto

Duarte

et al. 2017

Flavour & Fragrance J

Self Cite

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“…To reduce the impact of the raw materials on the CQAs, medium viscosity alginate and pregelatinized modified starch were selected. As shown in previous studies, the use of a pregelatinized modified starch results in clear and stable dispersions with low polymer concentrations and eliminates the need for heating since this polymer is cold-water soluble [25].…”

Section: Risk Estimation Matrix (Rem)mentioning

confidence: 68%

Effects of Starch Incorporation on the Physicochemical Properties and Release Kinetics of Alginate-Based 3D Hydrogel Patches for Topical Delivery

et al. 2020

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The development of printable hydrogel inks for extrusion-based 3D printing is opening new possibilities to the production of new and/or improved pharmaceutical forms, specifically for topical application. Alginate and starch are natural polysaccharides that have been extensively exploited due to their biocompatibility, biodegradability, viscosity properties, low toxicity, and relatively low cost. This research work aimed to study the physicochemical and release kinetic effects of starch incorporation in alginate-based 3D hydrogel patches for topical delivery using a quality by design approach. The incorporation of a pregelatinized starch is also proposed as a way to improve the properties of the drug delivery system while maintaining the desired quality characteristics. Critical material attributes and process parameters were identified, and the sensitivity and adequacy of each parameter were statistically analyzed. The impact of alginate, starch, and CaCl2·2H2O amounts on relevant quality attributes was estimated crosswise. The amount of starch revealed a synergetic impact on porosity (p = 0.0021). An evident increase in the size and quantity of open pores were detected in the as printed patches as well as after crosslinking (15.6 ± 5.2 µm). In vitro drug release studies from the optimized alginate-starch 3D hydrogel patch, using the probe Rhodamine B, showed an initial high burst release, followed by a controlled release mechanism. The results obtained also showed that the viscoelastic properties, printing accuracy, gelation time, microstructure, and release rates can be modulated by varying the amount of starch added to the system. Furthermore, these results can be considered an excellent baseline for future drug release modulation strategies.

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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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A Quality by design (QbD) approach on starch-based nanocapsules: A promising platform for topical drug delivery

Cited by 48 publications

References 25 publications

Characterization of Portuguese Thymbra capitata, Thymus caespititius and Myrtus communis essential oils in topical formulations

Characterization of Portuguese Thymbra capitata, Thymus caespititius and Myrtus communis essential oils in topical formulations

Effects of Starch Incorporation on the Physicochemical Properties and Release Kinetics of Alginate-Based 3D Hydrogel Patches for Topical Delivery

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

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