Special Issue "Quality by Design (QbD) for Topical Dermatological and Transdermal Product Development"

A special issue of Pharmaceutics (ISSN 1999-4923).

Deadline for manuscript submissions: 15 August 2020.

Special Issue Editors

Prof. Dr. Heather Benson
E-Mail Website
Guest Editor
School of Pharmacy and Biomedical Sciences, Curtin Health Innovation Research Institute, Curtin University, GPO Box U 1987, Perth, Western Australia 6845, Australia
Interests: topical and transdermal drug delivery; penetration enhancement; nanotechnology; skin permeation mechanisms
Dr. Yousuf Mohammed
E-Mail Website
Guest Editor
Diamantina Institute, The University of Queensland, Translation Research Institute, 37 Kent St, Woolloongabba, QLD 4102, Australia
Interests: topical and transdermal drug delivery; penetration enhancement; nanotechnology; skin permeation mechanisms
Dr. Jeffrey E. Grice
E-Mail Website
Guest Editor
Therapeutics Research Centre, The University of Queensland Diamantina Institute, The University of Queensland, 37 Kent St, Woolloongabba, QLD 4102, Australia
Interests: topical and transdermal drug delivery; penetration enhancement; nanotechnology; dermatopharmacokinetics; skin permeation mechanisms
Prof. Dr. Michael Roberts
E-Mail Website
Guest Editor
Diamantina Institute, The University of Queensland, Translation Research Institute, 37 Kent St, Woolloongabba, QLD 4102, Australia and,
School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, Australia and, Therapeutic Research Centre, Basil Hetzel Institute for Translational Medical Research, The Queen Elizabeth Hospital, Adelaide, Australia
Interests: topical and transdermal drug delivery; penetration enhancement; nanotechnology; dermatopharmacokinetics; skin permeation mechanisms

Special Issue Information

Dear Colleagues,

The Quality by Design (QbD) approach can make the drug development and regulatory pathway more efficient, leading to the availability of high quality topical dermatological and transdermal products more quickly and reducing cost for the health care system and individual consumers. Implementation of the QbD approach involves the definition of the quality target product profile (QTPP) and critical quality attributes (CQAs) of a drug product, and the accomplishment of risk assessment to identify critical material attributes (CMAs) and critical process parameters (CPPs), the definition of a design space through design of experiments (DoEs), the establishment of a control strategy, and the continual improvement and innovation throughout the product life cycle. One of the critical areas of research is the definition of CQAs, the experimental models to evaluate those CQAs, and their application in the drug development process. This Special Issue is focused on the development and evaluation of CQAs for topical and transdermal products, ranging from simple semisolids and patches to nanotechnology formulations. Understanding the interrelationships between formulation components and CQAs, and their effect on efficacy and safety is critical to good topical or transdermal product design and performance.

Prof. Dr. Heather Benson
Dr. Yousuf Mohammed
Dr. Jeffrey E. Grice
Prof. Dr. Michael Roberts
Guest Editors

Manuscript Submission Information

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Keywords

  • Quality by design
  • Critical quality attributes
  • Topical formulation
  • Transdermal formulation
  • Skin delivery
  • In vivo in vitro correlation
  • Formulation–drug–skin interactions

Published Papers (4 papers)

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Research

Open AccessArticle
Novel Nanocarriers for Targeted Topical Skin Delivery of the Antioxidant Resveratrol
Pharmaceutics 2020, 12(2), 108; https://doi.org/10.3390/pharmaceutics12020108 - 29 Jan 2020
Abstract
Resveratrol (RSV) is a potent lipophilic antioxidant with a low aqueous solubility. Novel nanoformulations have been successfully developed and evaluated to increase the potential of resveratrol as a skin targeting antioxidant. Nanoformulations were prepared using a spontaneous emulsification method, and characterized and evaluated [...] Read more.
Resveratrol (RSV) is a potent lipophilic antioxidant with a low aqueous solubility. Novel nanoformulations have been successfully developed and evaluated to increase the potential of resveratrol as a skin targeting antioxidant. Nanoformulations were prepared using a spontaneous emulsification method, and characterized and evaluated for their capabilities to penetrate/permeate the skin. In nanoformulations, the thermodynamic activity of the RSV penetration into/permeation through the skin was correlated with the thermodynamic activity of the RSV in the formulations. When terpenes were incorporated into the nanoformulations, the permeation of RSV through the skin increased and correlated with an increasing lipophilicity of the terpene. The nanoemulsion containing eugenol showed the highest RSV penetration into the stratum corneum (SC) and the epidermis-dermis-follicle region, whereas the limonene containing nanoemulsion had the highest RSV permeation through the skin (the enhancement ratios, compared to a saturated solution of RSV, were (i) 9.55 and (ii) 12.61, respectively, based on the average RSV amount (i) in each skin region and (ii) permeation through skin). Full article
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Open AccessArticle
Monitoring the Clinical Response to an Innovative Transdermal Delivery System for Ibuprofen
Pharmaceutics 2019, 11(12), 664; https://doi.org/10.3390/pharmaceutics11120664 - 09 Dec 2019
Abstract
We present a phase 1 study that utilizes a crossover design that provides a rapid and relatively inexpensive methodology for evaluating a new transdermal product. The treatment for osteoarthritis (OA) aims to reduce pain and improve function. An innovative magnetophoresis technology has been [...] Read more.
We present a phase 1 study that utilizes a crossover design that provides a rapid and relatively inexpensive methodology for evaluating a new transdermal product. The treatment for osteoarthritis (OA) aims to reduce pain and improve function. An innovative magnetophoresis technology has been developed that facilitates transdermal delivery of ibuprofen. The study used measures that were taken over a relatively short time period to monitor the pharmacodynamic response to ibuprofen. Each participant received magnetophoresis-enhanced transdermal ibuprofen or placebo in randomised order, with a five-day washout period. The participants were 24 volunteers with medically diagnosed, painful knee OA. The primary outcome measures were VAS rating of pain on movement and Western Ontario and McMaster Universities (WOMAC) pain and function scores. VAS for pain on movement (p < 0.001), WOMAC pain score (p = 0.004), and WOMAC function score (p = 0.004) were all significantly improved. There was a significant reduction in movement-related pain (p < 0.05) during the first patch application and for the remainder of the study period. The number needed to treat for a 50% reduction in movement related pain was 2.2. The study showed a rapid and significant analgesic effect in response to transdermal ibuprofen. A short trial of this nature can be used for informing the parameters that are required for a major randomised controlled trial. Full article
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Open AccessArticle
Investigation of Silicone-Containing Semisolid in Situ Film-Forming Systems Using QbD Tools
Pharmaceutics 2019, 11(12), 660; https://doi.org/10.3390/pharmaceutics11120660 - 07 Dec 2019
Abstract
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 [...] Read more.
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. Full article
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Open AccessArticle
Mechanistic Evaluation of Enhanced Curcumin Delivery through Human Skin In Vitro from Optimised Nanoemulsion Formulations Fabricated with Different Penetration Enhancers
Pharmaceutics 2019, 11(12), 639; https://doi.org/10.3390/pharmaceutics11120639 - 01 Dec 2019
Cited by 1
Abstract
Curcumin is a natural product with chemopreventive and other properties that are potentially useful in treating skin diseases, including psoriasis and melanoma. However, because of the excellent barrier function of the stratum corneum and the relatively high lipophilicity of curcumin (log P 3.6), [...] Read more.
Curcumin is a natural product with chemopreventive and other properties that are potentially useful in treating skin diseases, including psoriasis and melanoma. However, because of the excellent barrier function of the stratum corneum and the relatively high lipophilicity of curcumin (log P 3.6), skin delivery of curcumin is challenging. We used the principles of a Quality by Design (QbD) approach to develop nanoemulsion formulations containing biocompatible components, including Labrasol and Lecithin as surfactants and Transcutol and ethanol as cosurfactants, to enhance the skin delivery of curcumin. The nanoemulsions were characterised by cryo-SEM, Zeta potential, droplet size, pH, electrical conductivity (EC) and viscosity (η). Physicochemical long-term stability (6 months) was also investigated. The mean droplet sizes as determined by dynamic light scattering (DLS) were in the lower submicron range (20–50 nm) and the average Zeta potential values were low (range: −0.12 to −2.98 mV). Newtonian flow was suggested for the nanoemulsions investigated, with dynamic viscosity of the nanoemulsion formulations ranging from 5.8 to 31 cP. The droplet size of curcumin loaded formulations remained largely constant over a 6-month storage period. The inclusion of terpenes to further enhance skin permeation was also examined. All nanoemulsions significantly enhanced the permeation of curcumin through heat-separated human epidermal membranes, with the greatest effect being a 28-fold increase in maximum flux (Jmax) achieved with a limonene-based nanoemulsion, compared to a 60% ethanol in water control vehicle. The increases in curcumin flux were associated with increased skin diffusivity. In summary, we demonstrated the effectiveness of nanoemulsions for the skin delivery of the lipophilic active compound curcumin, and elucidated the mechanism of permeation enhancement. These formulations show promise as delivery vehicles for curcumin to target psoriasis and skin cancer, and more broadly for other skin delivery applications. Full article
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