Design and evaluation of microemulsion-based efinaconazole formulations for targeted treatment of onychomycosis through transungual route: Ex vivo and nail clipping studies

Agrawal, Vikas; Patel, Rajesh; Mrunali, Patel; Thanki, Kaushik; Mishra, Susmita

doi:10.1016/j.colsurfb.2021.111652

Cited by 22 publications

(14 citation statements)

References 29 publications

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“…Encapsulation efficiency was analyzed by the validated RP-HPLC method reported earlier with slight modification [ 22 , 23 ]. The RP-HPLC analysis was carried out at 22 °C (Jasco PU-2080 Plus, Intelligent HPLC pump, Japan, Detector of Jasco 2075, Intelligent UV–vis detector, Jasco, Tokyo, Japan, and RP-C18 column of Agilent, 250 × 4.6 mm, 5 μm particle size, Technologies, Mumbai, India).…”

Section: Methodsmentioning

confidence: 99%

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Formulation-by-Design of Efinaconazole Spanlastic Nanovesicles for Transungual Delivery Using Statistical Risk Management and Multivariate Analytical Techniques

2022

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As regulatory and technical landscapes for pharmaceutical formulation development are rapidly evolving, a risk-management approach using multivariate analysis is highly essential for designing a product with requisite critical quality attributes (CQA). Efinaconazole, a newly approved poorly water-soluble antifungal triazole drug has poor permeability. Spanlastics, new-generation surfactant nanovesicles, being fluidic, help improve the permeability of drugs. Therefore, we optimized efinaconazole spanlastics using the concepts of Formulation-by-Design (FbD) and explored the feasibility of transungual delivery for the management of onychomycosis. Using the Ishikawa fishbone diagram, the risk factors that may have an impact on the CQA of efinaconazole spanlastic vesicles were identified. Application of the Plackett–Burman experimental design facilitated the screening of eight different formulation and process parameters influencing particle size, transmittance, relative deformability, zeta potential, entrapment efficiency, and dissolution efficiency. With the help of Pareto charts, the three most significant factors were identified, viz., vesicle builder (Span), edge activator (Tween), and mixing time. The levels of these three critical variables were optimized by FbD to reduce the particle size and maximize the transparency, relative deformability, encapsulation efficiency, and dissolution efficiency of efinaconazole spanlastic nanovesicles. Bayesian and Lenth’s analysis and mathematical modeling of the experimental data helped to quantify the critical formulation attributes required for getting the formulation with optimum quality features. The optimized efinaconazole-loaded spanlastic vesicles had a particle size of 197 nm, transparency of 91%, relative deformability of 12.5 min, and dissolution efficiency of 81.23%. The spanlastic formulation was incorporated into a gel and explored ex vivo for transungual delivery. This explorative study provides an example of the application of principles of risk management, statistical multivariate analysis, and the FbD approach in developing efinaconazole spanlastic nanovesicles.

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Section: Methodsmentioning

confidence: 99%

“…20 μL of each sample was injected after suitable dilution with mobile phase and detected at 210 nm. The mobile phase consisted of phosphate buffer pH 5.5 and acetonitrile (25:75), and an isocratic flow of 1 mL/min was used [ 23 ].…”

Section: Methodsmentioning

confidence: 99%

Formulation-by-Design of Efinaconazole Spanlastic Nanovesicles for Transungual Delivery Using Statistical Risk Management and Multivariate Analytical Techniques

2022

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“…Bu veri, yağ globülü yüzeyinde iyonik olmayan yüzey etkin maddenin herhangi bir önemli yük (> ± 30 mV) oluşturmadığını göstermiştir. 8,31 Mikroemülsiyon sistemlerin reolojik davranışı genellikle Newton akış modeline uygun olduğu bilinmektedir. Mikroemülsiyon sistemler iç fazlarının küçük damlacık boyutuna sahip olmaları sebebi ile tek fazlı bir sistem gibi davranıp, kayma hızına ve gerilime bağlı olmaksızın doğrusal bir akış özelliği göstermektedir.…”

Section: Discussionunclassified

Calendula officinalis L. bitkisinin morfolojik özellikleri, ekstre içeren topikal ilaç formülasyonu geliştirilmesi ve in vitro değerlendirilmesi

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et al. 2022

Mersin Üniversitesi Tıp Fakültesi Lokman Hekim Tıp Tarihi Ve Folklorik Tıp Dergisi

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Amaç: Çalışmamızda Calendula officinalis'in morfolojik değerlendirmesi ve geleneksel kullanımları verilmiştir. Hazırlanan Calendula officinalis ekstresinin topikal uygulabilmesi için taşıyıcı olarak kullanılabilecek mikroemülsiyon geliştirmesi amaçlanmıştır. Yöntem: Calendula officinalis'in bitki örnekleri botanik bahçesinden toplanmış ve herbaryuma yerleştirilmiştir. Üçgen faz diyagramları, yağ ve farklı oranlarda farklı yüzey aktif madde/yardımcı yüzey aktif maddenin kombinasyonları kullanılarak hazırlanıştır. Seçilen mikroemülsiyonların daha sonra damlacık boyutu, polidispersite indeksi, pH, zeta potansiyeli ve reoloji açısından karakterizasyonları yapılmıştır.

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“…Nano-and microemulsions have been described as ideal carriers for the delivery of drugs via many administration routes, including oral, pulmonary, ocular, and parenteral [68][69][70].…”

Section: Nano-and Microemulsionsmentioning

confidence: 99%

Application of Lipid-Based Nanocarriers for Antitubercular Drug Delivery: A Review

et al. 2021

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The antimicrobial drugs currently used for the management of tuberculosis (TB) exhibit poor bioavailability that necessitates prolonged treatment regimens and high dosing frequency to achieve optimal therapeutic outcomes. In addition, these agents cause severe adverse effects, as well as having detrimental interactions with other drugs used in the treatment of comorbid conditions such as HIV/AIDS. The challenges associated with the current TB regimens contribute to low levels of patient adherence and, consequently, the development of multidrug-resistant TB strains. This has led to the urgent need to develop newer drug delivery systems to improve the treatment of TB. Targeted drug delivery systems provide higher drug concentrations at the infection site, thus leading to reduced incidences of adverse effects. Lipid-based nanocarriers have proven to be effective in improving the solubility and bioavailability of antimicrobials whilst decreasing the incidence of adverse effects through targeted delivery. The potential application of lipid-based carriers such as liposomes, niosomes, solid lipid nanoparticles, nanostructured lipid carriers, nano and microemulsions, and self-emulsifying drug delivery systems for the treatment of TB is reviewed herein. The composition of the investigated lipid-based carriers, their characteristics, and their influence on bioavailability, toxicity, and sustained drug delivery are also discussed. Overall, lipid-based systems have shown great promise in anti-TB drug delivery applications. The summary of the reviewed data encourages future efforts to boost the translational development of lipid-based nanocarriers to improve TB therapy.

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Design and evaluation of microemulsion-based efinaconazole formulations for targeted treatment of onychomycosis through transungual route: Ex vivo and nail clipping studies

Cited by 22 publications

References 29 publications

Formulation-by-Design of Efinaconazole Spanlastic Nanovesicles for Transungual Delivery Using Statistical Risk Management and Multivariate Analytical Techniques

Formulation-by-Design of Efinaconazole Spanlastic Nanovesicles for Transungual Delivery Using Statistical Risk Management and Multivariate Analytical Techniques

Calendula officinalis L. bitkisinin morfolojik özellikleri, ekstre içeren topikal ilaç formülasyonu geliştirilmesi ve in vitro değerlendirilmesi

Application of Lipid-Based Nanocarriers for Antitubercular Drug Delivery: A Review

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