Development, optimization, and characterization of a novel tea tree oil nanogel using response surface methodology

Sinha, Priyam; Srivastava, Shruti; Mishra, Nidhi; Singh, Dhananjay Kumar; Luqman, Suaib; Chanda, Debabrata; Yadav, Narayan Prasad

doi:10.3109/03639045.2016.1141931

Cited by 44 publications

(28 citation statements)

References 43 publications

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“…TTO incorporated in nanocapsules has been reported in the literature [13][14][15]. However, the major drawbacks of the reported formulations are the presence of harsh solvents and chemicals that could potentially cause adverse effects, which is consistent with the USP <467> requirements [14,16].…”

Section: Introductionmentioning

confidence: 59%

“…However, the major drawbacks of the reported formulations are the presence of harsh solvents and chemicals that could potentially cause adverse effects, which is consistent with the USP <467> requirements [14,16]. Furthermore, the existing research uses the concentration of excipients beyond the limit specified by regulatory agencies such as US Food and Drug Administration for topical use [13][14][15]. Thus, the commercial translation of other reported topical formulations loaded with TTO is not possible [14,15,[17][18][19].…”

Section: Introductionmentioning

confidence: 99%

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Quality-by-Design Approach for the Development of Nano-Sized Tea Tree Oil Formulation-Impregnated Biocompatible Gel with Antimicrobial Properties

et al. 2020

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Despite the promising properties of tea tree oil (TTO) as potential therapeutics for several superficial skin conditions, certain limitations such as physical instability and skin irritation have restricted its widespread use. This study focuses on developing a rationally designed lipid-based nanoformulation (TTO-LNF) in accordance with the US Food and Drug Administration standard using a well-recognized quality-by-design (QbD) approach. Using a mixture experimental design, TTO-LNF has been optimized with 5% TTO, 10% surfactant, 5% co-surfactant, and 80% water, which showed a 14.4 ± 4.4 nm droplet size and 0.03 ± 0.01 polydispersity index (PDI). To ease the topical administration, the TTO-LNF gel formulation was further developed using xanthan gum to achieve the desired viscosity and form a gel. The in vitro antibacterial tests of TTO-LNF showed promising inhibitory effects toward both Gram-negative and Gram-positive bacteria. In fact, a complete growth inhibition of S. epidermidis was observed when exposed to TTO-LNF and TTO-LNF gel for 24 h, showing better activity than antibiotic kanamycin (25 µg/mL). Additionally, the in vitro release study showed a sustained release profile with a 50% release in 24 h, which could be beneficial to reduce the toxicity and thereby improve the therapeutic efficacy for long-acting applications. Furthermore, the formulations were remarkably stable at 40 °C/75% Relative humidity (RH) for at least 4 weeks. Therefore, this study presents a promising strategy to develop a biocompatible and stable formulation that can be used for the topical treatment of skin infections.

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Section: Introductionmentioning

confidence: 59%

Section: Introductionmentioning

confidence: 99%

Quality-by-Design Approach for the Development of Nano-Sized Tea Tree Oil Formulation-Impregnated Biocompatible Gel with Antimicrobial Properties

et al. 2020

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“…The results showed that the nanoemulsions successfully facilitated the delivery of the extract through the SC. In addition, the hydrophilic part of nanoemulsions can hydrate the SC probably facilitating skin uptake of the compound [40]. Our findings suggested that the evolved nanoemulsions could successfully improve stability and skin permeability of M. indica kernel extract, which might provide better outcomes for topical anti-acne applications.…”

Section: Discussionmentioning

confidence: 75%

Optimization of Mangifera indica L. Kernel Extract-Loaded Nanoemulsions via Response Surface Methodology, Characterization, Stability, and Skin Permeation for Anti-Acne Cosmeceutical Application

et al. 2020

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This study aimed to optimize nanoemulsions loading with Mangifera indica L. kernel extract using response surface methodology for enhancing the stability and skin permeation of the extract. Central composite design was employed for optimization and evaluation of three influencing factors including hydrophile-lipophile balance (HLB), % co-surfactant (PEG-7 glyceryl cocoate), and surfactant-to-oil ratio (SOR) on physical properties of the nanoemulsions. The desired nanoemulsions were then incorporated with the extract and characterized. Physicochemical properties of the extract-loaded nanoemulsions and their antibacterial effects against Propionibacterium acnes were also evaluated after storage at various conditions and compared to those of the initial. Ex vivo skin permeation was also investigated. The factors significantly (p < 0.05) influenced on droplet size, polydispersity index (PDI), and zeta potential, especially HLB of the surfactant and its combined effects with co-surfactant and SOR. The extract-loaded nanoemulsions revealed a very small spherical droplets (size of 26.14 ± 0.22 nm) with narrow size distribution (PDI of 0.16 ± 0.02). The formulation also presented an excellent stability profile and successfully enhanced antibacterial stability of the extract comparing with the extract solution. Ex vivo skin permeation study illustrated that the extract in nanoemulsions could be delivered through a primary skin barrier to reach viable epidermis dermis layers. In conclusion, the affinity of surfactant and hydrophilicity of the system play a crucial role in nanoemulsions’ characteristics. Such results might provide promising anti-acne nanoemulsions with the notable capacities of extract stabilization and permeation enhancing which will be further clinically evaluated.

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“…To the best of the authorsʼ knowledge, only a few studies are available on TTO permeation [11][12][13], with all of them investigating markers accumulated in the skin by solvent extraction. In 2006, Reichling et al [7] compared several formulations and studied the permeation of the major TTO component, i.e., 4-terpineol, without measuring its distribution in the skin layers.…”

Section: Melaleuca Alternifolia Essential Oil: Evaluation Of Skin Permentioning

confidence: 99%

Melaleuca alternifolia Essential Oil: Evaluation of Skin Permeation and Distribution from Topical Formulations with a Solvent-Free Analytical Method

et al. 2020

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Melaleuca alternifolia essential oil (tea tree oil) is widely used as an ingredient in skin care products because of its recognized biological activities. The European Scientific Committee on Consumer Products constantly promotes research and collection of data on both skin distribution and systemic exposure to tea tree oil components after the application of topical formulations. This study quantitatively evaluates permeation, skin layer distribution (stratum corneum, epidermis, and dermis), and release into the surrounding environment of bioactive tea tree oil markers (i.e., α-pinene, β-pinene, α-terpinene, 1,8-cineole, γ-terpinene, 4-terpineol, α-terpineol) when a 5% tea tree oil formulation is applied at a finite dosing regimen. Permeation kinetics were studied in vitro on pig ear skin using conventional static glass Franz diffusion cells and cells ad hoc modified to monitor the release of markers into the atmosphere. Formulation, receiving phases, and skin layers were analyzed using a fully automatic and solvent-free method based on headspace solid-phase microextraction/gas chromatography-mass spectrometry. This approach affords, for the first time, to quantify tea tree oil markers in the different skin layers while avoiding using solvents and overcoming the existing methods based on solvent extraction. The skin layers contained less than 1% of each tea tree oil marker in total. Only oxygenated terpenes significantly permeated across the skin, while hydrocarbons were only absorbed at trace level. Substantial amounts of markers were released into the atmosphere.

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Development, optimization, and characterization of a novel tea tree oil nanogel using response surface methodology

Abstract: TTO EG turned out to be a promising vehicle for the topical delivery of TTO with enhanced therapeutic efficacy.

Cited by 44 publications

References 43 publications

Quality-by-Design Approach for the Development of Nano-Sized Tea Tree Oil Formulation-Impregnated Biocompatible Gel with Antimicrobial Properties

Quality-by-Design Approach for the Development of Nano-Sized Tea Tree Oil Formulation-Impregnated Biocompatible Gel with Antimicrobial Properties

Optimization of Mangifera indica L. Kernel Extract-Loaded Nanoemulsions via Response Surface Methodology, Characterization, Stability, and Skin Permeation for Anti-Acne Cosmeceutical Application

Melaleuca alternifolia Essential Oil: Evaluation of Skin Permeation and Distribution from Topical Formulations with a Solvent-Free Analytical Method

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