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

Abstract

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.

Formulation and characterization of propolis and tea tree oil nanoemulsion loaded with clindamycin hydrochloride for wound healing: In-vitro and in-vivo wound healing assessment

“…There was no significant difference between GP (3) and GP (4) at all time intervals revealing that TTO exerted comparable antimicrobial efficacy to clindamycin hydrochloride against skin transient flora. These results agree with Muta et al (2020) , who found that TTO lipid-based nanoformulation (5% TTO) exhibited bitter antibacterial activity against S. epidermidis than kanamycin.

Fig.

…”

Solid Self-Nano Emulsifying Nanoplatform Loaded with Tamoxifen and Resveratrol for Treatment of Breast Cancer

“…The instrument works on the principle of dynamic light scattering (DLS). s-SNEDDS of 100 mg were diluted with 90 mL of deionized water, sonicated for 50 s and left undisturbed for 2 h. Then, the evaluation of droplet size and PDI of the collected samples was performed at 25 ± 2 °C with a constant refractive index of 1.471 [ 40 ]. All the observations were carried out in triplicate.…”

“…A UV spectrophotometer was used to determine the percentage of transmittance of the s-SNEDDS. Then, 100 mg of s-SNEDDS were diluted with 90 mL of deionized water, sonicated for 50 s and left undisturbed for 2 h. Next, the percentage of transmittance of the samples were measured at 510 nm with deionized water as blank [ 40 ]. All the observations were carried out in triplicate.…”

“…A single drop of reconstituted sample was placed on a 200 mesh carbon coated grid and then stained with 2% uranyl acetate. After drying, the grid with stained samples was visualized under TEM (FEI Company, USA) at an accelerating voltage of 100 KV [ 40 ].…”

Nanoemulsification Improves the Pharmaceutical Properties and Bioactivities of Niaouli Essential Oil (Melaleuca quinquenervia L.)

“…NEO has been investigated as a permeation enhancer for transdermal and cutaneous drug delivery of estradiol via gel formulations [18,19]. Various topical NE-based formulations of similar essential oils, such as tea tree oil, have been investigated for biological evaluation [20][21][22][23]. Topical NEs of other essential oils, such as eucalyptus essential oil, celery essential oil, psoralen, lemongrass essential oil, and babchi essential oil, have also been studied in the literature [12,[24][25][26][27][28].…”