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Article

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

1
Pharmaceutical Innovation and Development Group (PIDG), UniSA Clinical & Health Science, University of South Australia, City West Campus, North Terrace, Adelaide, SA 5000, Australia
2
Faculty of Health, University of Canberra, Canberra, ACT 2617, Australia
*
Author to whom correspondence should be addressed.
These authors contributed equally to this work.
Pharmaceutics 2020, 12(11), 1091; https://doi.org/10.3390/pharmaceutics12111091
Received: 9 October 2020 / Revised: 5 November 2020 / Accepted: 7 November 2020 / Published: 13 November 2020
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. View Full-Text
Keywords: tea tree oil; lipid-based nanotechnology; topical drug delivery; quality by design; mixture experimental design; controlled release; accelerated stability assessment; anti-microbial activity; Staphylococcus epidermidis; Pseudomonas aeruginosa tea tree oil; lipid-based nanotechnology; topical drug delivery; quality by design; mixture experimental design; controlled release; accelerated stability assessment; anti-microbial activity; Staphylococcus epidermidis; Pseudomonas aeruginosa
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MDPI and ACS Style

Muta, T.; Parikh, A.; Kathawala, K.; Haidari, H.; Song, Y.; Thomas, J.; Garg, S. Quality-by-Design Approach for the Development of Nano-Sized Tea Tree Oil Formulation-Impregnated Biocompatible Gel with Antimicrobial Properties. Pharmaceutics 2020, 12, 1091. https://doi.org/10.3390/pharmaceutics12111091

AMA Style

Muta T, Parikh A, Kathawala K, Haidari H, Song Y, Thomas J, Garg S. Quality-by-Design Approach for the Development of Nano-Sized Tea Tree Oil Formulation-Impregnated Biocompatible Gel with Antimicrobial Properties. Pharmaceutics. 2020; 12(11):1091. https://doi.org/10.3390/pharmaceutics12111091

Chicago/Turabian Style

Muta, Thabata, Ankit Parikh, Krishna Kathawala, Hanif Haidari, Yunmei Song, Jackson Thomas, and Sanjay Garg. 2020. "Quality-by-Design Approach for the Development of Nano-Sized Tea Tree Oil Formulation-Impregnated Biocompatible Gel with Antimicrobial Properties" Pharmaceutics 12, no. 11: 1091. https://doi.org/10.3390/pharmaceutics12111091

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