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Open AccessArticle

Evaluations of Quality by Design (QbD) Elements Impact for Developing Niosomes as a Promising Topical Drug Delivery Platform

1
Department of Pharmaceutics, Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey, Piscataway, NJ 08855, USA
2
Center for Dermal Research, Life Science Building, Rutgers, The State University of New Jersey, Piscataway, NJ 08854, USA
*
Author to whom correspondence should be addressed.
Pharmaceutics 2020, 12(3), 246; https://doi.org/10.3390/pharmaceutics12030246
Received: 10 January 2020 / Revised: 5 March 2020 / Accepted: 5 March 2020 / Published: 9 March 2020
Topical corticosteroids are used to treat a variety of skin conditions such as allergic reactions, eczema, and psoriasis. Niosomes are a novel surfactant-based delivery system that may be used to deliver desoximetasone via topical product application in order to mitigate common side effects associated with traditional oral delivery routes. The aim of this research was to identify the critical material attributes (CMAs) and critical process parameters (CPPs) that impact key characteristics of drug-loaded niosomes using a systematic quality by design (QbD) approach. An organic phase injection method was developed and used to manufacture the niosomes. The CMAs were identified to be drug amount, concentrations of surfactant and cholesterol, and types of lipids. The CPPs were phase volumes, temperature, mixing parameters, and addition rate based on previous research. The quality attributes measured were entrapment efficiency, particle size distribution, PDI, and zeta potential. These were used to determine the quality target product profile (QTPP) of niosomes. The experimental data indicate that the critical impacting variables for niosomes are: surfactant and cholesterol concentrations, mixing parameters, and organic-phase addition rate. Based on the experimental results of this study methanol:diethyl ether (75:25) as the organic system, drug:surfactant:cholesterol in 1:2:1 concentration, stearic acid as the charge-inducing material, 20 mL external phase and 10 mL internal phase volume, 65 °C external phase temperature, 60 min mixing time, 650 RPM mixing speed and 1 mL/ml addition rate is the ideal combination to achieve desirable desoximetasone niosomes with optimum entrapment efficiency and particle size for topical application. View Full-Text
Keywords: topical drug delivery; niosome; quality by design (QbD),; Critical Material Attributes and Critical Process Parameters (CMA and CPP); desoximetasone; controlled drug delivery; allergic reactions; eczema; psoriasis topical drug delivery; niosome; quality by design (QbD),; Critical Material Attributes and Critical Process Parameters (CMA and CPP); desoximetasone; controlled drug delivery; allergic reactions; eczema; psoriasis
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MDPI and ACS Style

Shah, P.; Goodyear, B.; Haq, A.; Puri, V.; Michniak-Kohn, B. Evaluations of Quality by Design (QbD) Elements Impact for Developing Niosomes as a Promising Topical Drug Delivery Platform. Pharmaceutics 2020, 12, 246.

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