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Pharmaceutical Nanotechnology

Editor-in-Chief

ISSN (Print): 2211-7385
ISSN (Online): 2211-7393

Research Article

Formulation Optimization and Characterization of Tizanidine Hydrochloride-loaded Gold Nanoparticles Using Quality by Design Approach

Author(s): Milind Dharmraj Kamble*, Mahesh Gaikwad, Rajendra Marathe, Mahendra Shirsat and Ganesh Tapadiya

Volume 13, Issue 2, 2025

Published on: 27 April, 2024

Page: [328 - 340] Pages: 13

DOI: 10.2174/0122117385279456240329041704

Price: $65

Abstract

Background: Gold nanoparticles (GNP) have been used extensively in cancer biologics and as drug carrier systems for improved pharmacokinetics and effective therapeutic action. GNPs also ensure reliable diagnosis with sensitive imaging.

Objectives: This study aimed to synthesize tizanidine hydrochloride (TZN)-biodegradable gold (Au) nanoparticles by the reduction of chloroauric acid (HAuCl4) with trisodium citrate using a microwave synthesizer and quality by design approach.

Methods: The formulation method used was optimized using a 32 (two-factor, three-level design) factorial experiment. Temperature (X1) and concentration of gold salt (X2) were the two independent factors, and particle size (Y1), Percent drug entrapment efficiency (Y2), and polydispersity index (Y3) were the responses recorded for the study.

Results: The results of the study revealed that the optimized nanoparticles (TGN8) had a particle size (Y1) of 195 ± 1.2 nm, a polydispersity index of 0.2, and entrapment efficiency of 99.0 ± 2.9% at an optimized concentration of 14 mM gold salt (X1) and 100°C temperature (X2). Atomic Force Microscopy showed the spherical shape particles. In vitro drug release was found to be 62.1 ± 0.5% release of TZN in simulated gastric buffer (pH 1.2) and 45.5 ± 2.8% in physiological buffer (pH 7.4).

Conclusion: Overall, the study identified the optimal formulation conditions for TZN GNPs by considering the effects of independent variables on desired responses.

Keywords: Gold nanoparticles, quality by design, tizanidine, microwave synthesizer, polydispersity, entrapment efficiency

Graphical Abstract
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