Title:Formulation Optimization and Characterization of Tizanidine Hydrochloride-loaded Gold Nanoparticles Using Quality by Design Approach
Volume: 13
Issue: 2
Author(s): Milind Dharmraj Kamble*, Mahesh Gaikwad, Rajendra Marathe, Mahendra Shirsat and Ganesh Tapadiya
Affiliation:
- Department of Pharmaceutics & Biopharmaceutics, Shreeyash Institute of Pharmaceutical Education & Research,
Aurangabad, Gut No. 258, Behind SRPF Camp, Satara Parisar Aurangabad, India
Keywords:
Gold nanoparticles, quality by design, tizanidine, microwave synthesizer, polydispersity, entrapment efficiency
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.