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

Q2 Pharmacology, Toxicology and Pharmaceutics

Pharmaceutical nanotechnology Pub Date : 2024-04-27 DOI:10.2174/0122117385279456240329041704

Milind Dharmraj Kamble, Mahesh Gaikwad, Rajendra Marathe, Mahendra Shirsat, Ganesh Tapadiya

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引用次数: 0

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.

Objective: 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.

Result: 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 0C 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.

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采用质量设计法优化盐酸替扎尼定负载金纳米粒子的配方并确定其特性

背景：金纳米粒子（GNP）已被广泛应用于癌症生物制剂和药物载体系统，以改善药代动力学和有效的治疗作用。GNP 还能通过灵敏的成像确保可靠的诊断：本研究旨在利用微波合成器和质量设计法，通过柠檬酸三钠还原氯尿酸（HAuCl4）合成盐酸替扎尼定（TZN）-生物可降解金（Au）纳米粒子：采用 32（两因素、三层次设计）因子实验对所使用的配方方法进行了优化。温度（X1）和金盐浓度（X2）是两个独立因素，粒度（Y1）、药物夹带效率百分比（Y2）和多分散指数（Y3）是研究记录的响应：研究结果表明，在 14 mM 金盐（X1）和 100 0C 温度（X2）的优化浓度下，优化纳米粒子（TGN8）的粒径（Y1）为 195 ± 1.2 nm，多分散指数为 0.2，药物夹带效率为 99.0 ± 2.9%。原子力显微镜显示颗粒呈球形。体外药物释放结果表明，TZN 在模拟胃缓冲液（pH 值为 1.2）中的释放率为 62.1 ± 0.5%，在生理缓冲液（pH 值为 7.4）中的释放率为 45.5 ± 2.8%：总之，该研究通过考虑独立变量对预期反应的影响，确定了 TZN GNPs 的最佳配制条件。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmaceutical nanotechnology Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science

CiteScore

4.20

自引率

0.00%

发文量

期刊介绍： Pharmaceutical Nanotechnology publishes original manuscripts, full-length/mini reviews, thematic issues, rapid technical notes and commentaries that provide insights into the synthesis, characterisation and pharmaceutical (or diagnostic) application of materials at the nanoscale. The nanoscale is defined as a size range of below 1 µm. Scientific findings related to micro and macro systems with functionality residing within features defined at the nanoscale are also within the scope of the journal. Manuscripts detailing the synthesis, exhaustive characterisation, biological evaluation, clinical testing and/ or toxicological assessment of nanomaterials are of particular interest to the journal’s readership. Articles should be self contained, centred around a well founded hypothesis and should aim to showcase the pharmaceutical/ diagnostic implications of the nanotechnology approach. Manuscripts should aim, wherever possible, to demonstrate the in vivo impact of any nanotechnological intervention. As reducing a material to the nanoscale is capable of fundamentally altering the material’s properties, the journal’s readership is particularly interested in new characterisation techniques and the advanced properties that originate from this size reduction. Both bottom up and top down approaches to the realisation of nanomaterials lie within the scope of the journal.