Chaudhary Kabi Raj, Viegas Cláudia, Pirela Paola, Atalaia Mariana, Ruivinho Beatriz, Arora Sanchit, Singh Arti, Brandão Pedro, Singh Charan, Fonte Pedro
Department of Pharmaceutics, ISF College of Pharmacy, Moga, Affiliated to IK Gujral Punjab Technical University, Jalandhar, Punjab, 142001, India.
Faculty of Medicine and Biomedical Sciences (FMCB), Universidade do Algarve, Gambelas Campus, 8005-139, Faro, Portugal.
Pharm Res. 2025 Jul 10. doi: 10.1007/s11095-025-03889-1.
Glutathione (GSH), known for having mucolytic, anti-inflammatory, and antioxidant activities, is used in clinical practice in several pathologies, including tuberculosis (TB). N-acetylcysteine (NAC) has been primarily used to treat lung conditions and paracetamol-induced liver toxicity. However, NAC exhibits potential antimycobacterial activity through several mechanisms including immunomodulation, enhancement of GSH levels, and direct antimycobacterial effect. In this work, we aim to develop an effective drug delivery system for NAC for inhalable formulations.
Herein, we report the development of lactose-coated NAC-loaded Poly(lactic-co-glycolic acid) (PLGA) nanoparticles (NAC-PLGA NPs) obtained by double emulsion methodology. Lactose has a double role, as a cryoprotectant agent and dispersant for inhalable formulations. The physicochemical properties of lactose-coated NAC-PLGA NPs were examined in terms of particle size, polydispersity index (PdI), zeta potential (ZP), encapsulation efficiency, and morphology. The in vitro release and lung deposition studies were assessed.
The physicochemical characterization studies revealed the compatibility of the drug with the selected excipients. Moreover, lactose-coated NAC-PLGA NPs showed particle size of 310 ± 3 nm, PdI of 0.15 ± 0.01, and of -11.5 ± 0.4 mV. The in vitro release study suggested a biphasic release profile. Likewise, in vitro lung deposition studies revealed desirable lung deposition parameters, indicating effective particle size for efficient pulmonary delivery. Additionally, in vitro studies for antimycobacterial activity exhibited superior antibacterial activity against Mycobacterium Tuberculosis (MTB) H37Rv.
These preliminary findings suggest that lactose-coated NAC-PLGA NPs can open the door to new therapeutic options against one of the most drug-refractory and drug-resistant infectious diseases, TB.
谷胱甘肽(GSH)具有黏液溶解、抗炎和抗氧化活性,在包括结核病(TB)在内的多种病症的临床实践中得到应用。N-乙酰半胱氨酸(NAC)主要用于治疗肺部疾病和对乙酰氨基酚引起的肝毒性。然而,NAC通过免疫调节、提高GSH水平和直接抗分枝杆菌作用等多种机制表现出潜在的抗分枝杆菌活性。在本研究中,我们旨在开发一种用于NAC的可吸入制剂的有效药物递送系统。
在此,我们报告了通过双乳液法制备的乳糖包衣的载NAC聚乳酸-羟基乙酸共聚物(PLGA)纳米颗粒(NAC-PLGA NPs)的研发情况。乳糖具有双重作用,既是可吸入制剂的冷冻保护剂又是分散剂。从粒径、多分散指数(PdI)、zeta电位(ZP)、包封率和形态等方面对乳糖包衣的NAC-PLGA NPs的理化性质进行了研究。评估了体外释放和肺部沉积研究。
理化特性研究表明药物与所选辅料具有相容性。此外,乳糖包衣的NAC-PLGA NPs的粒径为310±3nm,PdI为0.15±0.01,zeta电位为-11.5±0.4mV。体外释放研究显示出双相释放曲线。同样,体外肺部沉积研究显示出理想的肺部沉积参数,表明粒径适合高效肺部给药。此外,体外抗分枝杆菌活性研究显示对结核分枝杆菌(MTB)H37Rv具有优异的抗菌活性。
这些初步研究结果表明,乳糖包衣的NAC-PLGA NPs可为对抗最具药物难治性和耐药性的传染病之一——结核病开辟新的治疗选择。