基于中央复合设计的盐酸厄洛替尼负载壳聚糖-聚(乳酸-共羟基乙酸)纳米粒子的质量改进型系统配方。

IF 3 Q2 PHARMACOLOGY & PHARMACY Therapeutic delivery Pub Date : 2024-01-01 Epub Date: 2024-05-09 DOI:10.1080/20415990.2024.2342771
Harsh P Nijhawan, Bala Prabhakar, Khushwant S Yadav
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引用次数: 0

摘要

目的:本研究旨在采用质量源于设计(QbD)方法配制盐酸厄洛替尼(ERT-HCL)负载壳聚糖(CS)和聚乳酸-聚乙二醇酸(PLGA)纳米颗粒(NPs),以优化关键质量属性(CQAs)。材料与方法:初步确定了目标产品质量曲线(QTPP)和关键质量属性(CQAs)。在 L8-Taguchi 筛选和风险评估的基础上,采用中心复合设计 (CCD) 优化 NPs。结果负载 ERT-HCL 的 CS-PLGA NPs 的平均粒径、zeta 电位和包埋效率分别为 226.50 ± 1.62 d.nm、27.66 ± 0.64 mV 和 78.93 ± 1.94 %w/w。NPs 呈现出均匀的球形形态,并可持续释放 72 小时:利用系统的 QbD 方法,ERT-HCL 被封装在 CS-PLGA NPs 中,优化了 CQAs。这些发现推动了未来改善 NSCLC 治疗的研究。
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Central composite design augmented quality-by-design-based systematic formulation of erlotinib hydrochloride-loaded chitosan-poly (lactic-co-glycolic acid) nanoparticles.

Aim: This study aimed to formulate erlotinib hydrochloride (ERT-HCL)-loaded chitosan (CS) and poly (lactic-co-glycolic acid) (PLGA) nanoparticles (NPs) using Quality-by-Design (QbD) to optimize critical quality attributes (CQAs). Materials & methods: Quality target product profile (QTPP) and CQAs were initially established. Based on L8-Taguchi screening and risk assessments, central composite design (CCD) design was used to optimize NPs. Results: ERT-HCL-loaded CS-PLGA NPs had a mean particle diameter, zeta potential and entrapment efficiency of 226.50 ± 1.62 d.nm, 27.66 ± 0.64 mV and 78.93 ± 1.94 %w/w, respectively. The NPs exhibited homogenous spherical morphology and sustained release for 72 h. Conclusion: Using systematic QbD approach, ERT-HCL was encapsulated in CS-PLGA NPs, optimizing CQAs. These findings propel future research for improved NSCLC treatment.

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来源期刊
Therapeutic delivery
Therapeutic delivery PHARMACOLOGY & PHARMACY-
CiteScore
5.50
自引率
0.00%
发文量
25
期刊介绍: Delivering therapeutics in a way that is right for the patient - safe, painless, reliable, targeted, efficient and cost effective - is the fundamental aim of scientists working in this area. Correspondingly, this evolving field has already yielded a diversity of delivery methods, including injectors, controlled release formulations, drug eluting implants and transdermal patches. Rapid technological advances and the desire to improve the efficacy and safety profile of existing medications by specific targeting to the site of action, combined with the drive to improve patient compliance, continue to fuel rapid research progress. Furthermore, the emergence of cell-based therapeutics and biopharmaceuticals such as proteins, peptides and nucleotides presents scientists with new and exciting challenges for the application of therapeutic delivery science and technology. Successful delivery strategies increasingly rely upon collaboration across a diversity of fields, including biology, chemistry, pharmacology, nanotechnology, physiology, materials science and engineering. Therapeutic Delivery recognizes the importance of this diverse research platform and encourages the publication of articles that reflect the highly interdisciplinary nature of the field. In a highly competitive industry, Therapeutic Delivery provides the busy researcher with a forum for the rapid publication of original research and critical reviews of all the latest relevant and significant developments, and focuses on how the technological, pharmacological, clinical and physiological aspects come together to successfully deliver modern therapeutics to patients. The journal delivers this essential information in concise, at-a-glance article formats that are readily accessible to the full spectrum of therapeutic delivery researchers.
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