Quality by design (QbD) approach-based development of optimized nanocarrier to achieve quality target product profile (QTPP)-targeted lymphatic delivery

材料科学 关键质量属性 设计质量 甘露糖受体 纳米载体 纳米技术 药物输送 粒径 化学 生物化学 体外 巨噬细胞 物理化学
作者
Rahul Maurya,Suman Ramteke,N. K. Jain
出处
期刊:Nanotechnology [IOP Publishing]
卷期号:35 (26): 265101-265101 被引量:1
标识
DOI:10.1088/1361-6528/ad355b
摘要

Abstract Background. Insulin, commonly used for diabetes treatment, needs better ways to improve its effectiveness and safety due to its challenges with poor permeability and stability. Various system has been developed for oral peptide delivery. The non-targeted system can prevent gastric and enzymatic degradation of peptides but cannot increase the bulk transport of peptides across the membrane. However, the non-selectivity is the limitation of the existing system. Numerous carbohydrate-binding receptors overexpressed on intestinal macrophage cells (M-cells) of gut-associated lymphoid tissue. It is the most desirable site for receptor-mediated endocytosis and lymphatic drug delivery of peptides. Objective . The prime objective of the study was to fabricate mannose ligand conjugated nanoparticles (MNPs) employing a quality-by-design approach to address permeability challenges after oral administration. Herein, the study’s secondary objective of this study is to identify the influencing factor for producing quality products. Considering this objective, the Lymphatic uptake of NPs was selected as a quality target product profile (QTPP), and a systematic study was conducted to identify the critical formulation attributes (CFAs) and critical process parameters (CPP) influencing critical quality attributes (CQAs). Mannosylated Chitosan concentrations (MCs) and TPP concentrations were identified as CFAs, and stirring speed was identified as CPP. Methods . MNPs were prepared by the inotropic gelation method and filled into the enteric-coated capsule to protect from acidic environments. The effect of CFAs and CPP on responses like particle size ( X ) and entrapment ( Y ) was observed by Box-Behnken design (BBD). ANOVA statistically evaluated the result to confirm a significant level ( p < 0.05). The optimal conditions of NPs were obtained by constructing an overlay plot and determining the desirability value. HPLC and zeta-seizer analysis characterized the lyophilized NPs. Cell-line studies were performed to confirm the safety and M-cell targeting of NPs to enhance Insulin oral bioavailability. Results . The morphology of NPs was revealed by SEM. The developed NPs showed a nearly oval shape with the average size, surface potential, and % drug entrapment were 245.52 ± 3.37 nm, 22.12 ± 2.13 mV, and 76.15 ± 1.3%, respectively. MTT assay result exhibited that MNPs safe and Confocal imaging inference that NPs selectively uptake by the M-cell. Conclusion . BBD experimental design enables the effective formulation of optimized NPs. The statistical analysis estimated a clear assessment of the significance of the process and formulation variable. Cell line study confirms that NPs are safe and effectively uptake by the cell.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
栗子完成签到,获得积分20
1秒前
脑洞疼应助梨梨梨采纳,获得10
2秒前
许可媛完成签到,获得积分10
2秒前
3秒前
3秒前
啊啊发布了新的文献求助10
3秒前
量子星尘发布了新的文献求助10
4秒前
4秒前
科研通AI5应助zzd采纳,获得10
4秒前
只因关注了科研通微信公众号
7秒前
Owen应助翁雁丝采纳,获得10
7秒前
7秒前
许安发布了新的文献求助10
8秒前
8秒前
Dyson发布了新的文献求助30
9秒前
9秒前
丘比特应助科研通管家采纳,获得30
10秒前
10秒前
上官若男应助科研通管家采纳,获得10
10秒前
10秒前
11秒前
11秒前
11秒前
shinysparrow应助科研通管家采纳,获得200
11秒前
guogangyouming完成签到,获得积分10
11秒前
明亮的如曼完成签到,获得积分10
12秒前
迷你的靖雁完成签到,获得积分10
12秒前
zhaxiao发布了新的文献求助10
12秒前
13秒前
栗子发布了新的文献求助10
14秒前
搜集达人应助陈博文采纳,获得10
15秒前
喜悦落雁完成签到 ,获得积分20
18秒前
孤僻完成签到,获得积分10
19秒前
19秒前
21秒前
22秒前
22秒前
英姑应助白小白采纳,获得10
22秒前
ahey完成签到,获得积分10
22秒前
无花果应助淡淡向日葵采纳,获得10
24秒前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
Picture Books with Same-sex Parented Families: Unintentional Censorship 700
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
Nucleophilic substitution in azasydnone-modified dinitroanisoles 500
不知道标题是什么 500
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3975693
求助须知:如何正确求助?哪些是违规求助? 3520019
关于积分的说明 11200635
捐赠科研通 3256410
什么是DOI,文献DOI怎么找? 1798255
邀请新用户注册赠送积分活动 877490
科研通“疑难数据库(出版商)”最低求助积分说明 806390