Assessment of therapeutic effectiveness of developed colchicine transnovasomes in treatment of recurrent aphthous ulcer as monotherapy and combination therapy with platelet-rich plasma.

IF 2.6 4区医学 Q2 PHARMACOLOGY & PHARMACY

Pharmaceutical Development and Technology Pub Date : 2025-03-01 Epub Date: 2025-03-10 DOI:10.1080/10837450.2025.2475967

Soha M Kandil, Iman I Soliman, Marwa Hosni, Abeer Salama, Ebtisam M Abdou

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引用次数: 0

Abstract

Objectives: Transnovasomes is a new exciting class of lipid-based nanovesicles. Colchicine (COL) is a hydrophilic natural alkaloid with anti-inflammatory features having oral administration and permeation defects. Recurrent Aphthous Ulcer (RAU) is the most prevalent disease of the oral mucosa suffering from lack of a particular and final preventative therapy. So, designing a prolonged and effective specialized delivery system for ulcer treatment is important.

Methods: Colchicine transnovasomes (COL-TNs) were prepared using surfactants (Span 60 & Span 80), free fatty acids (Oleic acid & Stearic acid), Cholesterol and Brij 58. COL-TNs were evaluated for their vesicle size (VS), polydispersity index (PDI), zeta potential (ZP), entrapment efficiency (EE%), and ex-vivo permeation after 12 h (Q_12h).

Results: Values of VS, PDI, ZP, EE% and Q_12h of the optimized formulation were 256.74 ± 11.2 nm, 0.322 ± 0.08, -43.3 ± 0.62, 85.35 ± 3.7% and 72.69 ± 5.84% respectively. Drug accumulation from the optimized formulation was ninefold greater than drug solution after 8 h. In-vivo, COL-TNs formulation, alone or in combination with platelet-rich plasma (PRP), achieved complete healing of acetic-acid induced RAU restoring normal levels of assayed biomarkers and normal oral mucosa histological features.

Conclusions: COL-TNs can be used as a promising, safe, efficient treatment of RAU, as monotherapy or combination therapy with PRP.

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秋水仙碱转新酶体单药与富血小板血浆联合治疗复发性阿弗特溃疡的疗效评价。

外泌体是一类新的、令人兴奋的基于脂质的纳米囊泡。秋水仙碱（COL）是一种亲水性天然生物碱，具有抗炎和抗有丝分裂的特性，但有口服给药和渗透缺陷。复发性口腔溃疡（RAU）是口腔黏膜最常见的疾病，缺乏一种特殊的和最终的预防性治疗。因此，设计一个长期有效的专门给药系统治疗溃疡是很重要的。采用表面活性剂（Span 60和Span 80）、游离脂肪酸（油酸和硬脂酸）、胆固醇和brij58制备了秋水仙碱转novassomes （COL-TNs）。对制备的col - tn进行囊泡大小（VS）、多分散性指数（PDI）、ζ电位（ZP）、包封效率（EE%）和12h后的离体透性（Q12h）评价。优化处方的VS、PDI、ZP、EE%和Q12h分别为256.74±11.2 nm、0.322±0.08、-43.3±0.62、85.35±3.7%和72.69±5.84%。8 h后，其药物积累量是原液的9倍。在体内，COL-TNs制剂，单独或联合富血小板血浆（PRP），实现醋酸诱导的RAU完全愈合，恢复了测定的生物标志物（TNF- α, NF-κβ, IL-6, MMP9， VEGF）的正常水平和口腔黏膜的正常组织学特征。综上所述，COL-TNs可作为RAU的一种有前景、安全、有效的治疗方法，可单独或联合PRP治疗。

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 Development and Technology 医学-药学

CiteScore

5.90

自引率

2.90%

发文量

审稿时长

1 months

期刊介绍： Pharmaceutical Development & Technology publishes research on the design, development, manufacture, and evaluation of conventional and novel drug delivery systems, emphasizing practical solutions and applications to theoretical and research-based problems. The journal aims to publish significant, innovative and original research to advance the frontiers of pharmaceutical development and technology. Through original articles, reviews (where prior discussion with the EIC is encouraged), short reports, book reviews and technical notes, Pharmaceutical Development & Technology covers aspects such as: -Preformulation and pharmaceutical formulation studies -Pharmaceutical materials selection and characterization -Pharmaceutical process development, engineering, scale-up and industrialisation, and process validation -QbD in the form a risk assessment and DoE driven approaches -Design of dosage forms and drug delivery systems -Emerging pharmaceutical formulation and drug delivery technologies with a focus on personalised therapies -Drug delivery systems research and quality improvement -Pharmaceutical regulatory affairs This journal will not consider for publication manuscripts focusing purely on clinical evaluations, botanicals, or animal models.