Development and Evaluation of Dutasteride Nanoemulgel for the Topical Delivery against Androgenic Alopecia.

Q2 Pharmacology, Toxicology and Pharmaceutics Pharmaceutical nanotechnology Pub Date : 2024-01-01 DOI:10.2174/0122117385269151231031161411

Mahboob Alam, Ajit Mishra, Kuldeep Singh Yadav, Deepak Pradhan, Biswakanth Kar, Goutam Ghosh, Goutam Rath, Vineet Kumar Rai

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Abstract

Background: Dutasteride is approximately three times more potent than finasteride in treating alopecia. For reducing systemic exposure to dihydrotestosterone (DHT), researchers have shown special interest in developing topical formulations for treating androgenic alopecia. Dutasteride emulsification may lead to good skin penetration and improved availability in different lipophilic skin environments.

Objectives: This study aimed to encapsulate the drug into the lipidic carrier system for better local availability in the scalp skin, develop and evaluate nanoemulgel of dutasteride to ensure efficient topical administration, and perform the in-vivo activity of the developed gel for improved efficacy against alopecia.

Methods: Dutasteride-loaded nanoemulsion was prepared by a high-speed homogenizer, followed by thickening of the dispersion using Carbopol 934. Skin permeation and accumulation were investigated in the excised skin of male Swiss albino mice. The nanoemulgel was characterized based on pH, stress stability, viscosity, and hardness.

Results: The optimized dutasteride-loaded nanoemulsion had a size of 252.33 ± 8.59 nm, PDI of 0.205 ± 0.60, and drug content of 98.65 ± 1.78%. Stress stability was performed was well observed in nanoemulsion formulation. Nanoemulgel evaluation results were as follows: pH 5-6 was desirable for topical application, hardness was 43 gm, and spreadability was 79 gm with in vitro release of nanoemulgel at 91.98% and permeation study at 13.67%.

Conclusion: The in vivo studies demonstrated the growth of newer hair follicles and increased hair diameter and length in dutasteride-loaded nanoemulgel-treated alopecia animals compared to the marketed sample and testosterone-treated group. Provided with the same and long-term storage stability, the developed formulation is supposed to offer a good option for the topical administration of dutasteride in treating androgenic alopecia.

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杜他雄胺纳米凝胶用于雄激素性脱发局部给药的开发与评估

背景：度他雄胺治疗脱发的效果大约是非那雄胺的三倍。为了减少双氢睾酮（DHT）的全身暴露，研究人员对开发治疗雄激素性脱发的外用制剂表现出特别的兴趣。都他雄胺乳化后可获得良好的皮肤渗透性，并提高在不同亲脂性皮肤环境中的可用性：本研究旨在将药物封装到脂质载体系统中，以提高在头皮皮肤中的局部可用性；开发和评估度他雄胺纳米乳胶，以确保有效的局部给药，并对所开发的凝胶进行体内活性测试，以提高对脱发的疗效：方法：用高速匀浆机制备出含度他雄胺的纳米乳液，然后用Carbopol 934对分散体进行增稠。对雄性瑞士白化小鼠切除皮肤的渗透和蓄积情况进行了研究。根据 pH 值、应力稳定性、粘度和硬度对纳米凝胶进行了表征：优化后的度他雄胺纳米乳液粒径为 252.33 ± 8.59 nm，PDI 为 0.205 ± 0.60，药物含量为 98.65 ± 1.78%。纳米乳剂配方的应力稳定性良好。纳米乳胶的评估结果如下：pH 值为 5-6 适合局部应用，硬度为 43 克，铺展性为 79 克，纳米乳胶的体外释放率为 91.98%，渗透率为 13.67%：体内研究表明，与市场上销售的样品和睾丸素治疗组相比，使用杜他雄胺纳米凝胶治疗脱发症的动物体内毛囊生长速度加快，毛发直径和长度增加。所开发的制剂具有相同的稳定性和长期储存稳定性，可为局部使用度他雄胺治疗雄激素性脱发提供良好的选择。

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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.