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与生物医学应用、制造工艺及安全方面相关的纳米药物的专利与审批情况

Patented and Approval Scenario of Nanopharmaceuticals with Relevancy to Biomedical Application, Manufacturing Procedure and Safety Aspects.

作者信息

Agarwal Vijay, Bajpai Meenakshi, Sharma Ashish

机构信息

College of Pharmaceutical Sciences, Rajkumar Goel Institute of Technology, 5-Km. Stone, Delhi-Meerut Road, Ghaziabad (U.P.), India.

Institute of pharmaceutical research, G.L.A. University, Mathura-Delhi Road, Mathura (U.P.), India.

出版信息

Recent Pat Drug Deliv Formul. 2018;12(1):40-52. doi: 10.2174/1872211312666180105114644.

DOI:10.2174/1872211312666180105114644
PMID:29303083
Abstract

BACKGROUND

Nanopharmaceutical is the field that arises gradually but many challenges are also still there. This review aims to identify these challenges and give the focus on their rectification.

METHODS

In this paper, we memorize the safety issues, patented manufacturing procedure, applications and regulatory aspects of the nanopharmaceuticals by using the peer-reviewed research literatures. All the screened literatures described the quality content of nanopharmaceuticals with relevancy to biomedical and pharmaceutical field.

RESULTS

Nanopharmaceuticals have great potential to resolve the different issues such as; site specific drug delivery however, many challenges are also arising in their commercialization. In the recent years, some nanopharmaceuticals have the desired quality and safety for the public, have been approved by the regulatory agencies but this field is still a thrust area that demands a lot of attention.

CONCLUSION

The present review article confirms the importance of nanopharmaceuticals and impart the knowledge for making the significant approaches and strategies to overcome the manufacturing, safety, legal and regulatory issues related to nanopharmaceuticals.

摘要

背景

纳米药物是一个逐渐兴起的领域,但仍存在许多挑战。本综述旨在识别这些挑战并重点关注其纠正措施。

方法

在本文中,我们通过使用同行评审的研究文献来记录纳米药物的安全性问题、专利制造工艺、应用和监管方面。所有筛选出的文献都描述了与生物医学和制药领域相关的纳米药物的质量内容。

结果

纳米药物在解决不同问题方面具有巨大潜力,例如靶向给药;然而,它们在商业化过程中也面临许多挑战。近年来,一些纳米药物已具备公众所需的质量和安全性,并已获得监管机构的批准,但该领域仍是一个需要大量关注的重点领域。

结论

本综述文章证实了纳米药物的重要性,并传授了有关制定重要方法和策略以克服与纳米药物相关的制造、安全、法律和监管问题的知识。

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