Long-acting intrauterine systems: Recent advances, current challenges, and future opportunities.
Long-acting intrauterine systems: Recent advances, current challenges, and future opportunities.
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DOI：
10.1016/j.addr.2022.114581
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发表时间：
2022-12
影响因子：
16.1
通讯作者：
中科院分区：
文献类型：
--
作者：
左炔诺孕酮宫内系统(LNG-IUS)是一种复杂的药物-装置组合产品，旨在释放一种荷尔蒙避孕药长达7年。这些药物输送系统作为一种现代长效可逆避孕药(LARC)方法提供了巨大的希望，以改善妇女的健康。不幸的是，与这些产品的开发相关的一些科学挑战是导致市场上相对较少的IUS产品的主要原因之一。本文综述了宫内节育器的处方考虑(药物和赋形剂属性)、制造方法、表征和体外释药试验的进展，以及影响宫内节育器药物释放的因素。对IUS产品开发面临的主要挑战进行了关键的讨论。具体地说，在生物等效性评价、体外-体内相关性(IVIVC)建立和监管挑战方面的见解被详细介绍。最后，提出了克服这些产品开发障碍的方法论工具。通过审查提供的知识将有助于更好地了解产品。这样的理解将有助于这些复杂药物产品的开发，以及它们的监管审批过程。
Levonorgestrel intrauterine systems (LNG-IUSs) are complex drug-device combination products designed to release a hormonal contraceptive drug for up to 7 years. These drug delivery systems offers a great promise as a modern method of long-acting reversible contraceptives (LARCs) to improve women’s health. Unfortunately, there are some scientific challenges associated with the development of these products which are among the major reasons contributing to the availability of relatively few IUS products on the market. This review summarizes the formulation considerations (drug and excipient attributes), manufacturing methods, advances in characterization and in vitro drug release testing of IUSs, as well as factors influencing drug release from IUSs. A critical discussion on the major challenges to IUS product development is presented. Specifically, insights on bioequivalence evaluation, in vitro-in vivo correlation (IVIVC) establishment, and regulatory challenges are detailed. Lastly, methodological tools to overcome some of these hurdles to product development are proposed. The knowledge furnished through this review will be helpful towards obtaining better product understanding. Such understanding will facilitate the development of these complex drug products, as well as their regulatory approval process.
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影响因子：
5.8
作者：
Bao Q;Gu B;Price CF;Zou Y;Wang Y;Kozak D;Choi S;Burgess DJ
通讯作者：
Burgess DJ
影响因子：
5.8
作者：
Bao Q;Zou Y;Wang Y;Choi S;Burgess DJ
通讯作者：
Burgess DJ
DOI：
10.1097/01.naj.0000654304.29632.a7
发表时间：
2020-02
期刊：
The American journal of nursing
影响因子：
--
作者：
Britton LE;Alspaugh A;Greene MZ;McLemore MR
通讯作者：
McLemore MR
影响因子：
5.6
作者：
Bhatt N;Deshpande M
通讯作者：
Deshpande M
影响因子：
2.9
作者：
ANDERSSON, K;ODLIND, V;RYBO, G
通讯作者：
RYBO, G