Just how prevalent are peptide therapeutic products? A critical review.
Just how prevalent are peptide therapeutic products? A critical review.
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DOI：
10.1016/j.ijpharm.2020.119491
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发表时间：
2020-09-25
影响因子：
5.8
通讯作者：
Williams, Robert O., III
中科院分区：
文献类型：
--
作者：
Zhang, Yajie;Zhang, Hairui;Ghosh, Debadyuti;Williams, Robert O., III
肽治疗产品有多流行？用于输送肽的配方有多创新？本综述对美国食品和药物管理局 (FDA)、欧洲药品管理局 (EMA) 和日本药品和医疗器械管理局 (PMDA) 批准的治疗性肽产品和配方进行了严格分析。本综述还深入分析了肽治疗剂的剂型和给药途径，包括注射剂、口服剂型和其他给药途径。我们详细讨论了赋形剂在肠胃外制剂中的功能，因为大多数肽治疗剂都是肠胃外给药的。我们提供替代给药途径和剂型的案例研究。根据我们的分析，作为注射剂施用的治疗肽仍然是最常用的剂型，特别是皮下、静脉内或肌内注射的形式。此外，治疗性肽通常通过使用聚合物载体来配制以实现延长释放。口服治疗肽产品的数量有限、吸收差以及随后的生物利用度低，表明需要新技术来拓宽制剂设计空间。治疗性肽产品还可以通过其他施用途径递送，包括鼻内、植入和舌下途径。因此，深入了解治疗性肽的配制和给药方式对于改善肽递送、提高患者依从性和减轻这些关键治疗药物的医疗负担至关重要。
How prevalent are peptide therapeutic products? How innovative are the formulations used to deliver peptides? This review provides a critical analysis of therapeutic peptide products and the formulations approved by the United States Food and Drug administration (FDA), the European Medicines Agency (EMA), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). This review also provides an in-depth analysis of dosage forms and administration routes for delivering peptide therapeutics, including injectables, oral dosage forms, and other routes of administration. We discuss the function of excipients in parenteral formulations in detail, since most peptide therapeutics are parenterally administered. We provide case studies of alternate delivery routes and dosage forms. Based on our analysis, therapeutic peptides administered as injectables remain the most commonly used dosage forms, particularly in the form of subcutaneous, intravenous, or intramuscular injections. In addition, therapeutic peptides are formulated to achieve prolonged release, often through the use of polymer carriers. The limited number of oral therapeutic peptide products and their poor absorption and subsequent low bioavailability indicate a need for new technologies to broaden the formulation design space. Therapeutic peptide products may also be delivered through other administration routes, including intranasal, implant, and sublingual routes. Therefore, an in-depth understanding of how therapeutic peptides are now formulated and administered is essential to improve peptide delivery, improve patient compliance, and reduce the healthcare burden for these crucial therapeutic agents.
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影响因子：
3.8
作者：
Al-Hussein, Anas;Gieseler, Henning
通讯作者：
Gieseler, Henning
影响因子：
14.2
作者：
Bernstein, IL
通讯作者：
Bernstein, IL
影响因子：
3
作者：
Banks WA
通讯作者：
Banks WA
DOI：
10.1007/bf02996761
发表时间：
1998-01-01
期刊：
Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India
影响因子：
--
作者：
Birdi, S M;Singh, S;Singh, A
通讯作者：
Singh, A
影响因子：
15
作者：
BALARAM, H;PRASAD, BVV;BALARAM, P
通讯作者：
BALARAM, P