Microbicide vaginal rings: Technological challenges and clinical development

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• 作者：R. Karl Malcolm ; ^{k.malcolm@qub.ac.uk" class="auth_mail" title="E-mail the corresponding author} ; Peter J. Boyd ; Clare F. McCoy ; Diarmaid J. Murphy
• 关键词：ACV ; acyclovir ; AIDS ; acquired immunodeficiency syndrome ; API ; active pharmaceutical ingredient ; ARV ; antiretroviral ; AZT ; zidovudine ; Boc-LBA ; Boc-lysinated betulonic acid ; CG ; carrageenan ; DMPA ; depot medroxyprogesterone acetate ; DPV ; dapivirine ; DRV ; darunavir ; E2 ; estradiol ; EE ; ethinylestradiol ; ETN ; etonogestrel ; EVA ; ethylene vinyl acetate copolymer ; FDA ; U.S. Food and Drug Administration ; GMP ; good manufacturing practice ; GRFT ; griffithsin ; HAART ; highly active antiretroviral therapy ; HI
• 刊名：Advanced Drug Delivery Reviews
• 出版年：2016
• 出版时间：1 August 2016
• 年：2016
• 卷：103
• 期：Complete
• 页码：33-56
• 全文大小：2374 K

文摘

Vaginal rings (VRs) are flexible, torus-shaped, polymeric devices designed to sustain delivery of pharmaceutical drugs to the vagina for clinical benefit. Following first report in a 1970 patent application, several steroid-releasing VR products have since been marketed for use in hormone replacement therapy and contraception. Since 2002, there has been growing interest in the use of VR technology for delivery of drugs that can reduce the risk of sexual acquisition of human immunodeficiency virus type 1 (HIV-1), the causative agent of acquired immunodeficiency syndrome (AIDS). Although no vaginally-administered product has yet been approved for HIV reduction/prevention, extensive research efforts are continuing and a number of VR devices offering sustained release of so-called ‘HIV microbicide’ compounds are currently being evaluated in late-stage clinical studies. This review article provides an overview of the published scientific literature within this important field of research, focusing primarily on articles published within peer-reviewed journal publications. Many important aspects of microbicide-releasing VR technology are discussed, with a particular emphasis on the technological, manufacturing and clinical challenges that have emerged in recent years.