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渗透控释口服给药系统(OROS)的临床应用范围,一种先进的口服给药形式。

Clinical spectrum of the osmotic-controlled release oral delivery system (OROS), an advanced oral delivery form.

作者信息

Conley Robert, Gupta Suneel K, Sathyan Gayatri

机构信息

Maryland Psychiatric Research Center, Baltimore, MD 21228, USA.

出版信息

Curr Med Res Opin. 2006 Oct;22(10):1879-92. doi: 10.1185/030079906x132613.

DOI:10.1185/030079906x132613
PMID:17022845
Abstract

BACKGROUND

The osmotic-controlled release oral delivery system, OROS, is an advanced drug delivery technology that uses osmotic pressure as the driving force to deliver pharmacotherapy, usually once-daily, in several therapeutic areas.

OBJECTIVE

The purpose of this review is to discuss the evolution of OROS technology and examine the many therapeutic areas where OROS products are being used.

METHODS

A search of Medline and EMBASE were performed using the keywords 'OROS' and 'osmotic delivery' for the period January 1990 to June 2005. Data were also obtained from the manufacturers' websites and associated publications.

RESULTS

OROS technology has evolved over the last 30 years, resulting in four systems: the elementary osmotic pump; the two-layer osmotic push-pull tablet; the advanced longitudinally compressed tablet multilayer formulation; and, the L-OROS system. OROS technology is employed for drug delivery in many therapeutic areas including: cardiovascular medicine, endocrinology, urology, and central nervous system (CNS) therapeutics. Two calcium channel blockers utilizing OROS technology for the treatment of hypertension are nifedipine and verapamil. Glipizide extended-release is used for the treatment of type 2 diabetes. Doxazosin is used for the treatment of benign prostatic hyperplasia, and oxybutynin for overactive bladder. Most recent developments are with drugs that affect the CNS, including the use of methylphenidate for treatment of attention deficit hyperactivity disorder, paliperidone extended-release and OROS hydromorphone, which are under clinical development for schizophrenia and chronic pain, respectively.

CONCLUSIONS

Drug delivery using the various OROS products can result in an improved safety profile, stable drug concentrations, uniform drug effects, and reduced dosing frequency. OROS technology has also enabled the use of an effective starting dose, without the need for dose titration, which allows the achievement of symptom control much earlier than that observed with immediate-release preparations. Such attributes can enhance patient compliance and convenience, thereby ensuring efficacy and improving patient outcomes.

摘要

背景

渗透控释口服给药系统(OROS)是一种先进的药物递送技术,它利用渗透压作为驱动力来递送药物治疗,通常每日一次,应用于多个治疗领域。

目的

本综述的目的是讨论OROS技术的发展历程,并考察使用OROS产品的众多治疗领域。

方法

使用关键词“OROS”和“渗透递送”对1990年1月至2005年6月期间的Medline和EMBASE进行检索。数据还从制造商网站及相关出版物中获取。

结果

OROS技术在过去30年中不断发展,产生了四种系统:基本渗透泵;双层渗透推拉片;先进的纵向压缩片多层制剂;以及L-OROS系统。OROS技术用于许多治疗领域的药物递送,包括:心血管医学、内分泌学、泌尿学和中枢神经系统(CNS)治疗。两种利用OROS技术治疗高血压的钙通道阻滞剂是硝苯地平和维拉帕米。格列吡嗪缓释片用于治疗2型糖尿病。多沙唑嗪用于治疗良性前列腺增生,奥昔布宁用于治疗膀胱过度活动症。最新进展在于影响中枢神经系统的药物,包括使用哌甲酯治疗注意力缺陷多动障碍,帕利哌酮缓释片和OROS氢吗啡酮分别处于精神分裂症和慢性疼痛的临床开发阶段。

结论

使用各种OROS产品进行药物递送可改善安全性、稳定药物浓度、使药物效果均匀并减少给药频率。OROS技术还使得能够使用有效的起始剂量,而无需剂量滴定,这比速释制剂更早实现症状控制。这些特性可提高患者的依从性和便利性,从而确保疗效并改善患者预后。

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