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    2020年国外新批准上市的新制剂

    摘要

    2020年国外批准上市的药物新制剂主要有三类。口服制剂:服用方便的口服液、膜剂和口崩片,自微乳化释药系统技术制备的液体制剂可提高生物利用度;复方片、控释药物制剂减少给药次数、提高疗效和改善患者服药的顺应性;阿扎胞苷和奥曲肽原只有注射剂,制成口服制剂改变给药途径方便治疗。注射剂:药物纳米微球和缓释注射剂可提高疗效,含透明质酸酶的复方药物皮下注射剂可缩短给药时间,3种药物-抗体偶联物注射剂可提高药物靶向性,达到精准治疗目标。外用制剂:洗剂、乳膏、软膏和凝胶用药方便,经皮控释贴片可控制药物释放;通过局部给药达到全身性治疗的鼻腔喷雾剂;据预测,复方醋酸茚达特罗、格隆溴铵、糠酸莫米松吸入剂上市后年销售峰值逾10亿美元。

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    Abstract

    New pharmaceutical preparations approved for marketing abroad in 2020 mainly include oral preparations:oral liquids,films and orally disintegrating tablets convenient for taking,liquid preparations prepared by self-microemulsifying drug delivery system technology,which can improve bioavailability;compound tablets,controlled-release drugs,which will reduce the number of administrations,improve efficacy and the compliance of patients with medication;azacitidine and octreotide used to be only injections,and they are made into oral preparations to change the route of administration to facilitate treatment. Injections:drug nanospheres and sustained-release injections can improve efficacy;hyaluronidase-containing compound drug subcutaneous injections can shorten the administration time;three drug-antibody conjugate injections can improve drug targeting and achieve precise treatment goals. External preparations:lotions,creams,ointments and gels are easy to use;transdermal controlled-release patches can control drug release;nasal sprays achieve systemic treatment through local administration;it is predicted that the peak annual sales of compound indacaterol acetate/glycopyrronium bromide/mometasone furoate inhalation after its launch will exceed US$1 billion.

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    作者简介
    黄胜炎:黄胜炎,上海医药工业研究院研究员。
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