原文:
一、FDA发布的口腔崩解片指导原则内容介绍
1、背景介绍
为提高药物使用的方便性,解决特定适应症和特殊患者人群的用药顺应性,制药企业开发了一类只需放在舌面上就可以咽下的产品。该类产品被设计为当接触唾液后能够迅速崩解和溶解,而无需咀嚼、整片吞咽或用水服用。这种给药方式最初希望能对儿童患者、老年患者、吞咽困难患者以及服药顺应性差的患者(如精神失常患者)带来益处。
1998年,FDA的CDER命名标准委员会根据对早期该类产品的审评情况,首次将该类产品定义为一种新的剂型——口腔崩解片(Orally disintegrating tablet,ODT)。其定义如下:口腔崩解片是一种含药的固体制剂,当放在舌面上时,可以迅速地、通常在几秒钟内崩解。
早期开发的该类产品的特点包括片重低、尺寸小、所含组分溶解性好以及崩解迅速,这些特点支持这类产品的使用目的。
然而,当后续的制药企业使用不同的生产技术和方法生产出另外的产品时,许多后续产品显示出与早期产品较大的变异性。由于这些产品特性的变化可能会对其特定用途的适用性产生影响,因而FDA提出了该针对制药企业的指导原则。
翻译:
Ⅰ Introduction of the guidance
1. Background
In an effort to make drugs easier to administer and leads to better patient compliance , pharmaceutical manufacturers developed a drug dosage form that can be ingested simply by placing on the tongue. The products are designed to disintegrate or dissolve rapidly on contact with saliva, thus obviating the need for chewing, swallowing, or taking with water. This administration mode was initially expected to be beneficial to pediatric and geriatric patients, to those who have difficulties in swallowing, and to patients with bad compliance (e.g. patients with psychiatric disorders).
制药企业开发了一类只需放在舌面上就可以咽下的产品--这里的"产品"我觉得理解为"药物剂型"更为准确,所以这里翻译成a drug dosage form.
无需咀嚼、整片吞咽或用水服用--这里的"无需"我翻译成obviate the need for.请ruojun和poorlittle讲解一下obviate/eliminate和ommit的区别?我在文献中三种用法都见过.
给药方式--有没有比administration mode更好的说法?
After evaluating applications for the initial ODTs, the Nomenclature Standards Committee of CDER (the Center for Drug Evaluation and Research) developed the following definition for an ODT (orally disintegrating tablet) as a new dosage form in 1998: A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.
The initial ODTs exhibited characteristics that supported the intended uses of these products, such as low tablet weight, small size, highly soluble components and rapid disintegration.
呈现……的特征--除了用exhibit之外还有哪些表达方式?
However, as more and more ODTs are developed with different technologies and formulations, many of them exhibited varied characteristics, which are different from the initial products and may affect the suitability for particular uses. That’s why FDA issued this guidance for drug industry.
许多后续产品显示出与早期产品较大的变异性--如poorlittle所说,中文里很多词其实是不必要的,如这里的"后续"二字.as more and more ODTs are developed with different technologies and formulations这句话已经体现出"后续"的意思了,所以后面就用many of them了.
developed with different technologies and formulations--这里应该用with而非by.好像with比by具体吧.