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首页> 美国卫生研究院文献>Pharmaceutics >How Do Orodispersible Tablets Behave in an In Vitro Oral Cavity Model: A Pilot Study
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How Do Orodispersible Tablets Behave in an In Vitro Oral Cavity Model: A Pilot Study

机译：如何在体外口腔模型中表现如何在体外口腔模型：试点研究

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Orodispersible tablets (ODTs) offer rapid disintegration of the dosage form when placed on the tongue, which leads to fast release of the active pharmaceutical ingredient. Despite increased use in diverse patient populations, there have been numerous challenges associated with ODTs. One such concern is the lack of standardised assessment of disintegration behaviour. In the European Pharmacopoeia, ‘orodispersibles’ are defined as such if disintegration time is faster than 3 min. Common in vitro measurement methods only provide single time point data and have limited physiological accuracy. To determine more bio-predictive disintegration kinetics, a bench-top in vitro oral cavity model (OCM) was modified and piloted to assess disintegration of three ODTs of differing hardness. All ODTs disintegrated similarly within the OCM—surface breakdown/swelling, initial ‘wash away’ and final ‘wash away’. The distinct advantage presented within this pilot study using the OCM is the opportunity to ascertain disintegration behaviour profiles of ODTs by evaluating changes in the observable area during simulated oral processing. The model could be implemented as a decision-support tool during the early stages of the drug design process to improve acceptability and further understand ODT disintegration behaviour.
机译：在舌头上置于舌片时，Orodispersible片剂（ODTS）提供了用量形式的快速崩解，这导致活性药物成分的快速释放。尽管在不同的患者群体中增加了不同，但与ODTS有多挑战。一个这一关注的是缺乏对崩解行为的标准化评估。在欧洲药典中，“orodispersibles”定义为诸如崩解时间的速度超过3分钟。常见的体外测量方法仅提供单个时间点数据并具有有限的生理学准确性。为了确定更多生物预测性崩解动力学，改性和试点改变了稳压体外腔体模型（OCM）以评估不同硬度的三种ODTS的崩解。所有臭氧在OCM表面击穿/肿胀中同样崩解，初始“冲走”和最终“冲走”。使用OCM在该试点研究中呈现的明显优势是通过在模拟口服处理期间评估可观察区域的变化来确定ODTS的崩解行为谱的机会。该模型可以在药物设计过程的早期阶段实现作为决策支持工具，以提高可接受性并进一步了解ODT崩解行为。

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