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Quantitative Evaluation of the Disintegration of Orally Rapid Disintegrating Tablets by X-Ray Computed Tomography

机译:X射线计算机断层摄影术对口腔快速崩解片崩解的定量评估

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To measure the rapid disintegration of Oral Disintegrating Tablets (ODT), a new test (XCT) was developed using X-ray computing tomography (X-ray CT). Placebo ODT, rapid disintegration candy (RDC) and Gaster?-D-Tablets (GAS) were used as model samples. All these ODTs were used to measure oral disintegration time (DT) in distilled water at 37±2°C by XCT. DTs were affected by the width of mesh screens, and degree to which the tablet holder vibrated from air bubbles. An in-vivo tablet disintegration test was performed for RDC using 11 volunteers. DT by the in-vivo method was significantly longer than that using the conventional tester. The experimental conditions for XCT such as the width of the mesh screen and degree of vibration were adjusted to be consistent with human DT values. Since DTs by the XCT method were almost the same as the human data, this method was able to quantitatively evaluate the rapid disintegration of ODT under the same conditions as inside the oral cavity. The DTs of four commercially available ODTs were comparatively evaluated by the XCT method, conventional tablet disintegration test and in-vivo method.
机译:为了测量口腔崩解片(ODT)的快速崩解,使用X射线计算机断层扫描(X射线CT)开发了一种新的测试(XCT)。安慰剂ODT,快速崩解糖(RDC)和Gaster?-D-Tablets(GAS)用作模型样品。所有这些ODT均通过XCT用于测量在37±2°C的蒸馏水中的口腔崩解时间(DT)。 DT受网筛的宽度以及片剂支架因气泡振动的程度的影响。使用11名志愿者对RDC进行了体内片剂崩解测试。体内方法的DT明显长于传统测试仪的DT。调整XCT的实验条件,例如筛网的宽度和振动程度,使其与人的DT值一致。由于XCT方法的DT与人类数据几乎相同,因此该方法能够在与口腔内相同的条件下定量评估ODT的快速崩解。通过XCT方法,常规片剂崩解试验和体内方法对四种市售ODT的DT进行了比较评估。

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