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一项评估新型口服片剂包衣增强吞咽及掩味特性的随机交叉研究。

A randomized cross-over study to evaluate the swallow-enhancing and taste-masking properties of a novel coating for oral tablets.

作者信息

Uloza Virgilijus, Uloziene Ingrida, Gradauskiene Egle

机构信息

Department Otolaryngology, Kaunas University of Medicine, Eiveniu 2, 50009 Kaunas, Lithuania.

出版信息

Pharm World Sci. 2010 Aug;32(4):420-3. doi: 10.1007/s11096-010-9399-4. Epub 2010 Jun 4.

Abstract

OBJECTIVE

To explore the swallowing-enhancing and taste-masking effects of MedCoat, a new disposable device used to apply a coating to tablets just before oral administration.

SETTING

Kaunas Medical University Hospital in Lithuania.

METHOD

The study was performed as a randomized cross-over study. In total 41 subjects (20 male and 21 female) were enrolled in the study. Subjects were healthy volunteers who at least sometimes experience difficulties swallowing tablets. Subjects were asked to swallow placebo tablets uncoated and coated with MedCoat in a randomized order, and indicate their preferences. Subjects were also asked to evaluate the taste-masking properties of MedCoat.

RESULTS

Of the 41 subjects, 40 (97.6%) found it less difficult to swallow non-flavoured placebo tablets coated with MedCoat compared to identical uncoated tablets. Forty subjects (97.6%) found it less difficult to swallow divided non-flavoured placebo tablets coated with MedCoat compared to identical uncoated divided tablets. All 41 subjects (100.0%) found it less difficult to swallow bitter flavoured placebo tablets coated with MedCoat compared to identical uncoated tablets. All 41 (100.0%) of the subjects stated that MedCoat completely masked the bitter taste of a bitter flavoured tablet.

CONCLUSION

The study showed that MedCoat made tablets easier to swallow for people with difficulties swallowing tablets and that it masked the taste of bitter tasting tablets. MedCoat could therefore be a valuable tool to aid the oral taking of tablets for patients who have difficulties swallowing tablets.

摘要

目的

探讨MedCoat(一种新型一次性装置,用于在口服前给片剂包衣)的吞咽促进和掩味效果。

地点

立陶宛考纳斯医科大学医院。

方法

该研究以随机交叉研究的方式进行。共有41名受试者(20名男性和21名女性)参与了研究。受试者为健康志愿者,他们至少有时会遇到吞咽片剂困难的情况。要求受试者以随机顺序吞咽未包衣和用MedCoat包衣的安慰剂片剂,并表明他们的偏好。还要求受试者评估MedCoat的掩味特性。

结果

在41名受试者中,40名(97.6%)发现与相同的未包衣片剂相比,吞咽用MedCoat包衣的无味安慰剂片剂更轻松。40名受试者(97.6%)发现与相同的未分割的未包衣片剂相比,吞咽用MedCoat包衣的分割无味安慰剂片剂更轻松。所有41名受试者(100.0%)发现与相同的未包衣片剂相比,吞咽用MedCoat包衣的苦味安慰剂片剂更轻松。所有41名(100.0%)受试者表示,MedCoat完全掩盖了苦味片剂的苦味。

结论

该研究表明,MedCoat使吞咽片剂困难的人更容易吞咽片剂,并且它掩盖了苦味片剂的味道。因此,对于吞咽片剂有困难的患者,MedCoat可能是辅助口服片剂的一种有价值的工具。

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