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配制具有改善的可注射性的利福平混悬液,用于鼻胃管肠内喂养给药。

Compounding rifampin suspensions with improved injectability for nasogastric enteral feeding tube administration.

作者信息

de Villiers Melgardt M, Vogel Laura, Bogenschutz Monica C, Fingerhut Bonnie J, D'Silva Joseph B, Moore Anne

机构信息

University of Wisconsin. Madison, WI.

出版信息

Int J Pharm Compd. 2010 May-Jun;14(3):250-6.

Abstract

Often medications that have to be administered to patients via a nasogastric enteral feeding tubes are only available as tablets and capsules with no suitable commercial liquid alternatives. In such situations, pharmacists and nurses have to compound the tablets and capsule contents into liquid suspension formulations for dosing. The risk of occlusion of the enteral tubes during administration is reduced by employing liquid suspensions that are composed of small and uniform particles, not subject to rapid rates of settling, resistant to caking, and easily and uniformly re-suspended upon agitation. Present techniques often employ a manual process, such as a mortar and pestle, to accomplish the particle size reduction and subsequent incorporation into a suitable liquid diluent. A new compounding device has been invented that employs an automated wet-milling process in a single-use disposable plastic container to compound the suspensions. The two processes were compared using Rifampin capsules and various liquid diluents. A prototype version of the new device was employed in the experiments. The physical characteristics of the compounded suspensions were evaluated by determining sedimentation rate, sedimentation volume, and particle size and shape using laser light scattering, optical microscopy, and scanning electron microscopy techniques. The use characteristic of the compounded suspensions was evaluated using a nasogastric tube inject ability test. The results indicated that suspensions prepared using the new device were more resistant to sedimentation and caking and were easier to re-disperse into a uniform mixture by gentle shaking. The results were a consequence of the particles generated by the new device which were found to be smaller and more uniform in shape and size. The suspensions prepared using the new device did not cause blockage of the enteral feeding tubes in comparison to those prepared using a mortar and pastle. In conclusion, the results indicate that the wet-milling process employed by the new compounding device produces liquid suspensions that are more suitable for dosing via nasogastric enteral tubes in comparison to the manual mortar and pestle method that is presently employed.

摘要

通常,必须通过鼻胃肠内喂养管给患者使用的药物仅以片剂和胶囊形式提供,没有合适的商业液体替代品。在这种情况下,药剂师和护士必须将片剂和胶囊内容物配制成液体悬浮制剂用于给药。通过使用由小且均匀的颗粒组成、沉降速度不快、抗结块且搅拌后易于均匀重新悬浮的液体悬浮液,可以降低给药期间肠管堵塞的风险。目前的技术通常采用手动方法,如研钵和研杵,来完成粒度减小并随后加入合适的液体稀释剂中。已发明了一种新的配药装置,该装置在一次性塑料容器中采用自动湿磨工艺来配制悬浮液。使用利福平胶囊和各种液体稀释剂对这两种工艺进行了比较。实验中使用了新装置的原型版本。通过使用激光散射、光学显微镜和扫描电子显微镜技术测定沉降速率、沉降体积以及颗粒大小和形状,对配制的悬浮液的物理特性进行了评估。使用鼻胃管注射能力测试评估了配制的悬浮液的使用特性。结果表明,使用新装置制备的悬浮液更抗沉降和结块,并且通过轻轻摇晃更容易重新分散成均匀混合物。这些结果是由于新装置产生的颗粒形状和大小更小且更均匀。与使用研钵和研杵制备的悬浮液相比,使用新装置制备的悬浮液不会导致肠内喂养管堵塞。总之,结果表明,与目前使用的手动研钵和研杵方法相比,新配药装置采用的湿磨工艺产生的液体悬浮液更适合通过鼻胃肠内管给药。

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