配药过程中的药物损失和包装上的粘附:作为模型剂型的苯妥英产品

S. Miyamoto, Y. Kohda, Masaru Suzuki, E. Sagara
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引用次数: 3

摘要

众所周知,苯妥英的生物利用度取决于剂型,因为在医生开的处方中,经常订购苯妥英碎片而不是粉状。在本研究中研究的是由于配药过程和依从包装导致的药物重量减轻。以苯妥英磨片、细颗粒和粉剂三种剂型为模型剂型。模拟配药的方法是将片剂与辅料一起磨碎,用研钵和杵混合,用两种包装机进行分装配药。总重量损失的程度既不取决于包装机器的类型,也不取决于苯妥英的剂型,除了磨碎的片剂。对于磨碎的片剂,在配药过程中观察到大量的重量减轻,这种现象是由包装过程中的飞溅引起的。观察到细颗粒和粉末相对于配药过程有一个小的重量损失,而一个大的重量损失涉及到包装的粘附性。无论何种苯妥英剂型,分配和包装依从性的总损失均为6%。我们得出结论,粉末状的细颗粒苯妥英是最合适的剂型,因为它的生物利用度与片剂形式相当,而且在配药过程中重量只有轻微的损失。
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Drug-Loss in Dispensing Process and Adhering to the Package : Phenytoin Products as Model Dosage Forms
The bioavailability of phenytoin is well known to be dependent on the dosage forms as is the fact that ground tablets of phenytoin are often ordered instead of the powdered form in doctorwritten prescriptions. Studied in the present study was weight loss of the drug resulting from the dispensing process and adherence to the package.Used as model forms were three dosage forms of phenytoin: ground tablets, fine granules and powder. Simulative dispensing was performed using the conventional method in which tablets were ground with excipients, mixed with a mortar and pestle, and divided and packaged employing two kinds of packaging machines for dispensing.The extent of total weight in loss was dependent neither on the types of packaging machines, nor on the dosage forms of phenytoin except for ground tablets. For ground tablets, a large weight loss was observed in the dispensing process, with this phenomenon being caused by splashing in the packaging process. Observed with fine granules and powder was a small weight loss relative to the dispensing process and a large one involving adherence to the package. The total loss in dispensing and package adherence was found to be 6% regardless of the phenytoin dosage form.We conclude that fine granules in the powdered form of phenytoin are the most suitable dosage form because of the compositis equivalent bioavailability to the tablet form and its only slight loss in weight during the dispensing process.
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