簡易懸濁法におけるプラバスタチン製剤の先発医薬品と後発医薬品の比較検討

概要

論文の詳細を見る
For tube administration of tablets and capsules, the simple suspension method has been developed in which tablets or capsules are allowed to directly disintegrate and become suspended in hot water (55℃). In the present study, we focused on generic drugs, which have been increasingly used in recent years, and investigated the recovery of pravastatin after suspending generic and original brand-name drugs using the simple suspension method. The results showed that the original drug disintegrated and became suspended in hot water within 10 minutes, with no problems regarding tube passage and recovery of almost 100% before and after tube passage. In contrast, among generic drugs, two tablets failed to disintegrate and become suspended within 10 minutes. When these tablets were crushed in advance, no problems were observed regarding tube passage, and recovery was almost 100% before and after tube passage. These results confirmed the validity of simple suspension method for pravastatin tablets with regard to both drug stability and the amount actually administered to patients. However, because certain generic drugs differed from the original drug in terms of disintegration and suspension, caution must be exercised when replacing original drugs with generic drugs during application of the simple suspension method.
日本医療薬学会の論文
2008-07-10