||Study on the Characteristics of Zolpidem Orally Disintegrating Tablets from Different Formulations
井上, 裕 ,
下条, 明日香 ,
Tunvichien, Sujimon ,
新山, 大地金本, 郁男
Journal of Drug Research and Development
6 , 2017-02 , Sci Forschen
Objective: The aim of this study was to examine zolpidem (ZLP) orally disintegrating tablets (ODTs) from different formulations in order to characterize their physicochemical properties and thus, provide the necessary prescribing and dispensing information on those preparations.Methods: Five 5-mg-ZLP ODTs from five different formulations were used in this study. These tablets were subjected to weight and content uniformity tests as indicators of quality. In addition, they were subjected to dissolution, wetting time, hardness, and disintegration tests.Results: The content uniformity test ensured that preparations contained a uniform quantity of the active ingredient. The weight of each preparation was the same as that listed on the package insert. In the dissolution test, all the preparations had dissolved by at least 85% after 15 min. The hardness test showed that, on average, all the preparations had a hardness of at least 30 N. Results of the wetting time and disintegration tests indicated that the five preparations have different mechanisms of disintegration. Conclusion: Our results revealed differences in the physicochemical properties between the five formulations. We concluded from this study that formulation differences could affect the disintegration, dissolution, and absorption of ODTs. In order to provide better medical care for each individual patient, it is necessary for the pharmacist to pursue information regarding the pharmaceutical properties of medications.
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