1. Study on the Preparation Method of Quality-Assured In-Hospital Drug Formulation for Children—A Multi-Institutional Collaborative Study.
- Author
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Saito, Jumpei, Suzuki, Eiji, Nakamura, Yosuke, Otsuji, Takashi, Yamamoto, Hiroshi, Yamamoto, Hideki, Kai, Yuiko, Totsu, Maiko, Hashimoto, Sayuki, Nakamura, Hidefumi, Akabane, Miki, and Yamatani, Akimasa
- Subjects
RESEARCH ,DRUG packaging ,QUALITY assurance ,BACLOFEN ,DRUG stability ,RESEARCH funding ,PHARMACEUTICAL chemistry ,CLONIDINE ,DRUG storage ,DOSAGE forms of drugs ,HYDROCORTISONE ,POWDERS - Abstract
The quality-assured preparation of crushed and diluted preparations for children is a challenge. In this study, a multicenter study was conducted to validate the preparation method for the quality assurance of baclofen powder, clonidine powder, and hydrocortisone powder prepared from tablets according to a previously established method. In-hospital preparations were prepared at five medical facilities under different crushing and mixing conditions. After storage in closed bottles, in-use bottles, and laminated paper for 120 days, ingredients stability, drug elution, and content uniformity after packaging were evaluated. All three ingredients were maintained at between 90% and 110% of their initial content for 120 days under packaging conditions of 25 ± 2 °C and 60 ± 5% relative humidity, with no change in dissolution in all formulations made at all five facilities. The content uniformity was also acceptable. The established method may contribute to quality-assured pediatric dosage form modification. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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