why choose us

300×250 Ad Slot

Research Article: Study on the Preparation Method of Quality-Assured In-Hospital Drug Formulation for Children—A Multi-Institutional Collaborative Study

Date Published: 2023-07-10

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.

Introduction:
In pediatric medical practice in Japan, tablets are often crushed, or capsules decapsulated in the pharmaceutical department of medical facilities when oral formulations are not flexible for dose adjustment or when tablets cannot be administered as supplied without modification [1,2,3]. With the increasing demand for drug information, information on the stability of tablets after crushing is sometimes provided by the pharmaceutical companies that manufacture and sell the tablets. On the other hand, in actual…

Read more

300×250 Ad Slot