Development of granulation method using dispensing equipment for pediatric formulations

2021 Fiscal Year Final Research Report

• Project/Area Number: 19K07196
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Review Section: Basic Section 47060:Clinical pharmacy-related
• Research Institution: University of Shizuoka
• Principal Investigator: Miyazaki Yasunori 静岡県立大学, 薬学部, 准教授 (40551742)
• Project Period (FY): 2019-04-01 – 2022-03-31
• Keywords: 湿式造粒法 / 自転公転式調剤ミキサー / 工程パラメータ / 小児用製剤 / 顆粒剤 / ゲル化製剤

Outline of Final Research Achievements

A novel wet granulation method using a planetary centrifugal dispensing mixer was established by clarifying the manufacturing scale and major process factors and their effects. In addition, we have prepared granule formulations of drugs have been reformulated from tablets or capsules to powder form in pediatric pharmacotherapy, and have conducted formulation tests of granules, and then have succeeded in preparing clinically usable granule formulations. Furthermore, a new pediatric formulation of pregel granules that gelatinizes when watered immediately before administration was developed using this method.

Free Research Field

臨床製剤学

Academic Significance and Societal Importance of the Research Achievements

小児用製剤がない場合、成人用製剤を粉砕し用いているが、粉砕物は苦味や臭いを呈し服用困難な場合が多い。本技術により、薬剤師が薬局内で調剤機器を用いて、錠剤粉砕物や脱カプセル物を簡便に造粒することが可能となる。新たな小児用製剤として顆粒剤を調製することで、服用性を改善し、小児患者の薬物治療に用いることができる。市場での小児用製剤の欠如を補完し、小児薬物療法の治療効果の向上に資するものである。