2022 Fiscal Year Final Research Report
Development of a continuous manufacturing system for orodispersible films: Towards personalized formulations
Project/Area Number |
20K07167
|
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 | Meiji Pharmaceutical University |
Principal Investigator |
Inoue Motoki 明治薬科大学, 薬学部, 講師 (90722950)
|
Project Period (FY) |
2020-04-01 – 2023-03-31
|
Keywords | 個別製剤化 / 口腔内崩壊製剤 / インラインモニタリング / オンデマンド製造 |
Outline of Final Research Achievements |
Orodispersible films are promising oral dosage forms for special populations. To enable continuous manufacturing of orodispersible films, monitoring of the active pharmaceutical ingredient contained in the final product is essential. This study has proved the feasibility of Raman monitoring of active pharmaceutical ingredients within continuously manufactured orodispersible films for individual dosing. To evaluate the quantitative ability of this method, the root means-square error of cross-validation was determined by comparing the actual concentration and predicted content by a calibration curve. In this study, the API content in the film can be monitored even for conveys faster than the actual conveying speed during the drying procedure . The results indicate that Raman spectroscopy can quantify the content of active pharmaceutical ingredients in continuously produced orodispersible films.
|
Free Research Field |
物理薬剤学・製剤学
|
Academic Significance and Societal Importance of the Research Achievements |
今回取り組んだラマン分光により非破壊・非接触で口腔内崩壊フィルム中の薬物のインラインモニタリングできることが明らかとなった。本技術は連続的にフィルム製剤中薬物含量を保証できる極めて有用な技術であり、連続生産製剤のモニタリングだけでなく、個別製剤化の今後の進展に貢献できるものと期待できる。長さを調節するだけで有効薬物量を変更できるフィルム製剤のオンデマンド製造が可能になり、高齢者だけでなく小児等の用量調節が必要な患者に対する新たな院内製剤調製プラットフォームとして役立つことが期待できる。
|