Novel platform for sustained release of biopharmaceucal by using porous PLGA particle

2022 Fiscal Year Final Research Report

• Project/Area Number: 20K07203
• 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: Nagoya City University
• Principal Investigator: Ozeki Tetsuya 名古屋市立大学, 医薬学総合研究院(薬学), 教授 (60277259)
• Co-Investigator(Kenkyū-buntansha): 田上 辰秋 名古屋市立大学, 医薬学総合研究院(薬学), 准教授 (10609887)
• Project Period (FY): 2020-04-01 – 2023-03-31
• Keywords: 徐放製剤 / ポリ乳酸-グリコール酸共重合体（PLGA）

Outline of Final Research Achievements

Although biopharmaceuticals are expected to provide highly effective treatment with fewer side effects, they are susceptible to degradation and often need to be administered frequently by injection. Therefore, there is a need for a formulation technology that protects biopharmaceuticals from degradation and enables sustained release. In this study, we succeeded in encapsulating proteins into poly(lactic acid)-glycolic acid copolymer (PLGA) using a unique strategy; adsorbing the biopharmaceutical within porous and cationic PLGA microparticles and then sealing the pores. It was shown that the encapsulated proteins were released slowly over a long period of time while retaining their function. This study provides a new formulation technology for biopharmaceuticals.

Free Research Field

製剤学

Academic Significance and Societal Importance of the Research Achievements

医薬品の徐放製剤は古くから開発されているものの、バイオ医薬品に対する徐放製剤は報告が少ない。最新のバイオ医薬品が研究される一方で、最近では、バイオ後続品（バイオシミラー）の承認も活発になっている。後発医薬品の開発においては、先発品にはない価値を創造することが期待されている。本研究で得られた成果は、バイオ医薬品の徐放化を通じてバイオシミラーの価値を高める製剤化技術を提供できると考えている。