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2023 Fiscal Year Final Research Report

A redesigned pulmonary formulation platform: Preparation of carrier particles with advanced alveolar transportability

Research Project

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Project/Area Number 21K06504
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Review Section Basic Section 47020:Pharmaceutical analytical chemistry and physicochemistry-related
Research InstitutionOsaka Medical and Pharmaceutical University

Principal Investigator

Tozuka Yuichi  大阪医科薬科大学, 薬学部, 教授 (50312963)

Co-Investigator(Kenkyū-buntansha) 門田 和紀  大阪医科薬科大学, 薬学部, 准教授 (50709516)
Project Period (FY) 2021-04-01 – 2024-03-31
Keywords吸入粉末剤 / コンポジット粒子 / 噴霧乾燥法 / 実験計画法 / フィトグリコーゲン / マトリックス / デキストラン / 噴霧凍結乾燥法
Outline of Final Research Achievements

Phytoglycogen (PyG) was used as a multi-functional additive that enhances pulmonary delivery of drugs. Dry powder inhaler (DPI) formulations of an antitubercular drug, rifampicin, were fabricated by spray drying with PyG. Extra-fine particle fraction (eFPF, the fraction of particles with aerodynamic size <2 μm) is an essential metric to evaluate the deep lung delivery of DPIs. The product of spray-drying has the potential to be applied in DPI formulations regarding its controllable size. By using a design space compiled from response surfaces, the most critical factor controlling inhalation properties was gas flow rate. The fine particle fraction of the porous particle batch reached nearly 60%, whereas in the formulation containing wrinkled carrier particles, eFPF was 25.0%. The inclusion of PyG dramatically improved the inhalation performance of porous and wrinkled powder formulations.

Free Research Field

製剤学、物理薬剤学

Academic Significance and Societal Importance of the Research Achievements

経肺投与製剤は、薬効の発現が早く、気管支喘息などの肺局所治療だけでなく、全身性疾患治療にも応用可能である。経肺投与製剤のうち、吸入粉末剤は携帯性に優れ、吸入しやすい利点を有するが、現行市販品の製剤処方による吸入粉末剤は気管支までの到達が限度であり、薬物を肺深部炎症部位に直接到達可能なキャリアの開発には至っていない。
薬物と添加剤との間でコンポジット粒子を作製する場合には、粒子径や形状などの粒子物性を制御した粒子設計が課題であり、本研究成果で得られた、医薬品―添加剤による高度肺到達性の可能性を持ったコンポジット粒子作成法は、吸入粉末剤設計の新たな可能性を示している。

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Published: 2025-01-30  

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