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首页> 美国卫生研究院文献>Molecules >Design and Characterizations of Inhalable Poly(lactic-co-glycolic acid) Microspheres Prepared by the Fine Droplet Drying Process for a Sustained Effect of Salmon Calcitonin
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Design and Characterizations of Inhalable Poly(lactic-co-glycolic acid) Microspheres Prepared by the Fine Droplet Drying Process for a Sustained Effect of Salmon Calcitonin

机译：鲑鱼降钙素的细滴干燥工艺制备的可吸入的聚乳酸-乙醇酸共聚物微球的设计与表征

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The present study aimed to develop inhalable poly (lactic- -glycolic acid) (PLGA)-based microparticles of salmon calcitonin (sCT) for sustained pharmacological action by the fine droplet drying (FDD) process, a novel powderization technique employing printing technologies. PLGA was selected as a biodegradable carrier polymer for sustained-release particles of sCT (sCT/SR), and physicochemical characterizations of sCT/SR were conducted. To estimate the in vivo efficacy of the sCT/SR respirable powder (sCT/SR-RP), plasma calcium levels were measured after intratracheal administration in rats. The particle size of sCT/SR was 3.6 µm, and the SPAN factor, one of the parameters to present the uniformity of particle size distribution, was calculated to be 0.65. In the evaluation of the conformational structure of sCT, no significant changes were observed in sCT/SR even after the FDD process. The drug release from sCT/SR showed a biphasic pattern with an initial burst and slow diffusion in simulated lung fluid. sCT/SR-RP showed fine inhalation performance, as evidenced by a fine particle fraction value of 28% in the cascade impactor analysis. After the insufflation of sCT samples (40 µg-sCT/kg) in rats, sCT/SR-RP could enhance and prolong the hypocalcemic action of sCT possibly due to the sustained release and pulmonary absorption of sCT. From these observations, the strategic application of the FDD process could be efficacious to provide PLGA-based inhalable formulations of sCT, as well as other therapeutic peptides, to enhance their biopharmaceutical potentials.
机译：本研究旨在开发鲑鱼降钙素（sCT）的可吸入的基于聚（乳酸-乙醇酸）（PLGA）的微粒，以通过细滴干燥（FDD）工艺（一种采用印刷技术的新型粉末化技术）来维持药理作用。选择PLGA作为sCT缓释颗粒（sCT / SR）的可生物降解载体聚合物，并对sCT / SR进行了理化表征。为了评估sCT / SR可吸入粉剂（sCT / SR-RP）的体内功效，在大鼠气管内给药后测量了血浆钙水平。 sCT / SR的粒径为3.6μm，SPAN系数（表示粒径分布均匀性的参数之一）为0.65。在评估sCT的构象结构时，即使在FDD过程之后，sCT / SR也没有观察到明显的变化。从sCT / SR释放的药物显示出双相模式，在模拟肺液中具有初始爆发和缓慢扩散。 sCT / SR-RP表现出良好的吸入性能，级联撞击器分析中的28％细颗粒分数证明了这一点。在大鼠中注入sCT样品（40 µg-sCT / kg）后，sCT / SR-RP可能增强和延长sCT的降钙作用，可能是由于sCT的持续释放和肺吸收所致。从这些观察结果来看，FDD工艺的战略应用可能会有效地提供基于PLGA的sCT吸入制剂以及其他治疗性肽，以增强其生物制药潜力。

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