Injectable testosterone PLGA microsphere with different characteristics: effect of preparation method (paddle mixing versus microfluidic device).

IF 2.6 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pharmaceutical Development and Technology Pub Date : 2024-06-01 Epub Date: 2024-05-15 DOI:10.1080/10837450.2024.2348580
Yusuke Oe, Masanori Kobayashi, Takayuki Yoshida, Hiroyuki Kojima, Takayuki Terukina, Hiromu Kondo
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Abstract

The purpose of this study was to compare the characteristics of testosterone polylactic-co-glycolic (PLGA) microspheres prepared by a paddle mixer or microfluidics device. The comparison was conducted by not only in vitro evaluation but also in vivo evaluation which has not been reported up to date. We discovered that, among the steps in microsphere preparation, the solvent removal process strongly impacted drug content, particle size and surface morphology. Spectroscopic measurements suggested that molecular interactions and crystallinity of the drug incorporated in the microspheres differed. For the drug release profile, although both mixer- and microfluidics-prepared samples showed similar sustained release of the incorporated drug for approximately one month in vitro, they exhibited different plasma concentration profiles in vivo. Together, our findings show that the preparation process, especially the solvent removal process, may affect the physicochemical characteristics of testosterone PLGA microspheres, leading to different in vivo performance.

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具有不同特性的可注射睾酮 PLGA 微球:制备方法(桨式混合与微流控装置)的影响
本研究的目的是比较用桨叶混合器或微流控装置制备的睾酮聚乳酸-聚乙二醇(PLGA)微球的特性。比较不仅通过体外评估进行,还通过体内评估进行,而体内评估迄今尚未见报道。我们发现,在微球制备的各个步骤中,溶剂去除过程对药物含量、粒度和表面形态影响很大。光谱测量表明,微球中药物的分子相互作用和结晶度各不相同。在药物释放曲线方面,虽然混合器和微流控制备的样品在体外约一个月的时间内显示出相似的药物持续释放,但在体内却表现出不同的血浆浓度曲线。总之,我们的研究结果表明,制备过程,尤其是去除溶剂的过程,可能会影响睾酮聚乳酸微球的理化特性,从而导致其在体内的表现不同。
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来源期刊
CiteScore
5.90
自引率
2.90%
发文量
82
审稿时长
1 months
期刊介绍: Pharmaceutical Development & Technology publishes research on the design, development, manufacture, and evaluation of conventional and novel drug delivery systems, emphasizing practical solutions and applications to theoretical and research-based problems. The journal aims to publish significant, innovative and original research to advance the frontiers of pharmaceutical development and technology. Through original articles, reviews (where prior discussion with the EIC is encouraged), short reports, book reviews and technical notes, Pharmaceutical Development & Technology covers aspects such as: -Preformulation and pharmaceutical formulation studies -Pharmaceutical materials selection and characterization -Pharmaceutical process development, engineering, scale-up and industrialisation, and process validation -QbD in the form a risk assessment and DoE driven approaches -Design of dosage forms and drug delivery systems -Emerging pharmaceutical formulation and drug delivery technologies with a focus on personalised therapies -Drug delivery systems research and quality improvement -Pharmaceutical regulatory affairs This journal will not consider for publication manuscripts focusing purely on clinical evaluations, botanicals, or animal models.
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