通过热熔挤出法配制无定形固体分散体的创新载体，无需进一步的下游工艺：吲哚美辛案例研究。

IF 2.6 4区医学 Q2 PHARMACOLOGY & PHARMACY Pharmaceutical Development and Technology Pub Date : 2024-02-01 Epub Date: 2024-01-25 DOI:10.1080/10837450.2024.2306802

S P Lacerda, S Del Confetto, L Haurie, M Bernard, S Faget, M I Ré

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引用次数: 0

摘要

这项工作的目的是研究是否有可能使用 SepitrapTM 作为载体，通过 HME（热熔挤出）工艺配制无定形固体分散体，以提高水溶性差的药物的溶解度。SepitrapTM 是一种微胶囊粉末增溶剂，旨在简化口服固体药物的生产，但尚未进行过相关测试。以吲哚美辛为模型药物，对 SepitrapTM 的性能进行了评估。研究使用双螺杆挤出机、两种 SepitrapTM 成分和不同的吲哚美辛用量进行，结果表明，SepitrapTM 可以作为一种新的载体，用于非晶固体分散体的 HME 加工，减少了研磨等必要的下游步骤。

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An innovative carrier for the formulation of amorphous solid dispersion by hot-melt extrusion with no further downstream processes: a case study with indomethacin.

The aim of this work was to study the possibility to use Sepitrap^TM as a carrier for the formulation of amorphous solid dispersions by HME (hot melt extrusion) processing aiming solubility enhancement of poorly water-soluble drugs. Sepitrap^TM is a microencapsulated powder solubilizer designed to simplify the manufacture of drugs in oral solid forms, not yet tested for this purpose. The performance of Sepitrap^TM was evaluated in HME processing for amorphous solid dispersions of poorly-water soluble drugs with indomethacin as a model drug. The study was conducted using a twin-screw extruder, two compositions of Sepitrap^TM and different loads of indomethacin, demonstrating that Sepitrap^TM could represent a new range of carriers for amorphous solid dispersions for HME processing, reducing necessary downstream steps such as grinding.

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来源期刊

Pharmaceutical Development and Technology 医学-药学

CiteScore

5.90

自引率

2.90%

发文量

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.