Exploring vacuum foam drying as an alternative to freeze-drying and spray drying for a human lipase

IF 5.3 2区 医学 Q1 PHARMACOLOGY & PHARMACY International Journal of Pharmaceutics Pub Date : 2024-10-28 DOI:10.1016/j.ijpharm.2024.124883
Daniel Tristan Osanlóo , Denny Mahlin , Simon Bjerregaard , Björn Bergenståhl , Anna Millqvist-Fureby
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Abstract

This article compares and explores vacuum foam-drying as an alternative drying technology to freeze-drying and spray drying for a recombinant human lipase as the model protein. Materials characteristics such as structure, surface composition and the solid-state properties of the dry materials were compared and investigated. Moreover, the technical functionality in terms of reconstitution characteristics and the lipase stability were also investigated. The stability of the lipase was evaluated through activity measurements. Sucrose and dextran D40 (40 kDa) were used as matrix former and the surfactant α-dodecyl maltoside was used as surface active additive. The study demonstrated that the drying technique greatly influenced the material structure and composition which in turn affected the reconstitution characteristics. The lipase was overrepresented at the material surface in declining order spray-dried > vacuum foam-dried > freeze-dried. The lipase activity was retained up to 10 % lipase content in solids, but at 20 % lipase a loss of activity was observed for all drying techniques. Phase separation in the solid material may be an explanation. Vacuum foam-drying shows promise as an alternative drying technique for the lipase, and potentially other proteins.

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探索用真空泡沫干燥法替代冷冻干燥法和喷雾干燥法生产人类脂肪酶
本文以重组人脂肪酶为模型蛋白质,比较并探讨了真空泡沫干燥作为冷冻干燥和喷雾干燥的替代干燥技术。比较和研究了干燥材料的结构、表面成分和固态特性等材料特征。此外,还研究了重组特性和脂肪酶稳定性方面的技术功能。脂肪酶的稳定性是通过活性测定来评估的。蔗糖和右旋糖酐 D40(40 kDa)用作基质前体,表面活性剂 α-十二烷基麦芽糖苷用作表面活性添加剂。研究表明,干燥技术在很大程度上影响了材料的结构和组成,进而影响了复溶特性。按照喷雾干燥、真空发泡干燥和冷冻干燥的递减顺序,脂肪酶在材料表面的比例过高。脂肪酶的活性在固体中脂肪酶含量达到 10% 时仍能保持,但在脂肪酶含量达到 20% 时,所有干燥技术都会导致活性下降。固体材料中的相分离可能是一个原因。真空泡沫干燥技术有望成为脂肪酶以及其他潜在蛋白质的替代干燥技术。
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来源期刊
CiteScore
10.70
自引率
8.60%
发文量
951
审稿时长
72 days
期刊介绍: The International Journal of Pharmaceutics is the third most cited journal in the "Pharmacy & Pharmacology" category out of 366 journals, being the true home for pharmaceutical scientists concerned with the physical, chemical and biological properties of devices and delivery systems for drugs, vaccines and biologicals, including their design, manufacture and evaluation. This includes evaluation of the properties of drugs, excipients such as surfactants and polymers and novel materials. The journal has special sections on pharmaceutical nanotechnology and personalized medicines, and publishes research papers, reviews, commentaries and letters to the editor as well as special issues.
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