Effect of Atomic Layer Coating on the Stability of Solid Myoglobin Formulations

IF 4.5 2区医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL

Molecular Pharmaceutics Pub Date : 2023-07-19 DOI:10.1021/acs.molpharmaceut.3c00229

Caio H. N. Barros, Manuel Alfaro, Cormac Costello, Fei Wang, Kedar Sapre, Suneel Rastogi, Shivkumar Chiruvolu, James Connolly and Elizabeth M. Topp*,

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Abstract

The effects of atomic layer (ALC) coating on physical properties and storage stability were examined in solid powders containing myoglobin, a model protein. Powders containing myoglobin and mannitol (1:1 w/w) were prepared by lyophilization or spray drying and subjected to aluminum oxide or silicon oxide ALC coating. Uncoated samples of these powders as well as coated and uncoated samples of myoglobin as received served as controls. After preparation (t₀), samples were analyzed for moisture content, reconstitution time, myoglobin secondary structure, crystallinity, and protein aggregate content. Samples were stored for 3 months (t₃) under controlled conditions (53% RH, 40 °C) in both open and closed vials and then analyzed as above. At t₃, the recovery of soluble native (i.e., monomeric) protein depended on formulation, coating type, and drying method and was up to 2-fold greater in coated samples than in uncoated controls. Promisingly, some samples with high recovery also showed low soluble aggregate content (<10%) at t₃ and low total monomer loss; the latter was correlated to sample moisture content. Overall, the results demonstrate that ALC coatings can stabilize solid protein formulations during storage, providing benefits over uncoated controls.

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原子层涂层对固体肌红蛋白配方稳定性的影响

研究了原子层(ALC)涂层对含有肌红蛋白(一种模型蛋白)的固体粉末的物理性能和贮存稳定性的影响。采用冻干或喷雾干燥法制备含有肌红蛋白和甘露醇(1:1 w/w)的粉末，并进行氧化铝或氧化硅ALC涂层。这些粉末的未涂覆样品以及所收到的涂覆和未涂覆的肌红蛋白样品作为对照。制备(0)后，对样品进行水分含量、重构时间、肌红蛋白二级结构、结晶度和蛋白质聚集体含量的分析。样品在受控条件下(53% RH, 40°C)在开放和封闭小瓶中保存3个月(t3)，然后按上述方法进行分析。在t3时，可溶性天然蛋白(即单体)的回收率取决于配方、包衣类型和干燥方法，包衣样品的回收率比未包衣对照高2倍。有希望的是，一些高回收率的样品在t3时也表现出低可溶性骨料含量(<10%)和低总单体损失率;后者与样品含水量相关。总的来说，结果表明，ALC涂层可以在储存过程中稳定固体蛋白质配方，比未涂层的对照组更具优势。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Molecular Pharmaceutics 医学-药学

CiteScore

8.00

自引率

6.10%

发文量

391

审稿时长

2 months

期刊介绍： Molecular Pharmaceutics publishes the results of original research that contributes significantly to the molecular mechanistic understanding of drug delivery and drug delivery systems. The journal encourages contributions describing research at the interface of drug discovery and drug development. Scientific areas within the scope of the journal include physical and pharmaceutical chemistry, biochemistry and biophysics, molecular and cellular biology, and polymer and materials science as they relate to drug and drug delivery system efficacy. Mechanistic Drug Delivery and Drug Targeting research on modulating activity and efficacy of a drug or drug product is within the scope of Molecular Pharmaceutics. Theoretical and experimental peer-reviewed research articles, communications, reviews, and perspectives are welcomed.