The challenge of drying method selection for protein pharmaceuticals: product quality implications.

Abdul-Fattah AM; Kalonia DS; Pikal MJ

首页> 外文期刊>Journal of pharmaceutical sciences. >The challenge of drying method selection for protein pharmaceuticals: product quality implications.

【24h】

The challenge of drying method selection for protein pharmaceuticals: product quality implications.

机译：蛋白质药物干燥方法选择的挑战：产品质量的影响。

获取原文

获取原文并翻译 | 示例

掌桥外文数据库（机构版） >>

开具论文收录证明 >>

文献代查 >>

页面导航

摘要
著录项
相似文献
相关主题

摘要

Numerous drying methods are used to dry solutions of proteins in the laboratory and/or in pharmaceutical manufacturing. In this review article, we will discuss many of these drying methods. We will briefly introduce and compare the unit operations involved in the drying methods to give an insight on thermal history, and the different stresses that a drying method can present to an active ingredient, particularly for protein molecules. We will review and compare some important physico-chemical properties of the dried powder that result from using different drying methods such as specific surface area, molecular dynamics, secondary structure (for protein molecules), and composition heterogeneity. We will discuss some factors that might lead to differences in the physico-chemical properties of different powders of the same formulation prepared by different techniques. We will examine through a literature review how differences in some of these properties can affect storage stability. Also, we will review process modifications of the basic drying methods and how these modifications might impact physico-chemical properties, in-process stability and/or storage stability of the dried powders.

机译：在实验室和/或制药生产中，许多干燥方法用于干燥蛋白质溶液。在这篇评论文章中，我们将讨论许多这些干燥方法。我们将简要介绍和比较干燥方法中涉及的单元操作，以深入了解热历史以及干燥方法可能对活性成分（特别是蛋白质分子）产生的不同压力。我们将审查和比较由于使用不同的干燥方法而产生的干粉的一些重要物理化学性质，例如比表面积，分子动力学，二级结构（对于蛋白质分子）和组成异质性。我们将讨论一些因素，这些因素可能导致通过不同技术制备的同一配方的不同粉末的物理化学性质不同。我们将通过文献综述来研究其中某些特性的差异如何影响存储稳定性。另外，我们将审查基本干燥方法的工艺改进，以及这些改进如何影响干粉的理化性质，工艺稳定性和/或储存稳定性。

著录项

来源
《Journal of pharmaceutical sciences.》 |2007年第8期|共31页
作者
Abdul-Fattah AM; Kalonia DS; Pikal MJ;
展开▼
作者单位

展开▼
收录信息
原文格式 PDF
正文语种 eng
中图分类药学;
关键词
Desiccation; Proteins; Assault by stabbing; Review Publication Type; chemical properties; 干燥法; 蛋白质类;

机译：Desiccation;Proteins;Assault by stabbing;Review [Publication Type];chemical properties;干燥法;蛋白质类;

相似文献

外文文献
中文文献
专利

1. The challenge of drying method selection for protein pharmaceuticals: product quality implications. [J] . Abdul-Fattah AM, Kalonia DS, Pikal MJ Journal of pharmaceutical sciences. . 2007,第8期

机译：蛋白质药物干燥方法选择的挑战：产品质量的影响。
2. The nonsteady state modeling of freeze drying: in-process product temperature and moisture content mapping and pharmaceutical product quality applications. [J] . Pikal MJ, Cardon S, Bhugra C, Pharmaceutical development and technology . 2005,第1期

机译：冷冻干燥的非稳态建模：过程中产品温度和水分含量图以及药品质量应用。
3. Generic method for systematic phase selection and method development of biochromatographic processes - Part I. Selection of a suitable cation-exchanger for the purification of a pharmaceutical protein [J] . Lohrmann M, Schulte M, Strube J Journal of chromatography, A: Including electrophoresis and other separation methods . 2005,第1期

机译：系统相选择的通用方法和生物色谱方法的方法开发-第一部分。用于纯化药物蛋白的合适阳离子交换剂的选择
4. Effects of different drying methods on the product quality and drying kinetics of banana slices [C] . American Society of Agricultural and Biological Engineers Annual International Meeting . 2019

机译：不同干燥方法对香蕉切片产品质量及干燥动力学的影响
5. Evaluating energy efficient strategies and product quality for distillers' dried grains with solubles (DDGS) in dry-grind ethanol plants [D] . Lan, Tian. 2011

机译：评估干磨乙醇工厂中酒糟含可溶物（DDGS）的节能策略和产品质量
6. Finite Element Method (FEM) Modeling of Freeze-drying: Monitoring Pharmaceutical Product Robustness During Lyophilization [O] . Xiaodong Chen, Vikram Sadineni, Mita Maity, 2015

机译：冷冻干燥的有限元方法（FEM）建模：冻干过程中监测药品的坚固性
7. ABSTRACTudThe purpose of this research is to obtain an optimal formulations of Black mulberry leaves dried noodle product by using Design Expert Application with Design Mixture D-optimal method.udThis research was done with two phases. The preliminary procedures research is to determine levels of antioxidant activity, chlorophyll content, and the levels of tannin that was contained in black mulberry leaves, the black mulberry leaf flour, a pare fruits, and pare flour. Primary research is to determine the best formulation by using a Mixture Design Expert Design D-optimal method, for a purpose is to optimized the Black mulberry leaf dry noodle. Responses in this studies are a chemical analysis response by using a crude fiber analysis and protein analysis. Physical response is water absorption. Sensory response are color, flavor, and odor.udBlack mulberry leaves dried noodles was made from wheat flour, black mulberry leaf flour, and pare flour, other materials such as an eggs, water, salt, and sodium bicarbonate, of the 16 formulations that has offered to produce an optimal formulation based on desirability which contains 39.69 Flour,14.25 Black Mulberry Leaves flour, 3.06 Pare fruit and flour amounted, and other materials are 30 water, 10 eggs, 2 salt, and 1 sodium bicarbonate. The formulation has been result by program 11,05 crude fiber content, 12.93 protein, 274.31 water absorption, 4,31 for color attribute, 3,87 for taste attribute, and 3,71 for aroma attribute.ududKeyword: Black mulberry leaf dried noodles, optimization. [O] . Leti Nurlatifah Alumni, Yudi Garnida DS, Tantan Widiantara DS 2017

机译：抽象 ud本研究的目的是通过使用带有Design Mixture D-最优方法的Design Expert Application获得黑桑叶干面条产品的最佳配方。 ud这项研究分两个阶段进行。初步程序研究是确定抗氧化剂活性，叶绿素含量以及黑桑叶，黑桑叶粉，果皮和果皮中所含单宁的含量。首要研究是通过使用Mixture Design Expert Design D-optimal方法确定最佳配方，目的是优化黑桑叶干面条。本研究中的反应是通过使用粗纤维分析和蛋白质分析进行的化学分析反应。物理反应是吸水。感官反应是颜色，味道和气味。黑桑叶干面条由小麦粉，黑桑叶粉和削皮粉，鸡蛋，水，盐和碳酸氢钠等其他材料制成，这16种配方可根据需要提供最佳配方其中包含39.69％的面粉，14.25％的黑桑叶面粉，3.06％的去皮水果和面粉，其他材料是30％的水，10％的鸡蛋，2％的盐和1％的碳酸氢钠。该配方是通过程序11,05％的粗纤维含量，12.93％的蛋白质，274.31％的吸水率，4.31的颜色属性，3,87的味道属性和3,71的芳香属性得出的。 ud关键字：黑桑叶干面条，优化。

The challenge of drying method selection for protein pharmaceuticals: product quality implications.

摘要

著录项

相似文献

相关主题

期刊订阅