Insulin Formulation Characterization—the Thioflavin T Assays
| Autor: | Morten Schlein |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
Amyloid medicine.medical_treatment Pharmaceutical Science Type 2 diabetes 010402 general chemistry 01 natural sciences 03 medical and health sciences Microtiter plate chemistry.chemical_compound Fibril formation medicine Humans Hypoglycemic Agents Insulin Benzothiazoles Fluorescent Dyes Chemistry Amyloid fibril medicine.disease 0104 chemical sciences Thiazoles 030104 developmental biology Diabetes Mellitus Type 2 Biochemistry Drug Design Biological Assay Physical stability Thioflavin Insulin products |
| Zdroj: | The AAPS Journal. 19:397-408 |
| ISSN: | 1550-7416 |
| DOI: | 10.1208/s12248-016-0028-6 |
| Popis: | The insulin molecule was discovered in 1921. Shortly thereafter, its propensity towards amyloid fibril formation, fibrillation, was observed and described in the literature as a "precipitate." In the past decades, the increased incidence of type 2 diabetes has reached global epidemic proportions. This has emphasized the demands for both insulin production and the development of modern insulin products for unmet medical needs. Bringing such new insulin drug products to the market for the benefit of patients requires that many CMC-related processes are understood, described, and controlled. One potential undesired process is insulin fibril formation. The compound thioflavin T (ThT) is known as a fluorescent probe for amyloid fibrils. As such, ThT is utilized in a versatile research assay in microtiter plate format, the ThT assay. This review will describe an experimental set-up using not only a ThT microtiter plate assay but also two orthogonal methods. The use of the ThT assay in research and characterization of insulin analogues, as well as formulations of insulin, is described by cases drawn from the scientific literature and patents. The ThT assay is compared to other physical stability tests and in conclusion the advantages and limitations of the assay are compared. |
| Databáze: | OpenAIRE |
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