Influence and effect of osmolytes in biopharmaceutical formulations
| Autor: | Gisele Monteiro, Samarina Rodrigues Wlodarczyk, Débora Fernandes Custodio, Adalberto Pessoa |
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| Rok vydání: | 2018 |
| Předmět: |
0301 basic medicine
Drug VACINAS Drug Compounding media_common.quotation_subject Pharmaceutical Science 02 engineering and technology Protein aggregation Biopharmaceutics Organic molecules Excipients 03 medical and health sciences Animals Humans Denaturation (biochemistry) Amino Acids media_common chemistry.chemical_classification Chemistry General Medicine 021001 nanoscience & nanotechnology Amino acid Folding (chemistry) 030104 developmental biology Biopharmaceutical Biochemistry Osmolyte 0210 nano-technology Biotechnology |
| Zdroj: | Repositório Institucional da USP (Biblioteca Digital da Produção Intelectual) Universidade de São Paulo (USP) instacron:USP |
| ISSN: | 0939-6411 |
| DOI: | 10.1016/j.ejpb.2018.07.019 |
| Popis: | Osmolytes are small organic molecules accumulated by cells in response to environmental stresses. They are represented by amino acids, sugars, polyols, tertiary sulphonium and quaternary ammonium compounds. These molecules present a protective behaviour and favour the equilibrium of macromolecules towards the native form, preventing denaturation and promoting the folding of unfolded proteins. Protein formulations due to their biological character require greater care during the manufacturing process, shelf-life and administration of the drug, as variations in these factors may result in denaturation, inactivation and/or protein aggregation. These drawbacks can be surpassed using osmolytes as excipients in protein formulations as stabilisers, bulking agents and even buffers. A number of 133 biologics, including vaccines and immunoglobulins, approved by the U.S. Food and Drug Administration (FDA) between 1998 and 2017 were analysed in this work in order to identify the most used group of osmolyte molecules. A deep insight into their role in protein formulations was discussed and compared to data in the literature. The advantages and disadvantages of their use in specific formulations were also extensively discussed here. In conclusion, investigation into the role of osmolytes in each formulation is essential for understanding their effect and provides a background to be used when selecting the best osmolyte to fit a specific formulation without excluding the patient needs. |
| Databáze: | OpenAIRE |
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