Peptide Isolation via Spray Drying: Particle Formation, Process Design and Implementation for the Production of Spray Dried Glucagon
| Autor: | Rebecca L. Davis-Harrison, Alastair J. Florence, Jeremy Hinds, Scott Alan Frank, Frederik J.S. Doerr, Lee J. Burns, Becky Lee |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
RM
psychrometric process model Materials science Process analytical technology Pharmaceutical Science Process design 02 engineering and technology 010402 general chemistry 01 natural sciences peptide formulation Excipients Protein Aggregates Drug Stability Technology Pharmaceutical Pharmacology (medical) spray drying Process engineering Pharmacology Protein Stability Economies of agglomeration business.industry droplet drying Organic Chemistry Trehalose Glucagon 021001 nanoscience & nanotechnology process development 0104 chemical sciences Freeze Drying Scientific method Spray drying Molecular Medicine Degradation (geology) Particle Particle size Powders 0210 nano-technology business Research Paper Biotechnology |
| Zdroj: | Pharmaceutical Research |
| ISSN: | 1573-904X 0724-8741 |
| Popis: | Purpose Spray drying plays an important role in the pharmaceutical industry for product development of sensitive bio-pharmaceutical formulations. Process design, implementation and optimisation require in-depth knowledge of process-product interactions. Here, an integrated approach for the rapid, early-stage spray drying process development of trehalose and glucagon on lab-scale is presented. Methods Single droplet drying experiments were used to investigate the particle formation process. Process implementation was supported using in-line process analytical technology within a data acquisition framework recording temperature, humidity, pressure and feed rate. During process implementation, off-line product characterisation provided additional information on key product properties related to residual moisture, solid state structure, particle size/morphology and peptide fibrillation/degradation. Results A psychrometric process model allowed the identification of feasible operating conditions for spray drying trehalose, achieving high yields of up to 84.67%, and significantly reduced levels of residual moisture and particle agglomeration compared to product obtained during non-optimal drying. The process was further translated to produce powders of glucagon and glucagon-trehalose formulations with yields of >83.24%. Extensive peptide aggregation or degradation was not observed. Conclusions The presented data-driven process development concept can be applied to address future isolation problems on lab-scale and facilitate a systematic implementation of spray drying for the manufacturing of sensitive bio-pharmaceutical formulations. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full text from SpringerLink