Monitoring process induced attrition of drug substance particles within formulated blends.
作者： John F. Gamble , Magnus Hoffmann , Helen Hughes , Paul Hutchins , Mike Tobyn
DOI: 10.1016/J.IJPHARM.2014.04.028
关键词:
摘要: Abstract The aim of the study was to investigate impact unit processing steps such as blending, cone milling and powder feeding systems on particle size a formulated API. properties single component (API) within samples were tracked using an image based characterisation system with integrated Raman probe. In addition primary aim, excipient selection also assessed. demonstrated ability track shape particles blended system. Process induced attrition can affect significant changes in characteristics API particles. Whilst blending found have minimal properties, through transmission formulations excipients blends propensity observed be low. findings suggest that for undergo process should taken into consideration when designing manufacturing and/or relating initial performance intermediate or final dosage forms.
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