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1.
Pharm Res ; 24(10): 1854-61, 2007 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-17484041

RESUMO

PURPOSE: Water content and granule size are recognized as critical process and product quality parameters during drying. The purpose of this study was to enlighten the granule behavior during fluid bed drying by monitoring the major events i.e. changes in water content and granule size. METHODS: NIR spectra collected during drying and water content of sampled granules were correlated by principal component analysis (PCA) and partial least squares regression (PLSR). NIR spectra of dried granules were correlated to median granule size in a second PCA and PLSR. RESULTS: The NIR water model discriminates between various stages in fluid-bed drying. The water content can be continuously predicted with errors comparable to the reference method. The four PLS factors of the granule size model are related to primary particle size of lactose, median granule size exceeding primary particle size and amorphous content of granules. The small prediction errors enable size discrimination between fines and granules. CONCLUSION: For product quality reasons, discrimination between drying stages and end-point monitoring is highly important. Together with the possibilities to determine median granule size and to distinguish fines this approach provides a tool to design an optimal drying process.


Assuntos
Dessecação , Excipientes/química , Lactose/química , Espectroscopia de Luz Próxima ao Infravermelho , Tecnologia Farmacêutica/métodos , Água/análise , Excipientes/normas , Lactose/normas , Análise dos Mínimos Quadrados , Modelos Químicos , Tamanho da Partícula , Pós , Análise de Componente Principal , Controle de Qualidade
2.
Biomacromolecules ; 8(6): 1775-89, 2007 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-17444679

RESUMO

In the past few years, protein biochips have emerged as promising proteomic and diagnostic tools for obtaining information about protein functions and interactions. Important technological innovations have been made. However, considerable development is still required, especially regarding protein immobilization, in order to fully realize the potential of protein biochips. In fact, protein immobilization is the key to the success of microarray technology. Proteins need to be immobilized onto surfaces with high density in order to allow the usage of small amount of sample solution. Nonspecific protein adsorption needs to be avoided or at least minimized in order to improve detection performances. Moreover, full retention of protein conformation and activity is a challenging task to be accomplished. Although a large number of review papers on protein biochips have been published in recent years, few have focused on protein immobilization technology. In this review, current protein immobilization strategies, including physical, covalent, and bioaffinity immobilization for the fabrication of protein biochips, are described. Particular consideration has been given to oriented immobilization, also referred to as site-specific immobilization, which is believed will improve homogeneous surface covering and accessibility of the active site.


Assuntos
Análise Serial de Proteínas , Proteínas/química , Animais , Biotina/química , Enzimas Imobilizadas/química , Humanos , Substâncias Macromoleculares , Modelos Químicos , Conformação Molecular , Peptídeos/química , Conformação Proteica , Proteômica/instrumentação , Propriedades de Superfície
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