Document Detail


A Model-Based Methodology for Spray-Drying Process Development.
MedLine Citation:
PMID:  20234866     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Solid amorphous dispersions are frequently used to improve the solubility and, thus, the bioavailability of poorly soluble active pharmaceutical ingredients (APIs). Spray-drying, a well-characterized pharmaceutical unit operation, is ideally suited to producing solid amorphous dispersions due to its rapid drying kinetics. This paper describes a novel flowchart methodology based on fundamental engineering models and state-of-the-art process characterization techniques that ensure that spray-drying process development and scale-up are efficient and require minimal time and API. This methodology offers substantive advantages over traditional process-development methods, which are often empirical and require large quantities of API and long development times. This approach is also in alignment with the current guidance on Pharmaceutical Development Q8(R1). The methodology is used from early formulation-screening activities (involving milligrams of API) through process development and scale-up for early clinical supplies (involving kilograms of API) to commercial manufacturing (involving metric tons of API). It has been used to progress numerous spray-dried dispersion formulations, increasing bioavailability of formulations at preclinical through commercial scales.
Authors:
Dan E Dobry; Dana M Settell; John M Baumann; Rod J Ray; Lisa J Graham; Ron A Beyerinck
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2009-7-25
Journal Detail:
Title:  Journal of pharmaceutical innovation     Volume:  4     ISSN:  1939-8042     ISO Abbreviation:  -     Publication Date:  2009 Sep 
Date Detail:
Created Date:  2010-3-17     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101392207     Medline TA:  J Pharm Innov     Country:  -    
Other Details:
Languages:  ENG     Pagination:  133-142     Citation Subset:  -    
Affiliation:
Bend Research Inc., 64550 Research Road, Bend, OR 97701 USA.
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