Power of Experimental Design Studies for the Validation of Pharmaceutical Processes: Case Study of a Multilayer Tablet Manufacturing Process

Autor:	F. Goutte, F. Guemguem, C. Dragan, P. Wehrlé, G. Vergnault
Rok vydání:	2002
Předmět:	Pharmacology Drug Industry Process (engineering) Computer science business.industry Manufacturing process Chemistry Pharmaceutical Organic Chemistry Pharmaceutical Science Isosorbide Dinitrate Power (physics) Design studies Multilayer tablet Research Design Drug Discovery Key (cryptography) Process optimization Process engineering business Tablets Pharmaceutical industry
Zdroj:	Drug Development and Industrial Pharmacy. 28:841-848
ISSN:	1520-5762 0363-9045
DOI:	10.1081/ddc-120005630
Popis:	Experimental design studies (EDS) are already widely used in the pharmaceutical industry for drug formulation or process optimization. Rare are the situations in which this methodology is applied for validation purposes. The power of this statistical tool, key element of a global validation strategy, is demonstrated for a multilayer tablet manufacturing process. Applied to the Geomatrix® system generally composed of one compression and three granulation processes, time and strictness gains are non-negligible. Experimental design studies are not used in this work for modeling. Introduced at each important step of the process development, they allow for the evaluation of process ruggedness at pilot scale and specifications for full production. A demonstration of the complete control of key process parameters is given, identified throughout preliminary studies.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::855e4b3e5603eeece6ad8f854d8b5731 https://doi.org/10.1081/ddc-120005630 Zobrazit plný text záznamu Plný text ve formátu PDF Plný text ve formátu HTML
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