Power of experimental design studies for the validation of pharmaceutical processes: Case study of a multilayer tablet manufacturing process

Drug Development and Industrial Pharmacy

Volumn 28, Issue 7, 2002, Pages 841-848

  Goutte, F ^a   Guemguem, F ^a   Dragan, C ^a   Vergnault, G ^a   Wehrle P ^b  

^a SkyePharma AG   (Switzerland)

^b UNIVERSITÉ DE STRASBOURG   (France)

Author keywords

Compression; Experimental design; Granulation; Multilayer tablet; Pharmaceutical process; Validation

Indexed keywords

DRUG; DRUG DERIVATIVE; ISOSORBIDE 5 NITRATE; ISOSORBIDE DINITRATE; ISOSORBIDE-5-MONONITRATE;

ALGORITHM; ARTICLE; DRUG INDUSTRY; DRUG MANUFACTURE; EXPERIMENTAL DESIGN; METHODOLOGY; TABLET COMPRESSION; TABLET FORMULATION; TABLET MANUFACTURE; VALIDATION PROCESS; CHEMISTRY; STANDARD; TABLET;

CHEMISTRY, PHARMACEUTICAL; DRUG INDUSTRY; ISOSORBIDE DINITRATE; RESEARCH DESIGN; TABLETS;

EID: 0036025245     PISSN: 03639045     EISSN: None     Source Type: Journal    
DOI: 10.1081/DDC-120005630     Document Type: Article

References (10)

1. Design of experiments for process validation
2. Statistical tools for process control and quality improvement in the pharmaceutical industry
3. Process control and scale-up of pharmaceutical wet granulation processes: A review
4. Identification of critical formulation and processing variables for metoprolol tartrate extended-release (ER) matrix tablets
5. Factor influence studies, applications of full and fractional designs at 2 levels
6. Multi-layer tablets as drug delivery device
7. Modulation of the dissolution profiles from Geomatrix® multi-layer matrix tablets containing drugs of different solubility