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Multivariate methods in the development of a new tablet formulation : optimization and validation
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- Gabrielsson, Jon (author)
- Umeå universitet,Kemiska institutionen,Research Group for Chemometrics
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- Lindberg, Nils-Olof (author)
- Pharmacia AB, Consumer Healthcare, Helsingborg, Sweden
- Pålsson, Magnus (author)
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- (creator_code:org_t)
- New York : M. Dekker, 2004
- 2004
- English.
- In: Drug Development and Industrial Pharmacy. - New York : M. Dekker. - 0363-9045 .- 1520-5762. ; 30:10, s. 1037-1049
- Journal article (peer-reviewed)
Abstract
Subject headings
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- In a previous study of the development of a tablet formulation approximately 100 excipients were characterized in screening experiments using multivariate design. Acceptable values for important responses were obtained with some of the formulations. The relationships between the properties of the excipients and the responses were evaluated using PLS. In this study additional experiments were performed in order to validate models obtained from the screening study and to find a formulation of suitable composition with desired tablet properties. A formulation with the desired disintegration time was found with the additional experiments and the agreement between observed and predicted values was fair for the tablets that did disintegrate. A limitation of this study was that tablets from four experiments did not disintegrate within the set time limit. The lack of agreement between observed and predicted values of these four experiments was probably due to the nature of one of the factors in the design. Considering the reduced experimental design the results are still encouraging.
Subject headings
- NATURVETENSKAP -- Kemi (hsv//swe)
- NATURAL SCIENCES -- Chemical Sciences (hsv//eng)
Keyword
- Multivariate design
- Validation
- Disintegration time
- PCA
- PLS
Publication and Content Type
- ref (subject category)
- art (subject category)
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