Doehlert experimental design applied to optimization and quality control of a granulation process in a high shear mixer

A quality control study on a placebo granulation prepared in a 10 1 high shear mixer was carried out using a Doehlert design with the introduction of a noise factor (impeller speed). The response surface methodology was used to find the operating conditions leading to a product whose characteristics...

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Bibliographic Details
Published in:International journal of pharmaceutics 1996-12, Vol.145 (1), p.203-213
Main Authors: Vojnovic, D., Chicco, D., El Zenary, H.
Format: Article
Language:English
Subjects:
Analysis
Biological and medical sciences
Doehlert design
General pharmacology
Granulation
High shear mixer
Medical sciences
Pharmacology. Drug treatments
Quality control
Scale-up
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Description
Summary:A quality control study on a placebo granulation prepared in a 10 1 high shear mixer was carried out using a Doehlert design with the introduction of a noise factor (impeller speed). The response surface methodology was used to find the operating conditions leading to a product whose characteristics are not only included in the target range, but also non-sensitive to impeller speed variations. Based on the fact that the impeller speed is an important noise factor in the scale-up process, the above-mentioned operating conditions were chosen for preparation of the granules in 50 1 high shear mixer. The tested operating conditions proved suitable for scaling-up from 10 to 50 1.
ISSN:0378-5173
1873-3476
DOI:10.1016/S0378-5173(96)04771-0