An Evaluation of Process Variables in wet Granulation

Autor: Yousuke Miyamoto, H. Stoa, Satoshi Ogawa, Kozo Takayama, Masaharu Miyajima, Tsuneji Nagai
Rok vydání: 1995
Předmět:
Zdroj: Drug Development and Industrial Pharmacy. 21:2213-2225
ISSN: 1520-5762
0363-9045
DOI: 10.3109/03639049509065902
Popis: In wet granulation, determining the process variables which play an essential role in granule quality is crucial for optimizing the manufacturing process. An L16(25) fractional factorial experimental design using the table of orthogonal arrays was employed in order to estimate the relative intensity of the influences of five process variables on granule quality in wet granulation using a high-speed mixer granulator. Total volume and formulation of binder solution, blade rotation speed, granulation time, and amount of powder supplied into the granulator were selected as decisive process variables in the formation of granules. Granule yield, geometrical mean granule size and uniformity of granule size were evaluated as representative properties of granule quality. Experimental results were analyzed according to the analysis of variance (ANOVA).The results of significance test and contribution ratio in ANOVA indicated that, within the experimental region, only binder solution had a critical effect on...
Databáze: OpenAIRE