Opening book details…
Can I read Quality-by-design (QbD): Effects of testing parameters and formulation variables on the segregation tendency of pharmaceutical powder measured by the ASTM D 6940-04 segregation tester on EtoBox?
Quality-by-design (QbD): Effects of testing parameters and formulation variables on the segregation tendency of pharmaceutical powder measured by the ASTM D 6940-04 segregation tester by Lin Xie; Huiquan Wu; Meiyu Shen; Larry L. Augsburger; Robbe C. Lyon; Mansoor A. Khan; Ajaz S. Hussain; Stephen W. Hoag is a Chemistry article available to read on EtoBox.
What is Quality-by-design (QbD): Effects of testing parameters and formulation variables on the segregation tendency of pharmaceutical powder measured by the ASTM D 6940-04 segregation tester about?
The objective of this study was to examine the effects of testing parameters and formulation variables on the segregation tendency of pharmaceutical powders measured by the ASTM D 6940-04 segregation tester using design of experiments (DOE) approaches. The test blends consisted of 4% aspirin (ASP) and 96% microcrystalline cellulose (MCC) with and without magnesium stearate (MgS). The segregation tendency of a blend was determined by measuring the last/first (L/F) ratio, the ratio of aspirin concentrations between the first and last samples discharged from the tester. A 2(2) factorial design was used to determine the effects of measurement parameters [amount of material loaded (W), number of segregation cycles] with number of replicates 6. ANOVA showed that W was a critical parameter for segregation testing. The L/F value deviated further from 1 (greater segregation tendency) with increasing W. A 2(3) full factorial design was used to assess the effects of formulation variables: grade of ASP (unmilled, milled), grade of MCC, and amount of lubricant, MgS. MLR and ANOVA showed that the grade of ASP was the main effect contributing to segregation tendency. Principal Component Regressio
Who reads Quality-by-design (QbD): Effects of testing parameters and formulation variables on the segregation tendency of pharmaceutical powder measured by the ASTM D 6940-04 segregation tester?
It is typically read by researchers, students, and practitioners in Chemistry.
- Author
- Lin Xie; Huiquan Wu; Meiyu Shen; Larry L. Augsburger; Robbe C. Lyon; Mansoor A. Khan; Ajaz S. Hussain; Stephen W. Hoag
- Publisher
- John Wiley and Sons; Elsevier ; Elsevier Inc.; Elsevier BV (ISSN 0022-3549)
- Published
- 2008
- Language
- EN
- Field
- Chemistry (Physical Sciences)