Quality-by-design (QbD): an integrated approach for evaluation of powder blending process kinetics and determination of powder blending end-point

Journal of Pharmaceutical Sciences
Huiquan Wu, Mansoor A Khan

Abstract

The objective of this study was to develop an integrated process monitoring approach for evaluating powder blending process kinetics and determining blending process end-point. A mixture design was created to include 26 powder formulations consisting of ibuprofen as the model drug and three excipients (HPMC, MCC, and Eudragit L100-55). The mixer was stopped at various time points to enable near-infrared spectroscopy scan of the powder mixture for obtaining the time course of the blending process. The evaluation of the blending process kinetics and process end-point was studied through three quantitative approaches: (1) Spectra linear superposition method; (2) Characteristic peak method; (3) Moving block standard deviation method. It was found that the powder blending experienced an initial rapid process to reach a quasi- end point within the first few minutes. Afterwards, a demixing occurred. Then, a real blending end-point was reached as characterized by an inflection point. ANOVA shows that the compositions of ibuprofen and MCC are the most statistically significant variables that impact the time required to reach the blending end-point. This highlighted the critical importance of developing quantitative chemometric approache...Continue Reading

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Citations

May 24, 2014·The AAPS Journal·Lawrence X YuJanet Woodcock
Feb 1, 2011·Journal of Pharmaceutical Sciences·Frederick G Vogt, Alireza S Kord
May 20, 2015·Journal of Pharmaceutical Sciences·Otto ScheibelhoferJohannes G Khinast
Aug 7, 2013·Journal of Pharmaceutical Sciences·Firat YerlikayaYilmaz Capan
Nov 9, 2010·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Siegfried AdamJohannes G Khinast
Jul 9, 2014·International Journal of Pharmaceutics·Benoît IgneCarl A Anderson
May 20, 2014·International Journal of Pharmaceutics·Hiroshi NakagawaNaoki Wakiyama

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