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Quality-by-design: An integrated process analytical technology approach to determine the nucleation and growth mechanisms during a dynamic pharmaceutical coprecipitation process

✍ Huiquan Wu; Mansoor A. Khan 📂 Article 📅 2011 🏛 John Wiley and Sons 🌐 English ⚖ 595 KB

The objective of this study was to demonstrate the feasibility of using an integrated process analytical technology (PAT) approach to determine nucleation and growth mechanisms of a dynamic naproxen (drug)-Eudragit L100 (polymer) coprecipitation process. The influence of several thermodynamically im