New aspects of developing a dry powder inhalation formulation applying the quality-by-design approach

Article ID	Journal	Published Year	Pages	File Type
5817507	International Journal of Pharmaceutics	2016	36 Pages	PDF

Keywords

Cmax QTPP FDA QbD tmax MDT LEU EMA CQA API RPM TPP PVP PVA CPP FPF PBS MMAD l-leucine European Medicines agency Pulmonary administration U.S. Food and Drug Administration Risk assessment Dry powder inhalation phosphate buffer maximum plasma concentration international council for harmonisation of technical requirements for pharmaceuticals for human use Mass median aerodynamic diameter Mean dissolution time REF target product profile quality target product profile Meloxicam ICH Active Pharmaceutical Ingredient Microcomposite Reference sample Critical quality attribute critical process parameter rotation per minute Fine particle fraction Quality by design

Related Topics

Health Sciences Pharmacology, Toxicology and Pharmaceutical Science Pharmaceutical Science

New aspects of developing a dry powder inhalation formulation applying the quality-by-design approach

Authors

Edina Pallagi, Keyhaneh Karimi, Rita Ambrus, Piroska Szabó-Révész, Ildikó Csóka,