TY - JOUR
T1 - Factors affecting defining the quality and functionality of excipients used in the manufacture of dry powder inhaler products
AU - Edge, Stephen
AU - Mueller, Stefan
AU - Price, Robert
AU - Shur, Jagdeep
PY - 2008/9
Y1 - 2008/9
N2 - The successful manufacture of a regulatory approved dry powder inhaler (DPI) product is only achievable by applying robust control systems to all aspects of analytical, engineering, and material based processes. Whilst many aspects of DPI drug product manufacturing can be adequately controlled, it is often the control of materials, that is, drug substance and excipients, which can lead to variation in the quality of the final drug product. This article gives an overview of DPI excipients and highlights the challenges of defining and, importantly, understanding the relationships between quality and functionality for excipient components in DPI formulations.
AB - The successful manufacture of a regulatory approved dry powder inhaler (DPI) product is only achievable by applying robust control systems to all aspects of analytical, engineering, and material based processes. Whilst many aspects of DPI drug product manufacturing can be adequately controlled, it is often the control of materials, that is, drug substance and excipients, which can lead to variation in the quality of the final drug product. This article gives an overview of DPI excipients and highlights the challenges of defining and, importantly, understanding the relationships between quality and functionality for excipient components in DPI formulations.
KW - Excipients
KW - Nebulizers and Vaporizers
KW - Powders
UR - http://dx.doi.org/10.1080/03639040802192814
U2 - 10.1080/03639040802192814
DO - 10.1080/03639040802192814
M3 - Article
C2 - 18800257
SN - 0363-9045
VL - 34
SP - 966
EP - 973
JO - Drug Development and Industrial Pharmacy
JF - Drug Development and Industrial Pharmacy
IS - 9
ER -