Development of a high-throughput UHPLC-MS-based content uniformity method as a tool for assessing dry powder inhalers.
BACKGROUND
Dry powder inhaler (DPI) product manufacturing requires the assessment of uniformity at various stages of the manufacturing process.


RESULTS
To efficiently and precisely determine the uniformity of the small doses inherent to DPI technology, an ultrahigh-performance liquid chromatography-mass spectrometry (UHPLC-MS)-based content uniformity method was developed. Using mathematical modeling and proper selection of bracketing standards, a volumetric approximation of sample weight was utilized, eliminating the need for accurate sample weights and reducing sample preparation time.


CONCLUSIONS
UHPLC-MS coupled with mathematical modeling makes high-throughput CU testing of DPI drug products possible which allows for an enhanced understanding of the manufacturing process.
Medendorp
Joseph
J
Schering-Plough Research Institute, Oral and Specialty Product Development, Summit, NJ 07901, USA.
Donovan
Brent
B
Pennington
Justin
J
D000280:Administration, Inhalation; D002851:Chromatography, High Pressure Liquid; D057166:High-Throughput Screening Assays; D013058:Mass Spectrometry; D008962:Models, Theoretical; D009330:Nebulizers and Vaporizers; D011208:Powders; D013678:Technology, Pharmaceutical
D011208:Powders