JILL K. SHERWOOD,Joel Sequeira,Brent Ashley Donovan
申请号：
US13297866
公开号：
US20120055469A1
申请日:
2011.11.16
申请国别(地区):
US
年份:
2012
代理人:
摘要：
Various aspects of the present invention provide for methods of manufacturing a pharmaceutical drug product, which include storing a container at a temperature greater than ambient conditions for at least about seven days and conducting release testing on the container after storing. Products manufactured by this method have a more consistent fine particle size distribution (FSD) and fine particle fraction (FPF) at ambient conditions and at accelerated stability conditions over the life of the drug product. Advantageously, such products may more reliably and regularly pass testing requirements as required for an approved drug product by regulatory authorities such as the United States Food and Drug Administration (USFDA).
