2. Guidance for Extractable Study on Packaging System of Inhalation Aerosols(Draft for Comments)参考资料说明.pdfVIP

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2. Guidance for Extractable Study on Packaging System of Inhalation Aerosols(Draft for Comments)参考资料说明.pdf

GuidanceforExtractableStudyon

PackagingSystemofInhalationAerosols

(DraftforComments)

Introduction

Aninhalationdrugcombinesthecharacteristicsofinhaled

formulationsandaerosols,whileinteractionbetweenthedrug

formulationandpackagingsystembearsthehighestlevelof

risk.Inhaledaerosoldrugformulationsaremainlybasedonorganic

mediaphase,andthepackagingsystemhasacomplicatedstructure,

involvingplastics,rubber,metalandothermaterials.Thesefactors

determinethatinhalationaerosolpackagingsystemanddrug

compatibi

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