MDI and DPI is a critical pharmaceutical dosage form due to its manufacturing criticality and site of action. The basic difference between MDI and DPI is - MDI is propellant based where DPI is propellant free. Here we try to mention the common CPP and CQA of MDI and DPI.


Critical Process Parameters (Premix)

  • Order of raw material addition
  • Homogenizer speed
  • Mixing time


Critical Quality Attributes (Premix)

  • Appearance


Critical Process Parameters  (Formulation)

  • Quantity of HFA
  • Order of raw material addition
  • Mixing time and speed
  • Vessel size and inside pressure
  • Product temperature


Critical Quality Attributes (Formulation)

  • Appearance
  • Identification 
  • Assay


Critical Process Parameters (Filling)

  • Recirculation time
  • Filled Volume of suspension 
  • Filled volume of HFA
  • HFA transferring pressure
  • Crimping height and diameter 
  • Product temperature


Critical Quality Attributes (Filling)

  • Appearance
  • Identification
  • Average weight of expelled per puff
  • Average filled wt. per canister
  • No of puff per canister
  • Uniformity of delivered dose
  • Deposition of emitted dose
  • Aerodynamic particle size
  • Related substances
  • Microbial contamination test
  • Assay


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