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
