Connecting QbD to Quality
Attributes
Analysis described in porosity, wetting and swelling
Solubility of excipients
Microscopic evaluation of swellability
Contact angle measurements
Bonding Index
Brittle Fracture Index
Compression force profile via simulation
Other mechanical properties
PS of excipients (match to API)
Hardness/
Brittleness of excipients
Granule strength
1st choice: wet granulation
2nd choice: direct comp.
3rd: dry granulation
1st choice: wet granulation
2nd choice: direct comp.
3rd: dry granulation
1st choice: wet granulation
2nd choice: direct comp.
3rd: dry granulation
1st choice: dry granulation
2nd choice: wet granulation/direct compression
1st choice: wet granulation
2nd choice: dry granulation
3rd: direct comp.
Counter ion selection
Polymorph selection
Analysis described in porosity, wetting and swelling
Counter ion selection
Polymorph selection
Solubility of API form
Microscopic evaluation of swellability
Contact angle measurements
Bonding Index
Brittle Fracture Index
Compression force profile via simulation
Other mechanical properties
PS of API (match to excipients)
Hardness/
Brittleness of API
Crystallization/
Milling – shape/size
Crystallization/
Milling – mechanical property; shape/size
*use DP excipient selection
measurements to facilitate DP process selection