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Your heat map
Particle morphology
Powder flow
Bulk density
Number of salts
Solid state complexity
Informatics assessment
Hygroscopicity
Melting point
- Green: It is unlikely to entail excessive cost
- Orange: It is unlikely to increase cost and complexity of development
- Red: It is very likely to increase cost and complexity of development
- Blue: Knowledge gap
Key takeaways
Factors that might hinder development and suggested mitigation
Particle Morphology
Aspect ratio and particle size can both be manipulated by using seeding and better control of supersaturation during the crystallisation.
Significant reduction in size can occur during agitated drying so limiting agitation on drying should be investigated.
If the problem challenges the ability to manufacture, then an alternate solid state form might be investigated.
Powder flow
Poor API flow may cause problems during formulation manufacture. The tactics used to decrease aspect ratio and increase particle size are also generally applicable to improving powder flow.
Aspect ratio and particle size can both be manipulated by using seeding and better control of supersaturation during the crystallisation.
Significant reduction in size can occur during agitated drying so limiting agitation on drying should be investigated.
If the problem significantly challenges the ability to manufacture, then an alternate solid state form might be investigated.
Bulk density
Higher bulk density powders will exhibit good flow and can be packed and transported efficiently.
Number of salts
If only a few salts have been identified, then the opportunity for a switch of salt form is limited. A more detailed solid state form screening is needed which may include cocrystals.
Solid state complexity
N/A
Informatics assessment
Any unusual packing motif or unknown hydrate or process relevant solvate identified in a computational assessment may need to be derisked
Hygroscopicity
If the API picks up significant water and may form hydrates, this may impact biopharmaceutics, stability and manufacturability.
Selection of a non-hygroscopic or hydrating solid state form would address this problem. If this isn’t possible, then process controls for hygroscopicity will need to be explored if there is an impact on manufacturability stability or biopharmaceutics.
Melting point
Low melting point solids may undergo process induced melting during formulation.
Melting point could be manipulated by selecting an alternate solid state form or by selecting formulation unit operations that do not create frictional heat.
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