Table 3.

Example of target product profiles (TPPs) for drug nanocrystals: case aceclofenac. Modified from [73].

TPPs	Target	CQAs
Dosage form	Oral capsule	Identity, assay, content uniformity
Microbial quality	No contamination	Test for microbial growth
Product performance	Robust manufacturing	Drug content, particle size, polydispersity, morphology, solid state form, in vitro drug release
Pharmacokinetic target efficacy and safety	Better pharmacokinetic profile than pure drug	Pharmacokinetic parameters (Tmax, Cmax, AUC, MRT)
Stability	Stable at least 3 months at accelerated storage conditions	Drug content, particle size and polydispersity of redispersed sample