Table 1.
Study target with CMAs and CPPs
| QTPP
|
CMAs
|
CPPs
|
||||||
|---|---|---|---|---|---|---|---|---|
| TPP | Target | TPQP | Material | Levels
|
Parameter | Levels
|
||
| −1 | +1 | −1 | +1 | |||||
| Route of administration | Oral | • Nontoxic Method of assessment: cytotoxicity studies |
PVP K30 concentration (%) |
1 | 2 | Sonicationtime (min) | 10 | 15 |
| Formulation type | Nanosuspension | • Particle size • PDI Method of assessment: PCS using Malvern Zetasizer • Particle shape and morphology Method of assessment: AFM |
PVA concentration (%) |
1 | 3 | |||
| Oral bioavailability | Enhancement of oral bioavailability | • In vitro drug release Method of assessment: USP type II apparatus • In vivo studies Method of assessment: indirect method for the assessment of drug in rat plasma |
||||||
Abbreviations: TPP, target product profile; TPQP, target product quality profile; QTPP, quality target product profile; CMA, critical material attribute; CPP, critical processing parameter; PDI, polydispersity index; AFM, atomic force microscopy; PVA, polyvinyl alcohol; PVP, polyvinylpyrrolidone; PCS, photon correlation spectroscopy; USP, United States Pharmacopeia.