Table 1.
Elements of the quality target product profile (QTPP) and critical quality attribute (CQA) for the development of the atazanavir-nanostructured lipid carrier (ATZ-NLC).
| QTPP | ||
| QTPP | Target | Justification |
| Drug delivery system | Nanostructured lipid carriers | Offers augmentation in oral bioavailability |
| Dosage type | Controlled release | Enhanced drug absorption will be achieved |
| Route of administration | Oral | Patient compliant route offering lymphatic uptake. |
| Drug release | More than 80% | Essential for attained optimal therapeutic activity |
| CQA | ||
| CQA | Target | Justification |
| Particle size | Less than 250 nm | Absorption and bioavailability are improved |
| Entrapment efficiency | More than 70% | Improved therapeutic outcome and pharmacological activity. |
| Drug loading | More than 8% | Improved therapeutic outcome and pharmacological activity |