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. 2020 Nov 6;12(11):1059. doi: 10.3390/pharmaceutics12111059

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