Table 2 Quality Target Product Profile (QTPP) for niosomal formulation

Dosage form

Colloidal carrier drug delivery system

For targeted drug delivery with longer residence time in skin and relatively less systemic absorption

Dosage design

Niosomes

To provide a lipidic environment to the drug and to obtain a higher retention in the skin. Niosomes offer higher entrapment, better stability, and are less prone to leakage as compared to liposomes

Route of administration

Topical

For non-invasive drug delivery with minimal systemic absorption

Stability

Short term stability study at room temperature (25 °C, 60% RH) and refrigerated condition(4–8 °C) for 6 months

The product should have enough shelf life

Dosage product quality attribute

Physical attributes^a

Required for product efficacy and patient acceptability

% Entrapment efficiency

The higher the encapsulation efficiency, the better the yield during development and formulation is economic

Vesicle size and polydispersity index

Optimum vesicle size to efficiently penetrate the skin but also provide maximum skin retention and minimum systemic absorption. The smaller the PDI, the better uniformity and higher stability