QTPP of NLC
| S. No. | QTPP | Target | Justification |
|---|---|---|---|
| 1 | Dosage form | Lipid based formulation | Selection of NLC, which is lipid based enhances the oral bioavailability of lipid soluble, BCS class II drugs |
| 2 | Dosage shape | Spherical | High surface area, high rate of drug release |
| 3 | Dosage type | Controlled release | Low dosing frequency |
| 4 | Dosage strength | X (mg) | Required dose to be incorporated in formulation to provide therapeutic benefit |
| 5 | Pharmacokinetics | Cmax, AUC | High AUC and Cmax are required to achieve higher plasma drug concentration and thus higher oral bioavailability |
| 6 | Route of administration | Oral | Good patient compliance, non-invasive |
| 7 | Container and closure | Air-tight amber color bottle | To protect drug degradation from light and moisture |
| 8 | Stability | At least 12 months at room temperature | To maintain the therapeutic activity of the drug during the storage period |
AUC: area under curve; BCS: biopharmaceutical classification system; Cmax: maximum plasma concentration; S. No.: serial number
The author contributed solely to the work.
The author declares that he has no conflicts of interest.
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© The Author(s) 2022.