CQAs of NLC with their justifications
| S. No. | Quality attributes of drug product | Target | CQA | Justification | |
|---|---|---|---|---|---|
| 1 | Physical attributes | ColorOdorAppearance | Acceptable to patientNo unpleasant odorAcceptable to patient | No | Color, odor, and appearance of the formulation were not considered critical as these do not affect the safety and efficacy of the drug. |
| 2 | Assay and drug content | 100% | No | Drug content and assay variability affect the safety and efficacy of the potent drug but as the drug is well-entrapped in the formulation as a homogenous blend with SL and LL, these quality attributes are moderately critical. | |
| 3 | PS | < 100 nm | Yes | A smaller size of the formulation is essential for lymphatic uptake and higher bioavailability of the drug and is therefore considered critical. | |
| 4 | Drug entrapment | High | Yes | Higher drug entrapment is critical as less excipients are required to coat the drug thus providing less exposure of excipients to patients. | |
| 5 | Drug release | High | Yes | Immediate drug release for quick action followed by sustained release of the drug for prolonged action was considered critical. | |
| 6 | Impurities | < 0.1% | Yes | Product related or process related impurities affects the safety of the formulation. | |
The value < 0.1% was set to prevent any toxic or unexpected side effects. This value can go higher than 0.1% if justified by toxicological data. PS: particle size; Should be less than 0.1% as per ICH Q3A guideline