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
Declarations
Author contributions
The author contributed solely to the work.
Conflicts of interest
The author declares that he has no conflicts of interest.
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