Liposome Drug analysis

Liposomes as drug delivery systems exhibit different distribution and pharmacokinetics than free drug molecules. As for all other drug applications validated bioanalytical methods should be available when evaluating the pharmacokinetics and bioavailability of a liposome drug.

Additional validation work and stability investigations

Separation of capsulated and unencapsulated drug

• A second assay needs to be validated, one for the encapsulated drug and the other for the unencapsulated drug.
• A more sensitive method is required for the unencapsulated drug and even more challenging for the free non-protein bound drug.
• Additional QC samples with encapsulated drug to investigate matrix effects.
• Freeze-and-thaw cycles may change the free drug concentration.
• Bench top stability (release) of the liposomal drug in matrix.