Table 2.
Main experimental studies of AmB-loaded liposomes to treat CL.
| Composition | Permeation Studies Outcomes | Animal Model (Dose, Regimen) |
In Vivo Outcomes | Reference |
|---|---|---|---|---|
| AmB; Soy phosphatidylcholine and Tween-80 | Higher AmB penetration in SC and in viable epidermis compared to AmBisome® after topical application in intact human skin. | NA * | NA * | [104] |
| AmB; Soy phosphatidylcholine and sodium cholate | Deeper penetration of AmB and to a larger extent compared to conventional liposomes, after topical application in intact human skin (Franz diffusion cell). | NA * | NA * | [88] |
| AmB; Soy phosphatidylcholine and Tween-80 | Increased drug retention in viable epidermis compared with free AmB, after topical application in intact pig skin (Franz diffusion cell). | NA * | NA * | [105] |
| AmB deoxycholate and meglumine antimoniate (Glucantime®); Span 40; Tween 40; cholesterol; Carbopol® 934 and triethanolamine | NA | BALB/c mice (twice daily for 30 days) | Significant reduction in lesion size after topical treatment with niosomes co-encapsulating AmB and Glucantime® compared to placebo gel (p < 0.001) and intramuscular Glucantime® in L. major-infected mice. Complete lesion healing not observed. | [95] |
| AmB and miltefosine; Phospholipon 90G; Tween-80; Carbopol® 934 and triethanolamine | 6-fold greater AmB permeation of AmB, compared to AmB simple gel applied topically in intact mouse skin (Franz diffusion cell). | BALB/c mice (AmB 1.5 mg/kg/day twice daily for 4 weeks) | Complete lesion resolution with no signs of scaring in L. mexicana-infected mice after topical treatment with co-loaded AmB-miltefosine deformable liposomes. Significant reduction in parasite load at lesion site compared to placebo gel control, AmB gel or single AmB in deformable liposomes. | [96] |
| AmB; sodium deoxycholate; Soy phosphatidylcholine; ethanol and mannitol | Enhanced permeation across intact mouse skin, compared to previously described liposomal formulations. The in vivo skin pharmacokinetic showed permeability and accumulation within the dermis at therapeutic concentrations for CL treatment. | BALB/c mice (0.5 mg/mL, 20 mg of formulation/day, once a day for 10 consecutive days) | Significant reduction in lesion size compared to the control group (untreated) and almost complete reduction in parasite load at lesion site, after topical treatment in L. amazonensis-infected mice. | [97] |
| AmB; Soy phosphatidylcholine; Cholesterol; Dimethyl sulfoxide; Propylene glycol; Oleic acid; Vitamin E; Methylparaben and Propylparaben | Greater amount of permeated AmB through skin from AmB-liposome (0.4%), compared formulation with lower AmB concentration in permeation study after topical application on intact BALB/c mouse skin (Franz diffusion cell). | BALB/c mice (50 mg liposomal AmB 0.4%, twice a day, for four weeks) | Higher efficacy of liposomal AmB formulation (0.4%) after topical treatment in L. major-infected mice, based on the significant reduction (p < 0.001) in lesion size and almost complete elimination of parasite load in skin and spleen compared to control groups (PBS or empty liposomes). | [101,103] |
* NA means not applicable, when no study was performed for the described parameter.