Novel Patient-Friendly Orodispersible Formulation of Ivermectin is Associated With Enhanced Palatability, Controlled...

Area of Science:

• Pharmacology
• Clinical Pharmacy
• Pediatric Medicine

Background:

• Ivermectin is a widely used anthelmintic and antiectoparasite agent.
• Current oral formulations are designed for adults, lacking pediatric-specific options.
• A new orodispersible tablet formulation (CHILD-IVITAB) has been developed for pediatric use.

Purpose of the Study:

• To compare the palatability, tolerability, bioavailability, and pharmacokinetics of CHILD-IVITAB against marketed ivermectin tablets (STROMECTOL).
• To assess the variability of drug exposure between the two formulations in healthy adults.
• To inform the pediatric clinical development program for CHILD-IVITAB.

Main Methods:

• Phase I, single-center, open-label, randomized, 2-period, crossover trial.
• 16 healthy adults received a single 12 mg dose of CHILD-IVITAB or STROMECTOL in a fasting state.
• Evaluated palatability, tolerability, safety, and pharmacokinetic parameters (Cmax, AUC, Tmax).

Main Results:

• CHILD-IVITAB demonstrated significantly enhanced palatability compared to STROMECTOL.
• Both formulations were well-tolerated and safe.
• Relative bioavailability of CHILD-IVITAB was 1.52 (Cmax), 1.27 (AUC0-∞), and 1.29 (AUC0-last).
• Tmax was earlier with CHILD-IVITAB (median 3.0h vs 4.0h).
• Variability in drug exposure was halved with CHILD-IVITAB (37% vs 70% CV).

Conclusions:

• CHILD-IVITAB offers improved palatability and reduced pharmacokinetic variability compared to STROMECTOL.
• The formulation is safe and well-tolerated in adults.
• These findings support further clinical evaluation of CHILD-IVITAB in pediatric populations for parasitic diseases.