CHILD-IVITAB, a Novel Orodispersible Ivermectin Formulation-Pharmaceutical Evaluation and Clinical Acceptability in Children <15 kg.

Background/Objectives: Scabies is a disease that disproportionately affects young children. Oral ivermectin is a mainstay of scabies therapy, yet children <15 kg are excluded due to insufficient safety data and the lack of age-appropriate formulations. To address this gap, we developed CHILD-IVITAB, a 1 mg ivermectin orodispersible tablet based on the Template Inverted Particle technology, which enables rapid disintegration and intrinsic taste masking in a mechanically robust tablet. Methods: We report the pharmaceutical characterization of CHILD-IVITAB tablets. The EPIC-15 trial (NCT06404333) was a randomized clinical trial administering CHILD-IVITAB to children weighing 5 to <15 kg with uncomplicated scabies in Brazil. Acceptability was assessed at two administrations (D0, D7) using the ClinSearch Acceptability Score Test (CAST®), wherein CHILD-IVITAB was compared to a reference dataset. Results: The 40 mg tablets had a tensile strength of 1.87 ± 0.16 MPa, and met Ph. Eur. requirements for uniformity of mass and dosage units. CHILD-IVITAB tablets disintegrated in vitro in 18.3 ± 1.1 s and released >50% of the dose within 1 min in artificial saliva. Thirteen children were enrolled in the trial. The full dose was taken in 100% of the 26 evaluations, 73% of administrations elicited a neutral or positive reaction, and no dosage form alteration, food/drink co-administration, or extra device was required. The barycenter of all evaluations fell within the positive zone of the CAST® framework. Conclusions: These results support CHILD-IVITAB as a child-friendly ivermectin formulation suitable for children 5 to <15 kg, a population currently excluded from ivermectin treatment and prevention programs.