Abstract
BACKGROUND: Oral ivermectin can be used to treat scabies. Evidence for safe and effective use in young children in individual treatment situations has been developed and published. In order to also ensure a body weight-adapted dosage for children, an ivermectin-containing syrup was developed as an extemporaneous preparation. MATERIALS AND METHODS: Since ivermectin is not available as a pure substance for the formulation, tablets containing active ingredient were used as a basic material for development. The formulation was designed according to pharmaceutical, regulatory and use-oriented criteria. An HPLC (high-pressure liquid chromatography) method was developed and validated to demonstrate chemical stability. In order to facilitate the practical implementation, information on suitable packaging material and application aids was also developed and the formulation was evaluated. RESULTS: It has been demonstrated that the final formulation produced in the pharmacy was stable and can be stored for 3 weeks. No concerns were raised regarding the tolerability of the syrup formulation. The physicochemical properties and the taste of the formulation allow the intended use as a well-dosed syrup for children. CONCLUSION: The developed formulation meets the requirements of the Apothekenbetriebsordnung (Pharmacy Work Rules; Section 7 ApBetrO) and enables an exact, body weight-adapted dosage of oral ivermectin in young children. Studies on human pharmacokinetics or clinical studies to demonstrate tolerability and/or efficacy are not available for the formulation.