Developing an Original Formulation and Drug Delivery Framework for Artemisinin-Based Paediatric Products Using Locally Sourced Nigerian Excipients

Artemisinin-based paediatric formulations require age-appropriate delivery systems that overcome poor aqueous solubility, bitter taste, and dose uniformity challenges, yet reliance on imported excipients increases production costs for Nigerian manufacturers. This study developed an original drug delivery framework for artemisinin-based paediatric products utilising locally sourced Nigerian plant-derived excipients as functional pharmaceutical ingredients. A pharmaceutical sciences research methodology encompassing excipient characterisation, formulation development, and evaluation was employed. Locally sourced excipients characterised included locust bean gum (viscosity modifier), tamarind kernel powder (disintegrant), and Butyrospermum parkii (Shea butter) derivatives (lipid excipient). Characterisation covered physicochemical properties, particle size distribution, moisture content, and safety profiles. Artemether and artesunate dispersible tablet and granule formulations were developed using a design of experiments approach. Optimised formulations were evaluated for dissolution performance, dose uniformity, stability under ICH Zone IV conditions, taste masking effectiveness (electronic tongue), and comparative bioavailability in a rat model. Three optimised formulations demonstrated dissolution profiles not inferior to reference WHO prequalified products (f2 above 50). Taste masking scores were acceptable for all lead formulations. Accelerated stability at 40 degrees Celsius and 75 percent RH showed adequate shelf life prediction above 24 months. Relative bioavailability was 94.6 to 101.3 percent compared to reference. The study provides an original contribution to Nigerian pharmaceutical product development science and demonstrates the technical feasibility of locally-sourced excipient-based artemisinin paediatric formulations.

Keywords: drug delivery, artemisinin, paediatric formulation, Nigerian excipients, pharmaceutical development