Development of a dosing device for individualized dosing of orodispersible warfarin films.

Individualized medicine is relevant to ensure safe and efficient pharmacotherapy. It requires a suitable dosage form and a matching dosing device to enable flexible dosing serving the needs of individual dose requirements. For oral films no flexible dosing option is available until today. This study covers the development of a dosing device that enables flexible dosing of films within the pharmacopoeial requirements. The prototype was produced with the 3D-printing technique fused filament fabrication. The developed and produced prototype of the device was tested for the uniformity of doses according to Ph.Eur. 2.9.27 and 2.9.40. A ribbon as model film and an oral film with HPMC as polymer matrix met the specifications for both tests for three different lengths dispensed with the prototype of the dosing device (HPMC film: AV = 11.30 (1 cm), 12.04 (2 cm) and 10.19 (5 cm)). A second oral film with a polymer matrix from PVA and HPMC exceeded the threshold for the shortest piece of 1 cm (AV = 26.54) because of slight splintering during the cutting process, likely due to too little plasticizer in the formulation. A successful device development and a use within the specifications of the European Pharmacopoeia is demonstrated.