Study of paracetamol-containing pastilles produced by melt technology

The focus of this work was to apply melt technology for the formulation of a pastille containing paracetamol (PCT) in a solid dispersion with two sugar alcohols (xylitol and mannitol) and polyethylene glycol 6000 (PEG) as the carrier system components. Optimization of the pastillization was performed both statistically by using the Box–Behnken design and experimentally by determining the phase diagrams. For the latter and recrystallization of the components, differential scanning calorimetry detection was utilized. The developed pastilles consisted of a eutectic mixture of xylitol (61.25 %) and mannitol (15.31 %) with PEG (7.81 %) as carrier system together with PCT (15.63 %). The components of the pastilles underwent recrystallization at different rates for 5 days. Transmission Raman spectroscopy revealed the homogeneous distribution of the PCT in the pastille. X-ray powder diffractometry showed that the recrystallization of the PCT resulted in its monoclinic form I, while dispersive Raman spectroscopy detected both the monoclinic and orthorhombic forms. The drop-melted pastilles displayed relatively high hardness, and the PCT dissolved within 15 min. It is concluded that pastillization can be achieved through melt technology and the structure and the technological parameters of the pastille are suitable for the development of lozenges as a solid dosage form for children therapy.