The aim of the present investigation is to produce rapidly disintegrating laminar extrudates for\ndelivering ibuprofen in the mouth of paediatric patients. This laminar shape is particularly\nconvenient for drug delivering in the mouth and can be easily cut in cut in different sizes allowing\nfor a convenient adjustment of the drug dose depending on the age of the patient. Due to the fact\nthat in paediatric formulations, the selection of the excipients is always a challenging issue and the\nreduction of their amount is always highly desirable, in this study to select the most appropriate\ncomposition to achieve a rapid disintegration and simultaneously permit a high amount of\nibuprofen in the system, an experimental design for mixtures was employed and the disintegration\ntime in simulated saliva was used as experimental response. In addition, after solid state analyses to\ncheck possible insurgence of drug-excipients interactions, laminar extrudates were characterised in\nterms of mechanical properties and in vitro dissolution performances. Extrudates with the desired\nuniform laminar shape, constant thickness (2 mm) and a very high content of drug (82% wt) were\nproduced. These products exhibited a short disintegration time. The dose for a patient of 6-12 years\ncorresponded to a length of extrudate between 1-1.5 cm, perfectly compatible with a formulation\norodispersible thin laminar extrudate intended for a paediatric patient (Figure 1).
Loading....