Formulation and stability study of an Ibuprofen oral suspension with a particular granulometry combining sodium CMC and xanthan gum as suspending agents

Objective: The aim of this study was to formulate a stable pediatric oral suspension of Ibuprofen (IBP) with particular granulometry using Sodium Carboxymethyl Cellulose (Na CMC) combined to Xanthan gum (XG)as suspending agents. Materials and methods: Suspensions were prepared with Na CMC (2%; 2.25%), XG (0.75%; 1%) and the Na CMC-XG combination at the following ratios: 0.75%-0.25%; 1%-0.50%; 0.75%-0.75%. The suspensions developed underwent a stability study for organoleptic and physicochemical characteristics, sedimentation and redispersibility volumes, and biopharmaceutical properties. The microbiological quality of the high-performance suspension was also assessed. Results: The stability study revealed that suspension of IBP, F6, with a predominance of particles in the [100-200 mm] granulometric class (62%), with an average size of 158 mm, prepared with the combination, 1%Na CMC-0.5%XG was demonstrated a stable optimum viscosity, equivalent to 0.8 cPs. F6 with satisfactory organoleptic characteristics (homogeneous, white with vanilla odor and taste, fluid), pH in the range 3.6-4.6, stable (F=1), with satisfactory dissolution kinetics, conforming to standards and with microbiological quality conforming to the acceptance criteria for the microbiological quality of non-sterile pharmaceutical forms was considered as a high-performance suspension. Conclusion: It was concluded that F6 formulation containing Na CMC combined with XG at a concentration of 1%-0.5% appears to be the optimal formulation of a stable oral suspension of IBP with a coarse particle size and could be proposed for the formulation of other drugs with a similar particle size.