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

Nacéra, Chaffai and Aya, Afoutni and Abdelghani, Djahoudi and Mohamed, Djebbar (2025) Formulation and stability study of an Ibuprofen oral suspension with a particular granulometry combining sodium CMC and xanthan gum as suspending agents. GSC Biological and Pharmaceutical Sciences, 32 (1). pp. 321-333. ISSN 2581-3250

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.