Formulation and Evaluation of Ibuprofen Oral ...

Formulation and Evaluation of Ibuprofen Oral Suspension

Author Name : Mrs. Karthika Gouthaman , Ms. Rini Punathil , Ms. Meeti Mahaur

ABSTRACT The present investigation relates to the development of an oral suspension containing Ibuprofen that would be bioequivalent to the competitor product – Brufen Paediatric Syrup (Abott Laboratories). To evaluate the dissolution performance of the suspension (in vitro) The drug release pattern of the trial batches and the competitor would be studied comparatively at both 50 and 25 RPM. The trial batch that matches the competitor at both the levels would be selected for ʽin vivo’ bioequivalence studies. This in vitro dissolution profile matching at two different levels of paddle RPM would serve as a proof to ensure similar performance of the product in vivo irrespective of variation in gastric intestinal motility among the patients/subjects. The optimum formulation was then selected and the results showed that physically stable and optimum drug release profile could be obtained when agar and Avicel RC 591 were added at 0.05 and 1.5% respectively. The formulation F-16 were selected and evaluated for physical parameters, assay and accelerated stability studies as per ICH guidelines. The results showed that there were no significant changes in the selected formulations. The outcome of the experimental work indicates that the prepared suspension has the potential for further studies.