Formulation and study of rectal ibuprofen mucoadhesive hydrogels

Abstract

HYDROGELS Abstract): The rectal route represents an alternative to oral administration in pediat-rics. Ibuprofen is a non- steroidal anti-inflammatory agent, used in all age groups to reduce pain, fever, and inflammation. Aim: to develop and characterize ibuprofen-containing mucoadhesive rectal gels. Material and methods: Carbopol 940, sodium alginate, and low viscosity hydroxypropyl methylcellulose HPMC were used as gel-forming agents and propyl-ene-glycol and glycerin as permeation enhancers. 5% of ibuprofen was incorporated in all formulations. Three gels have been prepared containing 1% Carbopol, 0.5% Carbopol and 5% HPMC, and 5% sodium alginate. The influence of formulation variables on the pharma-co-technical parameters (adhesivity, pH, and diffusion) was studied. The amount of API released through the membrane using a Franz cell in the acceptor media was measured. Mathematical models were applied to model the release of the active substance. Results: The pH of gels ranged between 4.2-5.0. Viscosity varied between 165 and 212 mPas. The detachment force was from 0.02 to 0.12 N. All three gels were formulated suitable for children and adults. Conclusions: The obtained experimental results showed a superior release of ibuprofen from the 5% sodium alginate gel.