Background: In all drug development phases, measures of safety and efficacy parameters are crucial. Asthma, a global public health issue, seriously affects the life quality of children. Theophylline, a phosphodiesterase inhibitor, is a drug that has been employed in treating respiratory diseases. In fact, pediatric formulation of theophylline for this purpose do not exist. Objective. Development and evaluate pharmacologically a new oral formulation of theophylline, and the protective effects by biomarkers of oxidative stress using ovalbumin sensitized Balb/c mice. The new oral theophylline solution not only met the parameters of exact dose, rheology, compatibility, viscosity, pH, taste and stability; but also fulfills the specifications of the pharmacokinetic parameters validated by HPLC-UV and Mass Spectroscopy. Results. In vivo the results showed that theophylline significantly inhibited OVA-induced mucus production and inflammatory response, and considerably impaired OVA-induced generation of reactive oxygen species. Discussion. The results suggest that theophylline formulation relieves asthmatic airway inflammation. Besides, histological changes revealed lesions of lung cells in experimental animals treated with ovalbumin. We believe that this involves oxidative stress-responsive lipid peroxidation pathway; thus, highlighting its potential as a useful therapeutic agent in the management asthmatic children.
García et al. (Thu,) studied this question.