A method to obtain and guarantee a multidose sterile oxybutynin solution useful in treating pediatric neurogenic bladder

Summary. A method to obtain and guarantee a multidose sterile oxybutynin solution useful in treating pediatric neurogenic bladder. Objective. Oxybutynin hydrochloride represents one of the anticholinergic drugs used in pediatric neurogenic bladder, and it is available either orally in generic formulation as tablets and syrup, or as a transdermal patch and as a topical gel. Despite the efficacy of oxybutynin, these systemic delivery systems present significant side effects, and therefore a number of studies have explored an intravesical oxybutynin solution as an alternative. Since a commercial intravesical oxybutynin solution for use in pediatric neurogenic bladder is currently not available, it could be useful to find a method to guarantee the sterility of prepared oxybutynin solution in order to prevent bacterial growth in the urinary tract after catheterization. Methods. A simple method to prepare a stable and sterile multidose solution of oxybutynin for pediatric neurogenic bladder was developed. The stability of the solution was evaluated using two techniques: ultraviolet (UV) spectrophotometry and spectrometric Nuclear Magnetic Resonance (NMR)”. In order to maximize the sensitivity of both the proposed methods solvent system, wavelength of detection, and mass spectrometry conditions were optimized. Results. No spectrum changes have been observed with UV/Vis method and no quantitative modification has been noticed in the NMR method. The solution after six months conforms perfectly with that calculated on the same solution when initially prepared. Conclusions. It was concluded that both methods that were developed are equally accurate, sensitive, precise, reproducible, and efficient, and both could be applied directly and easily to evaluate the pharmaceutical preparation of oxybutynin. The stability and sterility of the oxybutynin solution were determined to last six months.