TY - JOUR
T1 - Metodo per ottenere una soluzione sterile multidose di oxibutinina per il trattamento della vescica neurologica pediatrica
AU - Zanon, Davide
AU - Maestro, Alessandra
AU - Maximova, Natalia
AU - Pavan, Michela
AU - Loiacono, Stefano
AU - Provasi, Riccardo
AU - Zenoni, Davide
AU - Rovere, Francesca
AU - Moneghini, Mariarosa
PY - 2015/10/1
Y1 - 2015/10/1
N2 - 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.
AB - 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.
KW - Derivative-spectrophotometry
KW - Nuclear Magnetic Resonance (NMR)
KW - Oxybutynin
KW - UV-spectrophotometry
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U2 - 10.1721/2116.22942
DO - 10.1721/2116.22942
M3 - Articolo
AN - SCOPUS:84959374523
VL - 29
SP - 244
EP - 250
JO - Giornale Italiano di Farmacia Clinica
JF - Giornale Italiano di Farmacia Clinica
SN - 1120-3749
IS - 4
ER -