Investigation of Optimal Expiration Date and Administration Device for Intravesical Oxybutynin Instillation Solution

Abstract

Oxybutynin hydrochloride (OB) is often used in intravesical instillation therapy for spastic neurogenetic bladder.The purposeof this study was to determine the expiration date and administration device for intravesically administered OB solutionscontaining sodium hyaluronate (HYA) as a pharmaceutical additive to enhance the muco-adhesiveness of the solution.The stability of OB in containers made of glass,polystyrene (PS),polypropylene (PP) and polyethylene (PE) was investigatedunder various temperature and light exposure conditions.Sorption of OB was observed in PP and PE containers andfor the latter,it was enhanced at higher temperatures and pHs.Based on these results,the optimal expiration date and storageconditions of OB solution were determined to be 84 days in a cool place (4°C),in a PP container.