Studies On Preparation And Quality Standard Of Oxybutynin Hydrochloride Patch

Overactive bladder is characterized by urinary frequency, urgency and incontinence ofurine. It`s a kind of bladder dysfunction syndrome. Studies have documented a33-61%prevalence in the elderly over the age of65years. It can cause severe social, psychological,hygienic problems. It significantly interfere with patients work and daily routine anddiminished their self-esteem and quality of life.Oxybutynin is used for the treatment of overactive bladder, for it can relax the muscle inthe bladder. It is recommended by the3rd International Consultation on Incontinence, and itis rated A grade. It is already available in tablet/capsule, controlled-release tablet/capsule orsyrup form in the clinical practice. It has an anticholinergic action, and shows more affinityfor M1and M3muscarinic receptors. In addition, it can relax muscle and has a localanaesthetic effect. When using its oral preparations, it will be metabolized toN-desethyloxybutynin which will cause more severe dry mouth, and will inhibit Mreceptors in salivary glands. These make its oral preparations has a high prevalence of drymouth and make patients give up them, althoμgh they can improve patients life quality.Transdermal system is a kind of formulation of which drμgs are slowly absorbed by skin. Itcan avoid direct contact with salivary glands and decrease the concentration ofN-desethyloxybutynin in plasma. And transdermal system can be easily used for elderly.The Clinical studies have proved that Oxybutynin patch is superior to its oral preparationsand preferred for patients.Oxybutynin hydrochloride can be released easily in the gel patch a nd it has successfullybe made into gel in USA, therefore it is suitable for making gel path. In the prescription andprocess research, the appearance, adhesive force, the accumulation penetration amount andlag time are main evaluation factor. Screen the formula of path matrix by orthogonal design.It sμggests that sodium polyacrylate: carbomer: hydroxypropyl methylcellulose:glycerol=0.4:0.2:0.15:2is the best ratio. Choose the transdermal enhancers by Franz-type diffusion cells and SD mouse skin as transdermal barrier. The path has the bestaccumulation penetration amount and the shortest lag time using6%azone,6%oleummenthae and1.2ml propylene glycol.According to the requirement of preparation in ChP, the properties of patch have beenstudied. It is proved that the Oxybutynin hydrochloride has a good quality.