Determination of propiverine hydrochloride in human plasma by high performance liquid chromatographytandem mass spectrometry: application to the pharmacokinetic study of a sustained release formulation

Huang, Meihua; Tian, Ye; Zhang, Zunjian; Zhang, Hongwen; Lin, Hui

doi:10.1055/s-0031-1296223

Arzneimittelforschung

2011

DOI: 10.1055/s-0031-1296223

|View full text |Cite

Determination of propiverine hydrochloride in human plasma by high performance liquid chromatographytandem mass spectrometry: application to the pharmacokinetic study of a sustained release formulation

Meihua Huang

Ye Tian

Zunjian Zhang

et al.

Abstract: A rapid, sensitive and reliable high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method was developed and validated for the determination of propiverine hydrochloride (CAS 54556-98-8) in human plasma using cetirizine di-hydrochloride as internal standard (IS, CAS 8388-51-0). Following liquid-liquid extraction with ethyl acetate, the separation was performed on a reverse phase C18 column with a mobile phase consisted of metha-nol-ammonium acetate (pH 4.0; 10 mM) (70:30, v/v). The det… Show more

Help me understand this report

Search citation statements

Order By: Relevance

Paper Sections

Select...

Citation Types

Supporting

Mentioning

Contrasting

Year Published

2013

2016

Publication Types

Select...

Article2

Relationship

Self Cite0

Independent2

Authors

Journals

Cited by 2 publications

References 6 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

Propiverine

McKeage

2013

Clinical Drug Investigation

View full text Add to dashboard Cite

Propiverine is a well established antimuscarinic agent with a mixed mode of action in the treatment of symptoms associated with overactive bladder (OAB). As well as blocking muscarinic receptors in the detrusor muscle, the drug also inhibits cellular calcium influx, thereby diminishing muscle spasm. In patients with symptoms of OAB resulting from idiopathic detrusor overactivity (IDO) or neurogenic detrusor overactivity (NDO), propiverine demonstrated dose-dependent efficacy and tolerability, with adverse events consistent with those associated with all antimuscarinic agents. In adults with IDO, propiverine demonstrated similar efficacy to that of other antimuscarinic agents (including solifenacin, tolterodine, oxybutynin and imidafenacin) and, in adults with NDO, propiverine and oxybutynin demonstrated similar efficacy. Propiverine was generally well tolerated in these patient populations, with a lower incidence of dry mouth than that associated with oxybutynin. In men with lower urinary tract symptoms (LUTS), and in whom the presence of benign prostatic enlargement (BPE) was implicated, propiverine administered as add-on therapy to an α(1)-adrenoceptor antagonist demonstrated similar or superior efficacy to that achieved with an α(1)-adrenoceptor antagonist alone, and combination therapy was particularly effective in patients with urinary storage symptoms. Combination therapy was generally well tolerated, but was associated with a higher incidence of adverse events than an α(1)-adrenoceptor antagonist alone. In children and adolescents with IDO/OAB or NDO, propiverine was generally more effective and better tolerated than oxybutynin. In conclusion, propiverine provides a valuable option for the treatment of adults and children with OAB associated with IDO or NDO, and in men with storage LUTS.

show abstract

Propiverine

McKeage

2013

Clinical Drug Investigation

View full text Add to dashboard Cite

show abstract

Results of a randomized, double‐blind, active‐controlled clinical trial with propiverine extended release 30 mg in patients with overactive bladder

et al. 2016

View full text Add to dashboard Cite

ObjectiveTo compare the efficacy and safety of the 30 mg extended release (ER) formulation of propiverine hydrochloride with the 4 mg ER formulation of tolterodine tartrate in patients with overactive bladder (OAB) in a non-inferiority trial. Patients and MethodsEligible patients, aged 18-75 years and with symptoms of OAB, were enrolled in this multicentre, randomized, doubleblind, parallel-group, active-controlled study. After a 2-week screening period, patients were randomized at a 1:1 ratio to receive either propiverine ER 30 mg or tolterodine ER 4 mg daily during the 8-week treatment period. Efficacy was assessed using a 3-day voiding diary and patient's selfreported assessment of treatment effect. Safety assessment included recording of adverse events, laboratory test results, measurement of post-void residual urine and electrocardiograms. ResultsA total of 324 patients (244 female and 80 male) were included in the study. Both active treatments improved the variables included in the voiding diary and in the patient's self-reported assessment. The change from baseline in the number of voidings per 24 h was significantly greater in the propiverine ER 30 mg group compared with the tolterodine ER 4 mg group after 8 weeks of treatment (full analysis set [FAS] À4.6 AE 4.1 vs À3.8 AE 5.1; P = 0.005). Significant improvements were also observed for the change of urgency incontinence episodes after 2 weeks (P = 0.026) and 8 weeks (P = 0.028) of treatment when comparing propiverine ER 30 mg with tolterodine ER 4 mg. Both treatments were well tolerated, with a similar frequency of adverse drug reactions in both the propiverine ER 30 mg and tolterodine ER 4 mg groups (FAS 40.7 vs 39.5%; P = 0.8). More patients treated with tolterodine ER 4 mg discontinued the treatment because of adverse drug reactions compared with propiverine ER 30 mg (7.4 vs 3.1%). ConclusionsPropiverine ER 30 mg was confirmed to be an effective and well-tolerated treatment option for patients with OAB symptoms. This first head-to-head study showed noninferiority of propiverine ER 30 mg compared with tolterodine ER 4 mg.

show abstract

scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.

Contact Info

customersupport@researchsolutions.com

10624 S. Eastern Ave., Ste. A-614

Henderson, NV 89052, USA

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Blog Terms and Conditions API Terms Privacy Policy Contact Cookie Preferences Do Not Sell or Share My Personal Information

Made with 💙 for researchers

Part of the Research Solutions Family.

Determination of propiverine hydrochloride in human plasma by high performance liquid chromatographytandem mass spectrometry: application to the pharmacokinetic study of a sustained release formulation

Cited by 2 publications

References 6 publications

Propiverine

Propiverine

Results of a randomized, double‐blind, active‐controlled clinical trial with propiverine extended release 30 mg in patients with overactive bladder

Contact Info

Product

Resources

About