Ropinirole in the Treatment of Restless Legs Syndrome

2009 ◽  
Vol 1 ◽  
pp. CMT.S2053
Author(s):  
Roberto Vetrugno ◽  
Pasquale Montagna

Restless Legs Syndrome (RLS) is a neurological disorder characterized by unpleasant sensations in the legs and an irresistible urge to move them to relieve discomfort. Evidence-based guidelines consider dopaminergic therapy to be the mainstay of treatment for RLS. Ropinirole is a modern, non-ergoline dopamine agonist which has been widely studied for the treatment of moderate-to-severe primary RLS. Data from placebo-controlled studies show that ropinirole significantly improves the symptoms of RLS. These improvements are supported by data from individual studies and pooled analyses. In addition, ropinirole significantly enhances the objective measures of RLS motor symptoms, such as periodic leg movements, and subjective measures of sleep. Ropinirole is generally well-tolerated, but a newly developed extended-release formulation may benefit patients who warrant an extended duration of therapy.

Author(s):  
Yuan-Lin Guo ◽  
Wei Zhang ◽  
Qian Dong ◽  
Geng Liu ◽  
Cheng-Gang Zhu ◽  
...  

2009 ◽  
Vol 59 (1) ◽  
pp. 15-30 ◽  
Author(s):  
Pramod Kumar ◽  
Sanjay Singh ◽  
Brahmeshwar Mishra

Development and biopharmaceutical evaluation of extended release formulation of tramadol hydrochloride based on osmotic technologyExtended release formulation of tramadol hydrochloride (TRH) based on osmotic technology was developed and evaluated. Target release profile was selected and different variables were optimized to achieve it. Formulation variables such as the level of swellable polymer, plasticizer and the coat thickness of semipermeable membrane (SPM) were found to markedly affect drug release. TRH release was directly proportional to the levels of plasticizer but inversely proportional to the levels of swellable polymer and coat thickness of SPM. Drug release from developed formulations was independent of pH and agitation intensity but dependent on osmotic pressure of the release media.In vivostudy was also performed on six healthy human volunteers and various pharmacokinetic parameters (cmax,tmax,AUC0-24,MRT) and relative bioavailability were calculated. Thein vitroandin vivoresults were compared with the performance of two commercial TRH tablets. The developed formulation provided more prolonged and controlled TRH release compared to the marketed formulation.In vitro-in vivocorrelation (IVIVC) was analyzed according to the Wagner-Nelson method. The optimized formulation (batch IVB) exhibited good IVIV correlation (R= 0.9750). The manufacturing procedure was found to be reproducible and formulations were stable over 6 months of accelerated stability testing.


Sign in / Sign up

Export Citation Format

Share Document