Carbidopa-levodopa Extended-release Capsules
【CONTENTS】Carbidopa-levodopa Extended-release Capsules (RYTARY)
【SPECIFICATIONS】carbidopa/ levodopa: 23.75mg/95mg,36.25mg/145mg
【INDICATIONS】
Parkinson's disease.
Post-encephalitic parkinsonism.
Parkinsonism that may follow carbon monoxide intoxication or manganese intoxication
【DOSAGE AND ADMINISTRATION】
The recommended starting dosage of RYTARY in levodopa-naïve patients is 23.75 mg / 95 mg taken orally three times a day for the first 3 days. On the fourth day of treatment, the dosage of RYTARY may be increased to 36.25 mg / 145 mg taken three times a day.
【REGISTRY CLASSIFICATION】Chemical drugs 3.1
【INTRODUCTION】
RYTARY was first developed by IMPAX LABORATORIES INC and was approved by FDA in January, 2015.
Parkinson's disease is a common neurological disease and the incidence of Parkinson's disease is very high in the elderly. According to the world Parkinson's Disease Association statistics, more than 5 million people suffer from Parkinson's disease which is the third major diseases after stroke and epilepsy. The latest national research and analysis of epidemiology show that the probability of having Parkinson's disease is 1% for the elderly in China and the probability is about 1.7% for people over the age of 65. Now more than 2000,000 people suffer from Parkinson's disease in China and the number increases more than 100,000 annually.
Levodopa therapy is the gold standard for the treatment of symptoms of Parkinson's disease. But levodopa has narrow window of GI absorption and short half-life. Existing oral formulations do not provide stable therapeutic levodopa plasma concentration in subjects:
Immediate-release products produce large plasma CMAX/CMIN fluctuations .
Extendsd-release levodopa products are reported to have slow absorption and unpredictable effects in some subjects with motor fluctuations.
Infusion studies demonstrate providing stable plasma levodopa concentrations and avoiding low plasma concentrations are associated with reduced “Off”times and reduced dyskinesia rates. RYTARY is a novel oral carbidopa-levodopa extended-release formulation,designed to rapidly attain and maintain therapeutic levodopa plasma concentrations for a prolonged duration.Several studies in healthy subjects have demonstrated RYTARY maintains stable plasma levodopa concentrations for approximately 6 hours with a low fluctuation index.
In a word, Parkinson's disease treatment drugs have extensive market prospect. Furthermore carbidopa-levodopa extended-release capsules can achieve a better therapeutic effect and reduce adverse reaction based on its unique pharmaceuticals technology. It is belived that RYTARY will have an important place in Parkinson's disease treatment.
【INTELLECTUAL PROPERTY】
There is no risk of infringement.
【TRANSFER TARGETS】
Process of capsules production
Data for declaring
【RESEARCH PROGRESS】
Lab experiment is conducting.
Quality research method is developing.