In terms of AUC24h and Cmin, Galantamine Hydrobromide powder 6 RAZADYNE ER 24 mg extended-release capsules given once daily under fasting conditions are bioequivalent RAZADYNE tablets 12 mg twice daily. As compared to immediate-release tablets, the Cmax and Tmax of the extended-release capsules were lower and occurred later, with Cmax being about 25% lower and median Tmax occurring about 4.5–5.0 hours after dosing. For RAZADYNE ER extended-release capsules, dose-proportionality is observed over the dose range of 8 to 24 mg daily, and a steady state is reached within a week. The pharmacokinetics of RAZADYNE ER extended-release capsules were not affected by era. Drug exposures were approximately 50% higher in CYP2D6 weak metabolizers than in comprehensive metabolizers. You can get other information from this great site.
When RAZADYNE ER extended-release capsules are taken with food, there are no significant pharmacokinetic changes compared to when they are taken fast.
Populations of Interest
According to data from clinical trials, galantamine concentrations in patients with Alzheimer’s disease are 30-40% higher than in healthy young subjects.
Race And Gender
Galantamine clearance is around 20% lower in women than in men (which is explained by lower body weight in women), according to a population pharmacokinetic study (on 539 men and 550 women), and race (n=1029 White, 24 Black, 13 Asian, and 23 other) did not affect galantamine clearance.
Hepatic Impairment is a condition in which the liver is damaged.
The pharmacokinetics of galantamine in subjects with moderate hepatic dysfunction (n=8; Child-Pugh score of 5-6) is close to the pharmacokinetics of galantamine in healthy subjects after a single 4 mg dose of galantamine tablets. Galantamine clearance was reduced by around 25% in patients with mild hepatic disability (n=8; Child-Pugh score of 7-9) compared to galantamine clearance in healthy volunteers. With increasing hepatic dysfunction, galantamine exposure is expected to rise further [see DOSAGE AND ADMINISTRATION and Use in Specific Populations].
In patients with mild and extreme renal Impairment, AUC increased by 37 percent and 67 percent after a single 8 mg dose of galantamine tablets, respectively, relative to average volunteers [see DOSAGE AND ADMINISTRATION and Use In Specific Populations].
Bad Metabolizers CYP2D6
Approximately 7% of the general population has a genetic mutation that causes the CYP2D6 isozyme to be less active. Bad metabolizer is a term used to describe such people. Compared to comprehensive metabolizers, CYP2D6 weak metabolizers had a comparable Cmax and a 35 percent AUC rise of unchanged galantamine after a single oral dose of 4 mg or 8 mg galantamine.
A total of 356 Alzheimer’s disease patients were genotyped for CYP2D6 (n=210 hetero-extensive metabolizers, 126 homo-extensive metabolizers, and 20 weak metabolizers) in two Phase 3 trials. According to a population pharmacokinetics study, bad metabolizers had a 25% lower median clearance relative to comprehensive metabolizers. Patients that have been classified as poor metabolizers do not need dosage adjustments because the drug dose is individually titrated to tolerability. You can get more information from https://www.wisepowder.com/product-details/272786-64-8/.