[Serial] Front line of DDS development in pharmaceutical industries
Optimization of dosing regimen for MIRCERA® (Epoetin beta pegol) based on pharmacokinetic properties
2015 Volume 30 Issue 2 Pages 139-144
Details
2015 Volume 30 Issue 2 Pages 139-144
Epoetin beta pegol (MIRCERA®) is an erythropoiesis stimulating agent created by integrating a 30kDa methoxy polyethylene glycol (PEG) polymer chain into the erythropoietin (EPO) molecule.Half-life of MIRCERA® in blood was 168-217 hours (mean) in clinical pharmacology study for Japanese hemodialysis patients. This result showed that MIRCERA® was maintained in blood for longer time than the existing recombinant human erythropoietin (rHuEPO) agents (7.5 hours for half-life of epoetin alpha, 9.99 hours for half-life of epoetin beta) and darbepoetin alpha(half-life: 34.54 hours). Based on this pharmacokinetic property, MIRCERA® was thought to be able to treat renal anemia by longer dosage interval than the existing rHuEPO agnets. Both half-lives of MIRCERA® in blood after intravenous and subcutaneous administration were approximately 200 hours which were similar between routes of administration, the drug concentration-time profiles in terminal phase were similar between routes of administration too. Based on this similar sustainability in blood between routes of administration, the unity regimen between intravenous and subcutaneous administration which was impossible for the existing rHuEPO agents was thought be able to be set. To confirm the longer dosage interval and the unity regimen between routes of administration, Phase II and III clinical studies for Japanese chronic kidney disease patients were conducted. The results of these clinical studies showed that MIRCERA® was able to treat renal anemia by longer dosage interval which was two weeks for correction period and four weeks for maintenance period. The results also showed that MIRCERA® was able to treat renal anemia by the unity regimen for intravenous and subcutaneous administration routes. Overall, the launch of MIRCERA® which takes advantage of the technology of drug delivery system in integrating PEG to EPO makes it possible to treat renal anemia by the longer dosage interval and the unity regimen between routes of administration, these features contribute to the convenience and the reduction of incidence for both patients and healthcare professionals.
