solubility

shawahna's picture

Very Rapid Dissolution Is Not Needed To Guarantee Bioequivalence for Biopharmaceutics Classification System (BCS) I Drugs

Journal Title, Volume, Page: 
J Pharm Sci. 2010 Feb;99(2):621-5
Year of Publication: 
2010
Authors: 
H. Kortejärvi
Research and Development, Orion Pharma, Espoo, Finland
A. Koski
Research and Development, Orion Pharma, Espoo, Finland
R. Shawahna
Research and Development, Orion Pharma, Espoo, Finland
Current Affiliation: 
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
J. Malkki
Research and Development, Orion Pharma, Espoo, Finland
K. Ojala
Research and Development, Orion Pharma, Espoo, Finland
M. Yliperttula
Research and Development, Orion Pharma, Espoo, Finland
Preferred Abstract (Original): 
Currently, the EMEA, FDA, and WHO as regulatory authorities accept rapidly dissolving (>85% dissolved in 30 min) biopharmaceutics classification system (BCS) I drug products for biowaiver candidates. In the draft EMEA guideline the requirement has been set tighter, that is, the drug product should be very rapidly dissolving (>85% dissolved in 15 min) to be eligible for a biowaiver. Pharmacokinetic modeling of 32 BCS I drugs was performed to demonstrate that very rapid dissolution is not necessary to guarantee bioequivalence for them. Rapid dissolution and similar dissolution profiles are sufficient criteria for all BCS I drugs.
Syndicate content