Very rapid dissolution is not needed to guarantee bioequivalence for biopharmaceutics classification system (BCS) I drugs.
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.
Research and Development, Orion Pharma, Espoo, Finland.
H
H
Kortejärvi
R
R
Shawahna
A
A
Koski
J
J
Malkki
K
K
Ojala
M
M
Yliperttula
D000042:Absorption; D000465:Algorithms; D001702:Biopharmaceutics / Q000145:classification*; D003198:Computer Simulation; D006207:Half-Life; D008956:Models, Chemical; D004364:Pharmaceutical Preparations / Q000145:classification*; D019999:Pharmaceutical Solutions; D010599:Pharmacokinetics; D012995:Solubility
D004364:Pharmaceutical Preparations; D019999:Pharmaceutical Solutions