| Title | Very rapid dissolution is not needed to guarantee bioequivalence for biopharmaceutics classification system (BCS) I drugs. | | Author(s) | Kortejärvi H, Shawahna R, Koski A, Malkki J, Ojala K, Yliperttula M | | Institution | Research and Development, Orion Pharma, P.O. Box 65, 02101 Espoo, Finland. | | Source | J Pharm Sci 2009 Oct 20. | | Abstract | 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. (c) 2009 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci. | | Language | ENG | | Pub Type(s) | JOURNAL ARTICLE
| | PubMed ID | 19844950 |
|
