Bcs Classification System
Biopharmaceutics Classification System. Biopharmaceutics Classification System (BCS) has provided a mechanistic framework for understanding the concept of drug absorption in terms of permeability and solubility. This article reviews the criteria and issues for classifying drugs according to the BCS. The Biopharmaceutical Classification System (BCS) is an experimental model that measures permeability and solubility under prescribed conditions. The original purpose of the system was to aid in the regulation of post-approval changes and generics, providing approvals based solely on in vitro data when appropriate.
Applying for a BCS-based biowaiver is restricted to highly soluble drug substances with known human absorption and considered not to have a narrow therapeutic index. The concept is applicable to immediate release, solid pharmaceutical products for oral administration and systemic action having the same pharmaceutical form. However, it is not applicable for sublingual, buccal, and modified release formulations.
Bcs Classification System
For orodispersible formulations the BCS-based biowaiver approach may only be applicable when absorption in the oral cavity can be excluded. Biowaiver may be applicable when the active substance(s) in test and reference products are identical.
Biowaiver may also be applicable if test and reference contain different salts provided that both belong to BCS-class I. Biowaiver is not applicable when the test product contains a different ester, ether, isomer, mixture of isomers, complex or derivative of an active substance from that of the reference product, since these differences may lead to different bioavailabilities not deducible by means of experiments used in the BCS-based biowaiver concept. Investigations related to the medicinal product should ensure immediate release properties and prove between the investigative products, i.e. Test and reference show similar in vitro dissolution under physiologically relevant experimental pH conditions. However, this does not establish an in vitro/in vivo correlation. In vitro dissolution should be investigated within the range of pH 1 – 6.8 (at least pH 1.2, 4.5, and 6.8).
Set the Unknown Sources permission to ‘enable’. This is necessary to install any app outside of the Google Play Store. Ios keyboard for android apk.
Bcs Biopharmaceutical Classification System
Additional investigations may be required at pH values in which the drug substance has minimum solubility. The use of any surfactant is not acceptable.