Ajay Kumar Shukla*, Ram Singh Bishnoi, Suresh Kumar Dev, Manish Kumar, Vikas Fenin
Mohanlal Sukhadia University Udaipur Rajasthan-313001 India
*Address for Corresponding Author
Ajay Kumar Shukla
Mohanlal Sukhadia University Udaipur-313001, Rajasthan India
The Biopharmaceutical Classification System (BCS) has been a predictive tool for assess the prospective effects of formulation on the human, drug oral bioavailability. When used in combination with in vitro dissolution tests, the BCS can maintain the prediction of in vivo product performance and the development. The biopharmaceutical classification system (BCS) is a new perception in the field of pharmaceutical science. This is a helpful tool for the formulation scientists, for the selection and design of the formulation of any drug molecules. The current developments have also enabled us to predict the solubility and permeability character of the drug molecule in the early development stages so that the necessary structural changes can be made to the molecule in order to optimize the pharmacokinetic parameters. The BCS has also got a place in a variety of guidance documents of regulatory importance. The article sheds light on the possible new criteria and class limits proposed for additional biowaivers based on the underlying physiology of the gastrointestinal tract in mandatory cases. The prospective applications of BCS in drug discovery, drug delivery and drug research as well as extension for BCS are discussed including the development of new drugs and oral controlled release products.
Keywords: Biopharmaceutical classification system, drug delivery, biowaivers