It is not unusual that polymorphism issues have delayed either toxicological or clinical programs throughout the industry. These oral absorption screening tests are often referred as pharmaceutical profiling which data can be used for preliminary BCS classification. A multitude of automated 96 well systems to screen solubility, permeability and metabolism are commercially available. Consequently the determination of solubility, permeability, and metabolic stability have been fully integrated by most pharmaceutical companies as an integral part of high throughput screening (HTS) and lead optimization. The evaluation of oral absorption is critical to the discovery of orally potent compounds.
Wu and L Z Benet completes the absorption process by including the fourth rate-limiting step of first pass metabolism. The Biopharmaceutical Drug Disposition Classification System (BDDCS) proposed by Y. In general, the four necessary steps for a drug to be absorbed are 1) release of drug from dosage forms, 2) maintenance of dissolved state throughout gastrointestinal (GI) track, 3) permeation of drug molecules through GI membrane into hepatic circulation, 4) enterohepatic metabolism that influences the systemic availability. It is because BCS is based on a scientific framework to classify drugs using solubility and permeability as the rate limiting steps in oral absorption. The Biopharmaceutics Classification System (BCS) is not only a useful tool for obtaining waivers for in-vivo bioequivalence studies but also for decision making in the discovery and early development of new drugs.
The opinions expressed in this publication do not necessarily reflect the on-going evolving philosophy of the research organizations represented.
0 kommentar(er)
