Bcs Class 1 Drugs
Bcs classification system • 1. Meas soksophea old song. Best apk apps. BIOPHARMACEUTICS CLASSIFICATION SYSTEM • Contents• Introduction• Overview of the Classification system• Applications• Conclusion• References • Introduction ۞Biopharmaceutics Classification System (BCS)♥ Scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability What is the need for a classification based on biopharmaceutics of the drug?
Bcs Class 1 Drugs
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Its importance in determining bioavailability • ORAL ROUTE♠ Route of choice for the formulators Continues to dominate the area of drug delivery technologies. LIMITATIONS Absorption and Bioavailability in the milieu of gastrointestinal tract. Limitations more prominent with the advent of protein and peptide drugs compounds emerging as a result of combinatorial chemistry and the technique of high throughput screening • API structure salt form and excipients Bioavailability of drug is determined byextent of drug solubility and permeability drug solubility drug product quality attributes • Biopharmaceutics Classification System Guidance provided by the U.S. Food and Drug Administration for predicting the intestinal drug absorption The fundamental basis established by Dr. Gordon Amidon Distinguished Science Award (Aug ’06,FIP) First introduced into regulatory decision-making process in the guidance document on Immediate Release Solid Oral Dosage Forms: Scale Up And Post Approval Changes • Drug development tool that allows estimation of the contributions of 3 major factors, that affect oral drug absorption from immediate release solid oral dosage forms Dissolution Solubility Intestinal permeability.