Matches in DBpedia 2014 for { <http://dbpedia.org/resource/Biopharmaceutics_Classification_System> ?p ?o. }
Showing items 1 to 20 of
20
with 100 items per page.
- Biopharmaceutics_Classification_System abstract "The Biopharmaceutics Classification System is a system to differentiate the drugs on the basis of their solubility and permeability. It is a guide for predicting the intestinal drug absorption provided by the U.S. Food and Drug Administration[1]. The fundamental basis for the BCS was established by Gordon Amidon, who was presented with a Distinguished Science Award at the August 2006 International Pharmaceutical Federation (FIP) congress in Salvador, Brazil.[citation needed]This system restricts the prediction using the parameters solubility and intestinal permeability. The solubility classification is based on a United States Pharmacopoeia (USP) aperture. The intestinal permeability classification is based on a comparison to the intravenous injection. All those factors are highly important because 85% of the most sold drugs in the United States and Europe are orally administered.According to the Biopharmaceutics Classification System, drug substances are classified as follows:Class I - high permeability, high solubility Example: metoprolol Those compounds are well absorbed and their absorption rate is usually higher than excretion.Class II - high permeability, low solubility Example: glibenclamide, bicalutamide, ezetimibe The bioavailability of those products is limited by their solvation rate. A correlation between the in vivo bioavailability and the in vitro solvation can be found.Class III - low permeability, high solubility Example: cimetidine The absorption is limited by the permeation rate but the drug is solvated very fast. If the formulation does not change the permeability or gastro-intestinal duration time, then class I criteria can be applied.Class IV - low permeability, low solubility Example: hydrochlorothiazide Those compounds have a poor bioavailability. Usually they are not well absorbed over the intestinal mucosa and a high variability is expected.The drugs are classified in BCS on the basis of following parameters:1. Solubility2. Permeability3. DissolutionThe class boundaries for these parameters are:1. Solubility class boundaries- It is based on the highest dose strength of an immediate release product. A drug is considered highly soluble when the highest dose strength is soluble in 250 ml or less of aqueous media over the pH range of 1 to 7.5. The volume estimate of 250 ml is derived from typical bioequivalence study protocols that prescribe administration of a drug product to fasting human volunteers with a glass of water.2. Permeability class boundaries- It is based indirectly on the extent of absorption of a drug substance in humans and directly on the measurement of rates of mass transfer across human intestinal membrane. Alternatively non-human systems capable of predicting drug absorption in humans can be used (such as in-vitro culture methods). A drug substance is considered highly permeable when the extent of absorption in humans is determined to be 90% or more of the administered dose based on a mass-balance determination or in comparison to an intravenous dose.3. Dissolution class boundaries- An immediate release product is considered rapidly dissolving when no less than 85% of the labeled amount of the drug substance dissolves within 15 minutes using USP Dissolution Apparatus 1 at 100 RPM or Apparatus 2 at 50 RPM in a volume of 900 ml or less in the following media: 0.1 N HCl or simulated gastric fluid or pH 4.5 buffer and pH 6.8 buffer or simulated intestinal fluid.".
- Biopharmaceutics_Classification_System wikiPageExternalLink www.fda.gov.
- Biopharmaceutics_Classification_System wikiPageExternalLink ucm128219.htm.
- Biopharmaceutics_Classification_System wikiPageID "4248332".
- Biopharmaceutics_Classification_System wikiPageRevisionID "590767542".
- Biopharmaceutics_Classification_System hasPhotoCollection Biopharmaceutics_Classification_System.
- Biopharmaceutics_Classification_System subject Category:Pharmacology.
- Biopharmaceutics_Classification_System subject Category:Pharmacy_in_the_United_States.
- Biopharmaceutics_Classification_System comment "The Biopharmaceutics Classification System is a system to differentiate the drugs on the basis of their solubility and permeability. It is a guide for predicting the intestinal drug absorption provided by the U.S. Food and Drug Administration[1].".
- Biopharmaceutics_Classification_System label "Biopharmaceutics Classification System".
- Biopharmaceutics_Classification_System label "Biopharmazeutisches Klassifizierungssystem".
- Biopharmaceutics_Classification_System label "System klasyfikacji biofarmaceutycznej".
- Biopharmaceutics_Classification_System label "نظام تصنيف الصيدلانيات البيولوجية".
- Biopharmaceutics_Classification_System sameAs Biopharmazeutisches_Klassifizierungssystem.
- Biopharmaceutics_Classification_System sameAs System_klasyfikacji_biofarmaceutycznej.
- Biopharmaceutics_Classification_System sameAs m.0bs7d6.
- Biopharmaceutics_Classification_System sameAs Q278760.
- Biopharmaceutics_Classification_System sameAs Q278760.
- Biopharmaceutics_Classification_System wasDerivedFrom Biopharmaceutics_Classification_System?oldid=590767542.
- Biopharmaceutics_Classification_System isPrimaryTopicOf Biopharmaceutics_Classification_System.