Bsc Classification
In the development of pediatric as well as adult products, the Biopharmaceutics Classification System (BCS) represents a convenient way to look at solubility and permeability characteristics of drug substances. Free windows 10 password unlocker. Biopharmaceutics Classification System (BCS) is a regulatory mechanism through which drug developers and generic companies can obtain a waiver of clinical bioequivalence studies, also called a. The Biopharmaceutics Classification System (BCS) is a scientific approach designed to predict drug absorption based on the aqueous solubility and intestinal absorptive characteristics of the drug substance.
Slide 3: The biopharmaceutical classification system was developed primarily in the context of immediate release (IR) solid oral dosage forms. It is the scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability. The interest in this classification system is largely because of its application in early drug development and then in the management of product change through its life cycle. It was first introduced into regulatory decision-making process in the guidance document on Immediate Release Solid Oral Dosage Forms: Scale Up And Post Approval Changes.
Slide 7: 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 These compounds have a poor bioavailability. Usually they are not well absorbed over the intestinal mucosa and a high variability is expected. CLASS BOUNDARIES: CLASS BOUNDARIES Solubility class boundaries - It is based on the highest dose strength of an immediate release product.
Bcs Classification Database
A drug is considered highly soluble when the highest dose strength is soluble in 250ml or less of aqueous media over the ph range of 1 to 7.5. The volume estimate of 250ml is derived from typical bioequivalence study protocols that prescribe administration of a drug product to fasting human volunteers with a glass of water.
Bcs Drug Classification
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. 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 and intravenous dose. Applications of BCS in oral drug delivery technology: Applications of BCS in oral drug delivery technology The major challenge in development of drug delivery system for class I drugs is to achieve a target release profile associated with a particular pharmcokinetic and/or pharmacodynamic profile. Formulation approaches include both control of release rate and certain physicochemical properties of drugs like pH-solubility profile of drug. The systems that are developed for class II drugs are based on micronisation, lyophilization, addition of surfactants, formulation as emulsions and microemulsions systems, use of complexing agents like cyclodextrins. Slide 24: The number of pH conditions for a solubility determination can be based on the ionization characteristics of the test drug substance.e.g.
Bcs Classification Ppt
When the pKa of the drug is in the range of 3-5, solubility should be determined at pH = p Ka, pH = p Ka +1, pH = pKa-1, and at pH = 1 and 7.5. A minimum of three replicate determinations of solubility in each pH condition is recommended. Standard buffer solutions described in the USP are considered appropriate for use in solubility studies. CLASSIFICATION: CLASSIFICATION Class 1 (High solubility, high permeability): The high permeability/high solubility of such compounds allows high concentrations in the gut to saturate any transporter, both efflux and absorptive. Efflux transporters may have, however measurable effect on the penetration of the compounds through the blood-brain barrier. If the systemic concentration of the compounds is lower, transporters may overcome the effect of the high passive permeability of the compound. These compounds can also be involved in transporter mediated drug-drug interactions.