Industrial Pharmacy , unit-I BCS Classification

BCS Classifications

1. Industrial Pharmacy-I Course Code:BP502T B.Pharm 5th Semester Unit- I BCS Classification BY Rajat Saxena Assistant Professor IFTM University, Moradabad

2. The Biopharmaceutics Classification System (BCS) is a system to differentiate drugs on the basis of their solubility and permeability BCS (Biopharmaceutical Classification System)

3. “The Biopharmaceutical Classification System is a scientific framework for classifying a drug substance based on its aqueous solubility & intestinal permeability & dissolution rate”. To saved time fast screening is required so drug substances are classified on basis of solubility and permeability. This classification is called Biopharmaceutical Classification System.

4. The Biopharmaceutical Classification System has been developed to provide a scientific approach to allow for to prediction in-vivo pharmacokinetics of oral immediate release(IR) drug product by classifying drug compound based on their, 1.SOLUBILITY 2.PERMEABILITY 3.DISSOLUTION FACTOR AFFECTING ON BCS

5. 1. Highly soluble – highest dose strength < 250mlwater over pH 1-8 2. Highly permeable – extent of absorption in human > 90% of administered dose 3. Highly dissolving – > 85% drug 30 min using USP 1 or 2 in < 900 ml of buffer

6. The Maximum Amount of solute dissolved in a given solvent under standard conditions of temperature, pressure and pH. Solubility is the ability of the drug to be solution after dissolution The higher single unit dose is completely soluble in 250 ml at pH 1-6.8 ( 37˚C ). Solubility

7. Permeability of the drug to pass the biological membrane which is the lipophilic . Permeability is in directly based on the extent of absorption of a drug substance. Drug substance is considered to be highly permeable, when the extent of absorption in human determined to be 90% or more of administered drug or compare to invivo reference dose . Permeability

8. It is process in which solid substance solubilises in given solvent i.e mass transfer from solid surface to liquid phase. Using USP apparatus I at 100 rpm or USP apparatus II at 50 rpm . Dissolution Media [900ml], 1.0.1 N HCl or simulated gastric fluid (pH 1.2) without enzyme . 2.pH 4.5 buffer & pH 6.8 buffer . 3.Simulated intestinal fluid without enzyme . Dissolution

9. CLASS SOLUBILITY PERMIABILITY DISSOLUTION EXAPLES CLASS I (5-10%) High High Well dissolved Metoprolol Propranolol CLASS II (60-65%) Low High Variable Nifedipine Naproxen CLASS III (5-10%) High Low Variable Cimitidine Metformin CLASS IV (10-20%) Low Low Poorly dissolved Taxol Clorthiazole

10. Ideal for oral route administration . Drug absorbed rapidly . Drug dissolved rapidly . Rapid therapeutic action . Bioavailability problem not expected for immediate release drug product . e.g . Metoprolol , Propranolol , Diltiazem . Class I

11. Oral route for administration . Drug absorb rapidly . Drug dissolve slowly . Bioavailability is controlled by dosage form and rate of release of the drug substance. e . g. Nifedipine , naproxen . Class II

12. Oral route for administration . Drug absorbance is limited . Drug dissolve rapidly . Bioavailability is incomplete if drug is not release or dissolve in absorption window. e . g. Cimitidine , Metformin,Insulin . Class III

13. Poorly absorbed by orally administration . Both solubility & permeability limitation . Low dissolution rate. Slow or low therapeutic action . An alternate route of administration may be needed . e.g.Taxol , Chlorthiazole , Cefexime Trihydrate . Class IV

14. To predict in vivo performance of drug product using solubility and permeability measurements. Aid in earliest stages of drug development research. Help in deciding drug delivery technology. For use to bio waiver consideration. Application

15. In vitro study In vivo bioequivalence Studies data. Condition 1. Drug-highly sol., highly perm.. 2. Drug-broad therapeutic index 3. An IR product rapidly dissolving 4. Excipients used- FDA approved, in other IR dosage form Regulatory Approval Conti…..

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