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Biopharmaceutical classification system
1. Submitted to:
Dr. J. Josephine Leno Jenita
Asst. Professor,
Department of Pharmaceutics,
COPS, DSU
Banglore.
Presented by:
Arpitha.B. M
M Pharm (II SEM),
Department of Pharmaceutics,
COPS, DSU
Banglore
BCS CLASSIFICATION SYSTEM
2. CONTENTS
⢠INTRODUCTION
⢠BIOPHARMACEUTICAL CLASSIFICATION SYSTEM [CLASSES]
⢠FACTORS AFFECTING ON BIOPHARMACEUTICAL CLASSIFICATION
SYSTEM
⢠APPLICATION OF BIOPHARMACEUTICAL CLASSIFICATION SYSTEM
⢠REFERENCES
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3. INTRODUCTION
⢠The Biopharmaceutical Classification System was first developed by
in 1995, by Amidon et al & his colleagues.
⢠Definition: âThe Biopharmaceutical Classification System is a
scientific framework for classifying a drug substance based on its
aqueous solubility & intestinal permeability & dissolution rateâ.
⢠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.
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4. ⢠Based on the intestinal permeability and solubility of drugs, Amidon et
al developed Biopharmaceutics Classification System (BCS) which
classifies the drugs into one of the 4 groups as
CLASS SOLUBILITY PERMEABILITY ABSORPTION
PATTERN
RATE LIMITING
STEP IN
ABSORPTION
EXAMPLE
I HIGH HIGH WELL
ABSORBED
GASTRIC
EMPTYING
DILTIAZEM
II LOW HIGH VARIABLE DISSOLUTION NIFEDIPINE
III HIGH LOW VARIABLE PERMEABILITY INSULIN
IV LOW LOW POORLY
ABSORBED
CASE BY CASE TAXOL
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5. ⢠Class I drugs (high solubility/high permeability) are well absorbed
orally since they have neither solubility nor permeability limitation.
⢠Class II drugs (low solubility/high permeability) show variable
absorption owing to solubility limitation.
⢠Class III drugs (high solubility/low permeability) also show variable
absorption owing to permeability limitation.
⢠Class IV drugs (low solubility/low permeability) are poorly absorbed
orally owing to both solubility and permeability limitations.
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6. FACTOR AFFECTING ON BCS
⢠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
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7. SOLUBILITY
⢠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 (
37ËC ).
PERMEABILITY
⢠Permeability of the drug to pass the biological membrane which is the
lipophilic.
⢠Permeability is indirectly 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 in vivo reference dose.
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8. DISSOLUTION
⢠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 [900 ml],
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.
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9. APPLICATION
⢠To predict in vivo performance of drug product using solubility and
permeability measurements.
⢠Aid in earliest stages of drug discovery research.
⢠To use in biowaiver considerations.
⢠For research scientist to decide upon which drug delivery technology
to follow or develop.
⢠Also for the regulation of bioequivalence of the drug product during
scale up and post approval.
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10. REFERENCE
1. Brahmankar D.M., Jaiswal S.B., First edition, âAbsorption of Drugsâ
Biopharmaceutics and Pharmacokinetics â A treatise, Vallabh
Prakashan, Delhi 1995.
2. Shargel L., Andrew B.C., Fourth edition âPhysiologic factors related
to drug absorptionâ Applied Biopharmaceutics and Pharmacokinetics,
Prentice Hall International, INC., Stanford 1999.
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