Which four points are taken into consideration in classifying the drugs? Explain in detail.
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BCS) is a scientific
framework for classifying drug substances based on their aqueous
solubility and intestinal permeability. This classification system
was devised by Amidon et al.
[1] This concept underlying the BCS
published finally led to introducing the possibility of waiving in vivo
bioequivalence (BE) studies in favor of specific comparative in vitro
testing to conclude BE of oral immediate release (IR) products with
systemic actions. The BCS has found international recognition
in industry, academic institutions and public authorities.[2] The
principle of the BCS is that if two drug products yield the same
concentration profile along the gastrointestinal (GI) tract, they will
result in the same plasma profile after oral administration. This
concept can be summarized by the following equation:[3]
J 5 PwCw (1)
where, J is the flux across the gut wall, Pw is the permeability
of the gut wall to the drug and Cw is the concentration profile at
the gut wall. In terms of BE, it is assumed that highly permeable,
highly soluble drugs housed in rapidly dissolving drug products
will be bioequivalent and that, unless major changes are made to
the formulation, dissolution data can be used as a surrogate for
pharmacokinetic data to demonstrate BE of two drug products. The
BCS thus enables manufacturers to reduce the cost of approving
Biopharmaceutics Classification System
Chavda HV, Patel CN1
, Anand IS2
Departments of Pharmaceutics and Pharmaceutical Technology, 1
Pharmaceutical Chemistry, 2
Pharmacology, Shri Sarvajanik
Pharmacy College, Hemchandracharya North Gujarat University, Nr. Arvind Baug, Mehsana, Gujarat - 384 001, India
Review Article
Correspondence:
Mr. Hitesh Chavda; E-mail: [email protected]
A R
framework for classifying drug substances based on their aqueous
solubility and intestinal permeability. This classification system
was devised by Amidon et al.
[1] This concept underlying the BCS
published finally led to introducing the possibility of waiving in vivo
bioequivalence (BE) studies in favor of specific comparative in vitro
testing to conclude BE of oral immediate release (IR) products with
systemic actions. The BCS has found international recognition
in industry, academic institutions and public authorities.[2] The
principle of the BCS is that if two drug products yield the same
concentration profile along the gastrointestinal (GI) tract, they will
result in the same plasma profile after oral administration. This
concept can be summarized by the following equation:[3]
J 5 PwCw (1)
where, J is the flux across the gut wall, Pw is the permeability
of the gut wall to the drug and Cw is the concentration profile at
the gut wall. In terms of BE, it is assumed that highly permeable,
highly soluble drugs housed in rapidly dissolving drug products
will be bioequivalent and that, unless major changes are made to
the formulation, dissolution data can be used as a surrogate for
pharmacokinetic data to demonstrate BE of two drug products. The
BCS thus enables manufacturers to reduce the cost of approving
Biopharmaceutics Classification System
Chavda HV, Patel CN1
, Anand IS2
Departments of Pharmaceutics and Pharmaceutical Technology, 1
Pharmaceutical Chemistry, 2
Pharmacology, Shri Sarvajanik
Pharmacy College, Hemchandracharya North Gujarat University, Nr. Arvind Baug, Mehsana, Gujarat - 384 001, India
Review Article
Correspondence:
Mr. Hitesh Chavda; E-mail: [email protected]
A R
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