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PHARMACY212 > Biopharmaceutical Classification > Flashcards

Biopharmaceutical Classification Flashcards

1
Q

What is the salt form of a drug?

A

A more soluble form of the drug that readily ionises in aqueous media

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2
Q

How does the BCS classify drugs?

A

Based on solubility and permeability

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3
Q

What is a sink condition?

A

The volume of solvent required for complete dissolution

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4
Q

What is Overton’s Rule?

A

Membrane permeability of a molecule increases with its hydrophobicity

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5
Q

What is Lipinski’s Rule of 5?

A

That the lipophilicity of an orally administered drug should not exceed 100000 (LogP <5)

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6
Q

What are the two parameters that determine drug absorption?

A

Solubility and permeability

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7
Q

What is a class I drug?

A

High permeability and high solubility

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8
Q

What is a class II drug?

A

High permeability, low solubility

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9
Q

What is a class III drug?

A

Low permeability, high solubility

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10
Q

What is a class IV drug?

A

Low permeability, low solubility

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11
Q

What is the bioavailability of a class I drug?

A

Well absorbed with fast absorption rate

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12
Q

What is the bioavailability of a class II drug?

A

Bioavailability is limited by their solvation rate

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13
Q

What is the bioavailability of a class III drug?

A

Absorption is limited by permeation rate, but has fast solvation

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14
Q

What is the conditions for pH-solubility testing?

A

1 to 7.5 at 37 degrees

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15
Q

Why are the conditions for solubility what they are?

A

That is the temperature and pH of the GIT

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16
Q

How do we determine intestinal permeability in vivo?

A

By testing with humans or with animals

17
Q

How do we determine intestinal permeability in vitro?

A

By using excised human or animal intestinal tissue

By doing experiments across epithelial cell layers

18
Q

What does it mean when a drug is highly soluble in the BCS?

A

Highest strength dose should be soluble in 250 mL of aqueous media over a pH range of 1-7.5 at 37

19
Q

Why is the graph of permeability and time not linear?

A

Because of the lag time (tL) required for a penetrant to establish a uniform concentration gradient within the membrane separating the donor from the receptor

20
Q

What is a bio-waiver?

A

An exemption from conducting human bioequivalence studies for new dosage forms

21
Q

What are the parameters for a bio-waiver?

A

Rapid and similar dissolution to a marketed formulation
High solubility
High permeability
Wide therapeutic window

PHARMACY212 (7 decks)

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