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Flashcards in this deck (42)
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How does Passive Transport facilitate drug absorption?
Simple diffusion down a concentration gradient; it requires no energy input.
Facilitated diffusion requires energy
Active transport using energy
Requires membrane carrier proteins
drug_absorption transport -
What does Fick's Law describe?
The process of ionization.
The rate of diffusion.
The energy required for transport.
The speed of dissolution.
fick's_law diffusion -
noyes_whitney dissolution
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What equation describes how dissolution rate increases with higher solubility?
Noyes-Whitney equation.
Fick's Law equation.
Henderson-Hasselbalch equation.
Beer-Lambert Law.
noyes-whitney dissolution equation -
Why do drugs in ionized form have increased dissolution?
They are solid drugs.
Ionized drugs are hydrophilic and dissolve easily.
They require energy.
They are small and lipophilic.
drug_solubility dissolution -
How does normal blood flow impact drug absorption?
It slows down drug passage.
It decreases tissue concentration.
It enhances ionization.
It creates a steep concentration gradient.
blood_flow drug_absorption -
What affects drug permeability aside from solubility?
Route of administration only.
Time until absorption.
Molecular weight only.
Ionization and lipophilicity.
drug_permeability absorption -
How is solubility related to the isoelectric point (pI)?
pI cannot be defined.
Solubility is unrelated to pI.
Solubility is lowest at pI and increases on either side.
Solubility is highest at pI.
solubility isoelectric_point -
Using Henderson-Hasselbalch, what form does an acidic drug with pKa 5 take in the stomach?
Protonated form.
Ionized form.
Dissolved form.
Equal forms.
henderson-hasselbalch drug_ionization -
How does slow blood flow impact drug absorption?
It decreases drug solubility.
It increases the concentration difference.
It enhances drug removal rate.
It flattens the diffusion gradient.
slow_blood_flow drug_absorption -
pharmacology weak_acids
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In which environment do weak acids get better absorbed?
Basic environment
No specific environment
Neutral environment
Acidic environment
absorption weak_acids -
What is the predominant form of a weak acid drug in the stomach?
Neutral form
Ionized form
Protonated form
Unionized form
pharmacology absorption -
What happens to a weak acid drug in the intestines?
It becomes unionized.
It gets eliminated.
It remains unchanged.
It becomes ionized.
absorption weak_acids -
pharmacology weak_bases
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In which environment do weak bases get better absorbed?
Neutral environment
No specific environment
Acidic environment
Basic environment
absorption weak_bases -
What is the ionic form of a weak base drug in the stomach?
Ionized form
Unionized form
Neutral form
Protonated form
pharmacology absorption -
How much does the surface area of a drug crystal increase when reduced from 5 µm to 1 µm?
300%
600%
400%
500%
pharmacology surface_area -
What is the Noyes-Whitney equation related to?
Volume measurement
Ionization only
Drug synthesis
Dissolution and absorption
formulation dissolution -
What does BCS stand for?
Bioavailability Characterization System
Basic Classification System
Biopharmaceutics Classification System
Biological Control System
classification pharmacology -
What are the characteristics of BCS Class I?
High solubility, high permeability
High solubility, low permeability
Low solubility, low permeability
Low solubility, high permeability
bcs pharmacokinetics -
What is the rate-limiting step in BCS Class II drugs?
Metabolism
Distribution
Absorption
Dissolution
bcs pharmacokinetics -
What type of drug form is an example of BCS Classification I?
Gel form
Crystalline form
Liquid form
Amorphous form
drugforms bcs -
What describes an amorphous drug form?
Gel form
Non-crystalline, high-energy solid
Crystalline, low-energy solid
Liquid form
drugforms amorphous -
What is a characteristic of crystalline drug forms?
Unstable high-energy solid
Stable low-energy solid
Dissolves rapidly
Non-crystalline liquid
drugforms crystalline -
Why might tablets have lower bioavailability than solutions?
Tablets are liquid
Tablets are absorbed faster
Tablets must dissolve before absorption
Solutions are more stable
bioavailability tablets -
What is first-pass metabolism?
Direct absorption into bloodstream
Metabolism in stomach
Extended release from muscle
Drug metabolism in the liver after oral intake
first_pass metabolism -
What are the two most important parameters for estimating bioequivalence?
AUC and Cmax
Tmax and clearance
Dosage and half-life
Volume of distribution and bioavailability
bioequivalence parameters -
What does AUC stand for?
Area Under the Curve
Assessed Undissolved Compounds
Amount of Unique Compounds
Average Usage of Concentration
auc pharmacokinetics -
What is plotted on the y-axis of the AUC curve?
Time
Amount of drug in blood
Drug half-life
Concentration in tissue
auc pharmacokinetics -
What does a larger AUC indicate?
Slower elimination
More drug absorbed
Same drug absorption rate
Less drug absorbed
pharmacokinetics auc -
What does the term 'Cmax' refer to?
Peak concentration of a drug in systemic circulation
Total drug exposure
Half-life of the drug
Elimination rate
pharmacokinetics cmax -
What is bioequivalence?
Same brand name
Different side effects
Same chemical structure
Two drug products have no clinically meaningful difference in absorption
bioequivalence drugs -
What is the criteria for bioequivalence according to the FDA?
90% Confidence Interval (CI) within 0.8 - 1.25
85% CI within 0.7 - 1.2
80% CI within 0.9 - 1.3
95% CI within 1.0 - 1.5
fda bioequivalence -
In bioequivalence testing, what is measured?
Drug side effects
Patient symptoms
Blood concentrations over time
Time taken for dosage
bioequivalence pharmacokinetics -
What would signify that drugs are bioequivalent?
Only generic drugs can be compared
Cmax values must be identical
Drugs must be chemically identical
Ratios of AUCs fall within 80% to 125%
bioequivalence drugs -
What defines pharmaceutical equivalents?
Same formulation
Different active ingredients
Different dosages
Same active ingredient, different excipients
pharmaceuticals equivalence -
Why might a bioequivalent drug not be therapeutically equivalent?
Efficacy requires additional measure assessment
They have the same brand name
They are manufactured in the same facility
They must contain the same side effects
bioequivalence therapeutics -
What does an AA rating signify?
No known bioequivalence problems
Bioequivalent product after studies
Requires further studies
Substitutable with any generic
pharmaceutical ratings -
What does an AB rating indicate?
Bioequivalent product after studies
No known bioequivalence problems
Not interchangeable with other drugs
Requires prior approval
pharmaceutical bioequivalence -
What is the significance of the numbers in AB codes?
AB codes represent the same drug
All AB codes are interchangeable
AB1 does not equal AB2 that does not equal AB3
Both AB1 and AB2 are the same
pharmaceutical ab_codes -
For a generic drug to be substitutable, what must it match?
The same-number reference drug
Any available generic
The highest-rated drug
Any reference drug
pharmaceutical substitutability
Passive and Active Transport in Drug Absorption
Passive Transport
- Simple Diffusion: Moves drugs down a concentration gradient without energy.
Active Transport
- Facilitated Diffusion: Protein channels used, no energy required, moves down the gradient.
- Active Transport: Requires energy, moves against the concentration gradient.
Key Laws in Drug Absorption
Fick's Law of Diffusion
- Rate of diffusion increases with a larger concentration gradient, thinner membrane, and greater surface area.
Noyes-Whitney Equation
- Describes the dissolution process and factors that affect it, such as surface area and solubility.
Dissolution and Ionization
Dissolution Defined
- Ability of a drug to dissolve in solution affected by pH.
Ionization and Absorption
- Ionized drugs are hydrophilic and dissolve better, while protonated drugs are lipophilic and more likely to permeate membranes.
Factors Affecting Drug Absorption
General Factors
- pH level and ionization form of the drug affect solubility and absorption.
- Larger surface area and smaller particle size increase absorption rates.
Blood Flow Impact
- Normal Blood Flow: Fast absorption, steep concentration gradient.
- Slow Blood Flow: Flattens the diffusion gradient, reducing absorption.
Drug Forms and Bioavailability
Amorphous vs. Crystalline Forms
- Amorphous: High energy, fast dissolution; Crystalline: Low energy, slower dissolution.
First-Pass Metabolism
- Drug metabolizes in the liver before reaching systemic circulation, reducing bioavailability.
BCS Classification
Class I
- High solubility and permeability; fast absorption.
Class II
- Low solubility and permeability; dissolution is the rate-limiting step.
Understanding Bioequivalence
Bioequivalence Definition
- Drugs show no meaningful difference in absorption rate and extent (AUC, Cmax).
Evaluating Bioequivalence
- Measured by concentration-time curves in clinical trials. Must fall within an 80-125% confidence interval.
Pharmacokinetics Overview
- Represents absorption, peak concentration (Cmax), elimination, and area under the curve (AUC).