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Pharmacokinetics > Exam 3 > Flashcards

Exam 3 Flashcards

1
Q

Why do we need a pharmaceutical carrier?

A

protect drug from the body

protect body from the drug

Adjust PK, distribution and clearance

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2
Q

Biopharmaceutic Factors in Drug products

A

Stomach (Food effects)
Small intestine and Transit time (~3h)
Colonic transit (10-20hr)
Large Intestine

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3
Q

Adv Sustained Drug Delivery Tech

A 
Infusion
Oral
Topical
Inhalation
Injection
Percutaneous
Implantation
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4
Q

Advantages of ER/Sustained release products

A

Sustained therapeutic blood lvls of drug

Improved pt compliance

Reduction in adverse effects and improved tolerability

Reduction in HC costs

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5
Q

Disadvantages of ER products

A

Dose-dumping

Less flexibility in accurate dose adjustment

less possibility for high dosage

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6
Q

ER drug product definition

A

dosage form that allows at least a 2fold reduction in dosage frequency as compared to that drug presented as an immediate release dosage form

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7
Q

Delayed release drug product definition

A

Dosage form that releases a discrete portion/portions of drug at a time other than the promptly release after admin

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8
Q

Targeted release drug products definition

A

dosage form tat release drug at or near the intended physiological site of action

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9
Q

ODTs definiton

A

disintegrate rapidly in saliva after oral admin

used without water dispersed in saliva

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10
Q

Enteric coated definiton

A

type of delayed release designed to release drug in small intestine

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11
Q

Prolonged-action drug product

A

formulation whose drug activity can continue for a longer time than conventional drugs

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12
Q

Sustained-release drug product

A

designed to release a drug at predetermined rate for the constant drug conc maintaining during specific period of time

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13
Q

ideal ER drug product

A

release drug at constant rate

independent of pH, ionic content, other contents within GI tract

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14
Q

Amount of drug needed in sustained-release product to maintain therapeutic drug conc is dependent on both….

A

Vd and Elim 1/2 life

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15
Q

Five Types of Matrix Tablets

A
  1. Hydrophobic matrix (plastic)
  2. lipid matrix
  3. hydrophilic matrix
  4. biodegradable matrix
  5. mineral matrix
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16
Q

How can matrix be classified?

A

by porosity situation and also by usage frequency

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17
Q

Ion exchange products

A

insoluble drug complex containing the resin and drug dissociates in the GI tract in the presence of appropriate counter ions

drug dissolves in GI tract and is rapidly absorbed

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18
Q

Resin needed for anionic drugs?

A

positively charged

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19
Q

Resin needed for cationic drugs

A

Negatively charged

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20
Q

Core tablet

A

Core tablet within a tablet

Inner core suavely slow-release and outer shell is rapid release

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21
Q

Microencapsultion

A

process of encapsulating microscopic drug particles with a special caution material, making the drug particles more desirable in terms of physical and chemical characteristics

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22
Q

2 Important requirements in development of ER products are….

A

demonstration of safety and efficacy

demonstration of controlled drug release

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23
Q

Evaluation of modified released products

A

Dissolution studies

In vitro - In vivo correlations

PK studies

Clinical considerations of modified release drug products

Generic substitution of modified release drug products

24
Q

Evaluation of invivo bioavailability data

A 
PK profile
Steady-state plasma drug conc
Rate of drug absorption
Occupancy time
Bioequiv studies
Statistical eval
25
Q

Maintain particle size below what for liposome?

A

1 um

size affects RES uptake and tissue targeting

26
Q

Drug discovery Catch-22

A

Solubility is KEY, many candidates are insoluble so abandoned

Micelle formation might be possible solution to deliver poorly soluble drugs

27
Q

CMC

A

Critical Micellation Concentration determines stability

The lower the CMC, the more stable it is

28
Q

Fluctuations

A

Peaks and troughs in drug absorption profile

Peaks appear at time of dose, troughs appear before next dose

create a saw-tooth profile

29
Q

Accumulation

A

increase in magnitude of troughs and peaks w/ each dose

minimizes in each successive dose

30
Q

Steady state

A

occurs when drug accumulation between doses stops

peaks and troughs won’t change at steady state

input = output

31
Q

Average plasma conc

A

average plasma conc throughout therapy

shape is same as plasma conc-time profile of constant IV

32
Q

Major factors for multiple dosing therapy?

A 
How much (dose)
How often (frequency of drug admin)
How long (duration of therapy)
33
Q

Factors affecting accumulation?

A

Dosing interval (inversely related)(reducing interval time = increase drug accumulation)

Drug half life (directly related)(if long half life = major accumulation occurs)

34
Q

if T1/2 / t = 1 means that…

A

no accumulation

35
Q

if T1/2 / t > 1 means that…

A

accumulation is occurring

36
Q

if drug half life is short then……

A

accumulation is negligible

if T1/2 / t = <1

37
Q

If a drug has a very short half life, shorter than dosing interval then….

A

it will not accumulate

ie Gentamicin

38
Q

Time to reach steady state depends on…..

A

half life (for exam purposes)

39
Q

Fluctuation of Oral vs IV

A

Oral has lower fluctuation than IV

takes awhile to absorb and then slowly declines

40
Q

Absorption of most immediate release formulations is assumed to be….

A

instantaneous

41
Q

Gradual extravascular absorption produces a higer….

A

Min than that produced by IV bolus

42
Q

Fluctuation with reduced absorption will be….

A

minimal

43
Q

drugs administration by intermittent IV infusions

A

Aminoglycosides
vancomycin

given by 30-60 min infusions

44
Q

in intermittent infusion, cmax is reached when…

A

infusion is stopped

45
Q

in intermittent infusion, cmin is reached when…..

A

when the next dose given

46
Q

In intermittent infusions, the 2 conc measured are called….

A

peak and troughs

47
Q

How does AUC change in Non-linear Pharmacokinetics?

A

doesn’t increase linearly

48
Q

Causes of non-linearity

A

Absorption
Distribution
Renal excretion
Metabolism

49
Q

Most common form of non-linearity?

A

Capacity limited metabolism

occurs when therapeutic conc of drug saturate partially or completely an enzyme responsible for drug elim

50
Q

when C«< Km

A

its a first order process for metabolism

increase in drug conc will increase rate of metabolism

51
Q

when C»»> Km then

A

metabolism is 0 order process, elim rate is constant

52
Q

When C is around Km then metabolism is…

A

mixed order

53
Q

2 major compartments

A

Central and Peripheral

54
Q

Drug distribution form central to peripheral is….

A

first order

controlled by drug amount In central compartment

55
Q

Distribution or pseudo equilibrium is when…..

A

conc in central compartment equals conc in peripheral

56
Q

two important points that require special precaution of Multi-compartment kinetics for Lidocaine and Digoxin samples

A

Lidocaine collect sample at pre and post distribution phase

Digoxin samples collected after distribution phase

57
Q

if you ignore distribution phase you can have errors in…

A

AUC
Cl
V

Pharmacokinetics (4 decks)

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