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Y2S1 302 > 10+11: Drug Stability and Expiration Date > Flashcards

10+11: Drug Stability and Expiration Date Flashcards

1
Q

when drugs are repackaged or handled, what happens to their shelf life?

A

shortened

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2
Q

a sterile eye drop is repackaged from a multiple dose dropper into a minum, what is the new shelf life

A

24h

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3
Q

a sterile solution is repackaged from a large vial into a unit dose syringe, it must be used within

A

24hrs

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4
Q

the shelf life of a product is the time period in which it must remain within its approved specification under recc conditions. what is approved specification

A

90% of labeled quantity

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5
Q

path for dosage form manufacturing

A

bulk drug
manufacturing
pharmaceutical company
pharmacy patient possession

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6
Q

how long can eyedrops be used after opening the dropper

A

1 month

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7
Q

list the 5 types of instability

A 
physical
chemical 
microbial
therapeutic
toxicological
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8
Q

what are the 3 most vulnerable dosage forms to physical instability

A

emulsions
semisolids
suspensions

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9
Q

what is a common sign of physical instability in tablets

A

fog or liquid droplets, crystal formation in package, swelling, fusion between tablets

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10
Q

what is a common sign of instability in suppositories

A

softening or hardening, oil stains

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11
Q

describe polymorphic transformation

A

crystalline structure to amorphous structure or crystalline structure to another crystalline stucture

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12
Q

polymorphic transformation happens due to

A

heat, pressure, humidity

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13
Q

a tablet looks the same as before, but with lower solubility, what instability may have happened

A

polymorphic transformation

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14
Q

what is pseudopolymorphism

A

solvated to nonsolvated form- drug loses crystalline water in their structure

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15
Q

what is aging in physical instability

A

changing in disintegration/ dissolution of dosage forms

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16
Q

what is the most common cause of precipitation

A

change in pH

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17
Q

list 4 reasons for precipitation

A

change in pH
dilution of cosolvent during storage
complexation
salting out by addition of electrolytes

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18
Q

stability in aq solution varies with ___ (3 things)

A

concentration
solution
container

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19
Q

how to slow down physical instability

A

production
packaging
storage conditions

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20
Q

what is buffer capacity

A

ability o fbuffer to resist change in pH

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21
Q

what is buffer capacity and how can we increase it

A

ability of buffer to resist change in pH

greater the concentration, greater the resistance

22
Q

oxidation results in a loss of

A

electrons

23
Q

list some methods to prevent oxidation

A 
light resistant packaging
film coating
tablets
insert gases
chelating agents
antioxidants
24
Q

how to reduce the risk of hydrolysis

A

determine the pH of max stability and use a buffer to keep it there

25
Q

what is the pH range for acetate buffer

A

3.6-5,6

26
Q

besides, adding a buffer, what else can we do to reduce the risk of hydrolysis

A 
add nonaqueous solvents
add surfactants
convert to less soluble salts
formulate as a suspension
choose solid dosage forms
27
Q

oxidation of catalyzed by

A

metabolic elements

28
Q

products of oxidation are usually ________ and may be promoted by ________

A

coloured

light (photooxidation)

29
Q

list 3 antioxidants

A

oygen scavengers
chain terminators
reducing agents

30
Q

name an aqueous and an oil system antioxidant

A

ascorbic acid

ascorbyl palmitate

31
Q

tocopherol is a

A

oil system antioxidant

32
Q

what drugs / FGs are susceptible to photolysis

A

aromatic hydrocarbon groups, heterocyclic analogs, aldehydes, ketones

33
Q

drugs that absorb light <280nm decompose in _____ while drugs that absorb light >400nm decomposed in _______

A

sun light

sunlight and room light

34
Q

what is the difference between chemical and physical dehydration

A

physical dehydration = lose water from drug crystals

chemical = lose water from drug structure

35
Q

T or F: racecmization can change ADME

A

T

36
Q

racemization is usually catalyzed by

A

acid or base

37
Q

a drug becomes racemized and has a long half life, what will this affect

A

stability

38
Q

a drug is racemized and has a short half life, what will this affect

A

stability and pharmacology

39
Q

T or F: drug excipient incompatibilities may occur

A

T

40
Q

a solution of acids in a clear bottle has changed from clear to yellow tinged. What is likely the degradation process

A

chemical- oxidation

41
Q

zero order reactions rates are _____ of concentration

A

independent

42
Q

what type of formulations have zero order degradation kinetics

A

suspensions

43
Q

what types of formulations have first order degradation kinetics

A

solutions

44
Q

in the hydrolysis of ampicillin, why is the rate not also dependent on water? making it a second order reaction?

A

water is so much in excess it doesn’t matter

45
Q

rate of a second order reaction depends on

A

concentrations of both reactants

46
Q

what are some additives that would affect degradation rate

A

buffers
surfactants
antioxidants
chelating agents

47
Q

with a 10C increase in temperature, we see a ____ times increase in reaction rate

A

2-3x

48
Q

what are accelerated tests of stability

A

studies designed to increase the rate of chemical degradation or physical change using exaggerated storage conditions

49
Q

2 methods for accelerated tests of stability

A

arrheanius method

amirjahed method

50
Q

how to do the arrheanius method

A

see degradation of drug at different temps, then plot the graph and calculate k
plot a second graph of logK vs temp and extrapolate to wanted temp for k

51
Q

find drug % decline at different temperatures, plot days to 90% vs temperature and extrapolate
describes which method

A

amirjahed

52
Q

for approximation purposes, what is Q10

A

3

Y2S1 302 (10 decks)

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