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Dosage Forms II RH > Exam 2 - Lectures 1 and 2 > Flashcards

Exam 2 - Lectures 1 and 2 Flashcards

1
Q

what was the NECC 2012 tragedy?

A

it was an outbreak of fungal meningitis among patients who had received contaminated steroid injections from the New England Compounding Center. It led to several deaths and triggered changes in federal law

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2
Q

which USP chapter pertains to sterile pharmaceutical compounding?

A

USP <797>

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3
Q

which USP chapter pertains to parenterals “Hazardous drugs - handling in healthcare settings?”

A

USP <800>

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4
Q

USP chapters with number > 1000

a. recommendations
b. must be followed

A

a. recommendations

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5
Q

USP chapters with number < 1000

a. recommendations
b. must be followed

A

b. must be followed

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6
Q

parenteral means ?

A

other than through the GI tract (i.e. injectables)

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7
Q

3 requirements of all parenterals

A

-sterile
-free of particles
-free of pyrogens (substances that can produce fever)

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8
Q

non-sterile hazardous USP (2)

A

USP 795 and 800

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9
Q

non-sterile non-hazardous USP

A

USP 795

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10
Q

sterile non-hazardous USP

A

USP 797

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11
Q

sterile hazardous USP (2)

A

USP 797 and 800

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12
Q

risk of harm to the patients comes from what 5 things? (slide 25)

A
  1. microbial contamination
  2. excessive bacterial endotoxins
  3. variability in the intended strength of correct ingredients
  4. unintended chemical and physical contaminants
  5. ingredients of inappropriate quality
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13
Q

5 methods of sterilization in sterile compounding (slide 26)

A
  1. steam (autoclave)
  2. filtration (bacteria retentive membrane)
  3. dry heat (oven)
  4. gas (ethylene oxide)
  5. irradiation (gamma rays)
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14
Q

where do pyrogens come from?

A

for the most part, they are remnants from microorganisms

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15
Q

septicemia vs septic shock

A

Septicemia is an infection of the blood. Septic shock is an acute reaction to bacterial endotoxins

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16
Q

why do we want sterile compounding preparations to be particle free?

A

foreign particles can trigger immune response and can produce damage to the lungs, kidneys, and can kill people

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17
Q

what is the difference between a “drug injection” and a “drug for injection”?

A

a “drug for injection” needs to be reconstituted before it is ready for use. Don’t use as is. Can be dry solid or liquid preparation

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18
Q

large volume parenteral are single dose injections packaged in a container containing more than ___ mL?

A

100 mL

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19
Q

small volume parenterals are less than ___ mL

A

100 mL

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20
Q

what is the most common vehicle used in parenteral products?

A

water

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21
Q

what is a “vehicle” in a parenteral product?

A

solvents or mediums for the administration of therapeutic agents

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22
Q

3 primary types of water used in parenteral products

A

-water for injection USP (WFI)
-sterile water for injection USP (SWFI)
-bacteriostatic water for injection USP (BWFI)

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23
Q

sterile water for injection is pyrogen free, sterile, and packed in sealed containers not larger than how many mL?

A

1000 mL

24
Q

true or false: it is ok to inject sterile water for injection (SWFI) directly into the bloodstream

A

false

(Never inject SWFI directly into bloodstream. Water is hypotonic (need isotonic), so if we inject it will produce lysis of the cells)

25
Q

4 pros of IV drugs (slide 4; lecture 2)

A

-very rapid
-straight to the blood
-good for irritant drugs
-suitable for large volumes

26
Q

which parenteral route of administration is the “least forgiving”?

a. IM
b. SubQ
c. intradermal
d. IV
e. intraperitoneal
f. intraspinal

A

d. IV

27
Q

IV preparations are mainly _____ but there are also IV _____

A

solutions; emulsions

28
Q

true or false: parenteral products must be isotonic and at physiological pH

A

false

(these qualities are highly desirable but not mandatory)

29
Q

true or false: intra-spinal injections must be isotonic, at physiological pH, and have no preservatives

A

true

30
Q

2 most common aqueous isotonic vehicles

A

0.9% (w/v) NaCl solution (normal saline)
5% (w/v) Dextrose solution (D5W)

31
Q

bacteriostatic sodium chloride injection is normal saline with:

a. antimicrobial preservatives
b. K+ and Ca2+ in approx physiological concentrations

A

a. antimicrobial preservatives

32
Q

Ringer’s solution is normal saline with:

a. antimicrobial preservatives
b. K+ and Ca2+ in approx physiological concentrations

A

b. K+ and Ca2+ in approx physiological concentrations

33
Q

3 isotonic vehicles that are both sterile AND isotonic

A

NS (Normal Saline)
D5W (5% Dextrose in Water)
D2.5W/1/2NS (2.5% Dextrose in half normal saline)

34
Q

3 water miscible solvents (cosolvents) (slide 10; lecture 2)

A

ethyl alcohol
polyethylene glycol (PEG)
propylene glycol (PG)

35
Q

PEG can be used IV at concentrations as high as ___% (v/v)

A

40 %

36
Q

ethyl alcohol can be used IV at concentrations up to ~ ___% (v/v)

A

10%

37
Q

which is ok for IV injection: straight liquid oil or an oil emulsion?

A

an oil emulsion

(there is risk of embolism if straight liquid oil is injected)

38
Q

true or false: an emulsion contains oil, but it is not oil

A

true

(oil is an ingredient in it)

39
Q

do we use antimicrobial preservatives in single dose or multiple dose preparations?

A

multiple dose

40
Q

what is the most common preservative?

A

benzyl alcohol 0.9%

41
Q

3 antimicrobial preservatives (slide 14; lecture 2)

A

benzyl alcohol 0.9%
parabens
cresol

42
Q

Some excipients inactivate (“sequester”) antimicrobial preservaties. How do polysorbate and PVP do this?

A

polysorbate - through micelles
PVP - complex-like formation

43
Q

true or false: you can use benzyl alcohol in neonates

A

false

(Don’t use in neonates. Respiratory system is not fully developed, so if they have trouble breathing they can start choking due to lack of oxygen)

44
Q

true or false: preparations intended for the intra-spinal route must contain antimicrobial preservatives

A

false

(must be free of preservatives in intra-spinal)

45
Q

why do we have pH buffers in a parenteral product?

A

to address solubility and/or stability issues with the drug

46
Q

commonly used pH buffers (3 of them; slide 20; lecture 2)

A

-citrates (safe by IV, very irritating by IM or SC)
-acetates
-phosphates (considerable caution. Potentially fatal)

47
Q

_______ and _______ combined have a strong tendency to precipitate and the result can be fatal

a. potassium; sodium
b. potassium; calcium
c. phosphate; sodium
d. phosphate; calcium

A

d. phosphate; calcium

48
Q

4 antioxidants (slide 25; lecture 2)

A

metabisulfite salts - low pH
bisulfite - intermed pH
sulfite - high pH
ascorbic acid (vitamin C)

49
Q

glycerol is an example of what component of a parenteral product?

A

tonicity agent

50
Q

_____ is arguably the most commonly used material for containers (gradually being replaced by _____ )

A

glass; plastic

51
Q

which of the 3 types of glass do we normally use?

A

type I

(there are 3 types: type I, II, III)

52
Q

what material are ampules made out of?

A

glass

53
Q

what is a drop number/factor?

A

the estimated number of drops it takes to make up one mL of fluid

54
Q

what kind of syringes are required for hazardous drug compounding?

A

Luer Lok (plus Luer Tip)

55
Q

what does a 18G3” needle mean?

A

18 gauge refers to the diameter. The smaller the gauge, the thicker it is. 3” refers to a 3” needle shaft length

Dosage Forms II RH (7 decks)

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