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Pharmaceutics Spring 2016 > Parenterals Part B > Flashcards

Parenterals Part B Flashcards

1
Q

Total parenteral nutrition (TPN)

A

-used to provide nutrients to patients who can not take in nutrients orally

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2
Q

TPNs typically contain: (3)

A
  • carb (dextrose)
  • lipid (fat)
  • amino acid (protein)
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3
Q

Base solutions are known as….

A

Macronutrients (amino acid solutions, dextrose, IV fat)

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4
Q

TNA or three in one admixture contain (3)

A
  • IV emulsion
  • amino acid
  • dextrose
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5
Q

What is the problem with 3 in 1 admixtures?

A

emulsions are typically opaque (milky white) which makes it hard to see incompatibilities

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6
Q

If TPN is going to be going on for a while you may need both….

A

macronutrients and micronutrients

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7
Q

micronutrients are known as

A

electrolytes

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8
Q

What is the problem with using high concentrations of dextrose?

A

it is no longer isotonic, but hypertonic

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9
Q

T/F You only want to use manual compounding if it is required. Automated is better.

A

TRUE

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10
Q

TPN manual Gravity method for compounding?

A

special IV bag with transfer leads attached

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11
Q

TPN automated compounding? (2)

A
  • saves time

- reduces potential error and contamination

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12
Q

Sterilization?

A

the complete destruction of all living organisms and their spores

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13
Q

Methods used for sterilization (5)

A
  • steam sterilization
  • dry heat sterilization
  • sterilization by filtration
  • gas sterilization
  • ionizing radiation
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14
Q

SAL abbreviation?

A

Sterility assurance level

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15
Q

What is the SAL of terminal sterilization?filter sterilization?

A

terminal: 10^-6 (1 in a million)
filter: 10^-3 (1 in a thousand)

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16
Q

T/F Filter Sterilization is terminal sterilization

A

FALSE: IS NOT

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17
Q

Steam Sterilization is also known as …..

A

autoclaving (the best method)

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18
Q

T/F Autoclaving does not destroy pyrogens

A

TRUE; the material is pyrogen free due to distillation that uses WFSI

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19
Q

Steam Sterilization (2)

A
  • moist heat causes denaturation of proteins

- saturated steam under pressure in autoclave 121 degrees celsius

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20
Q

Which of the following ampuls can be sterilized in an autoclave machine?

  • drug in oil
  • drug in WFSI
A

drug in WFSI because it makes its own pressure causing the pressure to be the same on the inside and outside of the ampul

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21
Q

T/F Dry Heat sterilization uses a higher temperature for a longer period of time than steam sterilization

A

TRUE

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22
Q

Dry Heat Sterilization (3)

A
  • dehydration follow by oxidation
  • removes pyrogens
  • glassware can be covered w/aluminum foil and sterilized
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23
Q

Which of the following ampuls can be sterilized in by dry heat?

  • drug in oil
  • drug in WFSI
A

drug in oil

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24
Q

Filtration Sterilization (3)

A
  • suitable for heat sensitive material (protein)
  • does not remove pyrogens
  • physical removal of microorganisms by 0.2 micron membrane filter
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25
What tests checks the integrity of the filter (makes sure there is no breaks in the filter)?
Bubble point test | Pressure hold test
26
Gas sterilization (2)
- exposure to ethylene oxide gas diluted with an inert gas | - for heat and moisture sensitive material
27
In a gas chamber during sterilization what is controlled? (4)
- temperature - humidity - gas concentration - exposure time
28
Ionizing Radiation Sterilization (2)
- gamma radiation from cobalt-60 | - used for medical devices and hospital supplies
29
Sterilization needs to be validated, how is this possible? (4)
- biological indicators - recording thermocouples - color change indicators - melting indicators
30
What does the USP 797 classify CSP as low risk? (2)
- made outside the PEC and is intended for emergency use | - administration must be given no later than 1 hour
31
T/F Low risk CSPs are prepared from sterile commercial ingredients using sterile commercial devices, maintained in an ISO Class 5 environment
TRUE
32
What does the USP 797 classify CSP as medium risk?
making a TPN (going in a lot of times)
33
What does the USP 797 classify CSP as high risk?
Compounding sterile preparations from non-sterile ingredients is always categorized as high risk compounding
34
The facility design that is desired for CSP?
has ISO class 5 PEC, and ISO class 7 and class 8 (has pressure differientation)
35
Sterility Test (2)
- primarily used as a check test | - direct inoculation and membrane filtration method
36
When is a product deemed to pass sterility test?
if all media vessels incubated with product sample reveal no evidence of microbial growth (turbidity)
37
T/F Pyrogens are endotoxins
TRUE
38
Endotoxins (5)
- gram negative - potent - very stable - will pass through 0.2 um filters - not destroyed by autoclaving
39
What tests can be used for pyrogen testing?
rabbit test or LAL test kit
40
Air sampling methods? (3)
- settling plates - electronic air particles counters - centrifugal air sample
41
Settling plate method
will see colonies of bacteria if infected
42
Electronic air particle counter
count viable and nonviable
43
Surface sampling methods? (2)
- rodac plates (convex surface) | - swab-rinse test
44
T/F Most common drug products are COMPATIBLE when added to common LVP vehicles
FALSE: An estimated 30% of common drug products are incompatible or unstable when added to common LVP vehicles
45
-change in color or appearance -change in acid-base environment -pH of things being mixed -solubility problems Are what type of incompatibilities?
physical
46
-hydrolysis -oxidation (may result in color change) -photolysis (light), complexation -compatibility of preservative Are what type of incompatibility?
chemical
47
To avoid precipitation what can be done?
changing the order of mixing
48
For CSP, media fills should be performed...
at least annually for each person authorized to compound | -semiannually for high risk
49
T/F Personnel glove fingertip sampling is REQUIRED
TRUE
50
Automated Compounding Devices are used to make
TPNs
51
For cytotoxic drugs you should use _____ flow, to protect the product, person, and the environment
vertical; via the biological safety cabinet
52
T/F You SHOULD put air in the vial for chemo drugs.
FALSE; You DO NOT put air in the vial for chemo drugs because it may squirt out
53
Chemo dispensing pins are used.....
for cytotoxic drugs to keep pressure in equilibrium
54
What are 3 PECs?
- biological flow hood - laminar flow hood - barrier isolator
55
Needle free injections are useful for?
mass vaccination
56
microsphere formation
drug is dispersed in a polymer matrix (this is used for proteins since they have a short half life)
57
CLASS ACTIVITY: Microspheres are typically around 100um, how can they be administered parenterally?
-can give SubQ or IM (just needs to be sterile)
58
___ is the primary extracellular cation -important to maintain normal extracellular fluids
Sodium
59
___ is the primary intracellular cation -balance is important to avoid hypo and hyper kalemia
Potassium
60
Potassium preparations must be....
diluted and given by slow IV infusion otherwise it could cause cardiac arrest
61
T/F Bicarbonate balance includes consideration of acid-base balance and acidosis/alkalosis. Chloride ion is also important to maintain the acid-base balance
TRUE
62
Irrigation and dialysis solutions are...
employed outside the circulatory system but still need to be sterile
63
_______ solutions are used to bathe or wash wounds, surgical incisions, or body tissues
irrigation

Pharmaceutics Spring 2016 (20 decks)

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