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Pharmaceutics FINAL > Chapter 15 - Parenterals Part 2 > Flashcards

Chapter 15 - Parenterals Part 2 Flashcards

1
Q

name the 3 categories of nonaqueous vehicles for injections

A

-fixed oils
-water miscible susbtances
-other

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2
Q

name the requirements for fixed oils as nonaqueous vehicles for injection

A

-must be of VEGETABLE ORIGIN
-must be LIQUID at room temperature (unsaturated)
-not be free acids – causes muscle irritation

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3
Q

give 4 examples of fixed oils

A

corn oil
cottonseed oil
peanut oil
sesame oil

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4
Q

name 4 water miscible substances that are used as nonaqueous vehicles for injection

A

glycerin
polyethylene glycols
propylene glycol
alcohols

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5
Q

name the “other” nonaqueous vehicles for injection (not the fixed oils or water miscible substances)

A

they are used rarely

ethyl oleate
isopropyl myristate
dimthylacetamide

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6
Q

name 5 added substances to parenteral injections

A

the drug
isotonic agents
buffer agents
antimicrobial agents
antioxidants

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7
Q

the USP requires that 1 or more suitable substances be added to parenteral products that are packaged in ________ containers.
why?

A

multi-dose
to prevent the growth of microorganisms

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8
Q

name 2 isotonic agents

A

NaCl, dextrose

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9
Q

name 2 antimicrobial agents (preservatives)

A

thimerosal, benzyl alcohol

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10
Q

name 2 antioxidants used in parenteral preparations.
are they aqueous or oleaginous

A

sodium bisulfite
ascorbic acid

both aqueous

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11
Q

why are buffering agents used?

A

to prevent chemical degradation through hydrolysis,etc.

enhances stability

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12
Q

define sterility

A

the absence of life

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13
Q

define sterilization

A

the complete destruction of all viable microorganisms

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14
Q

what is a disinfectant

A

a substance used on inanimate objects to render them noninfectious

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15
Q

what is an antiseptic

A

a substance used to prevent sepsis

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16
Q

what is a pyrogen

A

a fever-producing substance

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17
Q

name 4 important considerations in sterilization

A

-the application of an adequate sterilization treatment

-verifying that the materials are sterile through the use of this treatment

-protect the sterile material

-delivery, opening, and use of the sterile material without entrance of contamination

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18
Q

name 5 methods of sterilization

A

-steam sterilization
-dry heat sterilization
-sterilization by filtration
-gas sterilization
-sterilization by ionizing raditiation

steam
dry heat
filtration
gas
ionizing raditation

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19
Q

what is the most RELIABLE method of sterilization to destroy all forms of microorganisms

A

steam sterilization

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20
Q

explain the method of steam sterilization and how it kills the bacteria.

A

called autoclaving – moist heat in the form of saturated steam under pressure

in the presence of this moisture, the bacterial proteins coagulate and get destroyed at a considerably lower temp than if moisture was not present

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21
Q

which are harder to destroy in steam sterilization – bacteria or spores?
explain

A

spores

bacterial cells have more moisture and are killed easier. spores have a relatively low percentage of water so are more difficult to destroy

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22
Q

what is the purpose of applying pressure in steam sterilization? what actually kills the microorganisms?

A

the purpose of applying pressure is simply to raise the temperature, not for the actual purpose of applying pressure

the temperature destroys the microorganisms, not the pressure

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23
Q

in steam sterilization, the greater the pressure applied, the _______ the temperature

A

greater pressure applied = higher temperature

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24
Q

in steam sterilization, name the 3 usual pressures applied, and their corresponding temperature and amount of time

A

115.5 degrees celsius for 30 minutes at 10psi
121.5 degrees C for 20 minutes at 15psi
126.5 degrees celsius for 15 minutes at 20psi

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25
Q

Steam sterilization is applicable to which pharmaceutical products?

A

those that can withstand the required temperatures and can be PENETRATED by the moisture but are NOT adversely affected

sealed containers such as ampuls are readily sterilized by this method.

sealed empty vials can only be sterilized through autoclaving if they contain a small quantity of water

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26
Q

differentiate between the steam sterilization capabilities of aqueous and oleaginous solutions

A

aqueous – the moisture is already present. just need to raise the temp for sterilization

oleaginous – cannot be done. no moisture present – may be damaged by the applied moisture

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27
Q

can steam sterilization be used on bulk solutions, glassware, and surgical dressings and instruments?

A

yes

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28
Q

steam sterilization can NOT be used on/…..

A

oils, fats, oleaginous preparations, and other preparations not penetrated by moisture

OR for exposed powders – may be damaged by the condensed moisture

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29
Q

dry heat sterilization uses what equipment to complete its task?

A

sterilizing ovens

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30
Q

how do microorganisms die in dry heat sterilization?

A

through oxidation

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31
Q

which is more effective in killing microorgansims – dry heat or moist heat?

A

moist heat

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32
Q

name the products that dry heat sterilization is good for

A

dry glassware, petroleum jelly, mineral oils, talcum powder, and some dry powders

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33
Q

explain the temperature and time period for dry heat sterilization

A

150 - 170 degrees celsius for at least 2 hours

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34
Q

which is the method of choice for when dry apparatus and containers are required, as in the handling of packages of dry chemicals and nonaqueous solutions —- steam sterilization or dry heat sterilization?

A

dry heat

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35
Q

which has higher temps and longer periods of exposure and WHY:

steam sterilization or dry heat sterilization

A

dry heat — less effective in killing microorganisms so needs higher temp and longer duration

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36
Q

what is a major disadvantage of dry heat sterilization

A

not all drugs remain stable at such a high temperature

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37
Q

sterilization by filtration is used for what?

A

solutions that can’t be heated

38
Q

sterilization by filtration is accomplished how?

A

by using one of the several bacterial filters.
they work by interlacing pores and bacteria/particles become trapped in these pores and are removed

39
Q

name 5 advantages of sterilization by filtration

A

-speed in filtering small quantities of solution
-ability to sterilize thermolabile materials
-inexpensive
-development and proliferation of membrane filter technology
–complete removal of both living and dead microorganisms and other particulate matter from solution

40
Q

_____micron (micrometer) filters reduce the in vitro antimicrobial activity of…….
while filtration through ____ did not

A

0.22 micron, amphotericin B (a colloidial susoension)

while filtration of amphotericin B through 0.85 and 0.45 micron filters did not

41
Q

give a specific example of a filter unit

A

MILLEX

42
Q

Explain how gas sterilization works

A

destroys all living microorganisms with a chemical in the GASEOUS or VAPOR state

some chemicals used” ethylene oxide, propylene oxide

43
Q

some ____ sensitive and ___ sensitive materials can be sterilized much better through gas sterilization

A

heat sensitive and moisture sensitive – big advanateg

44
Q

besides the fact that it can sterilize heat and moisture sensitive materials, give another major advantage of gas sterilization

A

ethylene oxide gas has great PENETRATING abilities. thus, it is a useful agent to sterilize medical and surgical supplies such as catheters, plastic disposable syringes, etc

45
Q

explain how sterilization by ionizing radiation works

A

uses either UV light or gamma radiation – still subject to investigation on how it actually works

46
Q

name a disadvantage of sterilization by ionizing radiation

A

application of these techniques is limited because of the highly specialized equipment required and the effects of irradiation on the products and their containers

47
Q

in the biological indicator for the validation/verification of sterility, what does A represent and what does B represent?

A

A = initial microbial population
B = number of microorganisms that survive after a defined heating time

48
Q

what do pyrogens cause?

A

febrile reactions

49
Q

what are endotoxins?

A

a subset of pyrogens that come from gram NEGATIVE bacteria

50
Q

differentiate between endotoxins and lipopolysaccharide

A

endotoxins are the NATURAL complex of LPS whereas LPS is the purified form, used as a standard for quality control and research purposes

51
Q

do gram positive bacteria have endotoxins, exotoxins, or both

A

just exotoxins

52
Q

name 2 ways in which pyrogens are destroyed

A

-heating at high temp (250 degrees celsius for 4 hours)

-a potassium permanganate/barium hydroxide filter (oxidize them – they’re organic)

53
Q

explain and name the USP pyrogen test

A

called the USP rabbit test.

uses healthy rabbits that have been properly maintained, and whose base temperatures differ no more than 1 degree celsius

heat the syringes, needles, and glassware at 250 degrees celsius for at least 30 mins to make them “pyrogen free”
warm the product to be tested as well

inject into each rabbit and record temps ever 30 mins hours 1-3

if no rabbit shows rise in temp above 0.5 degrees celsius, product meets pyrogen requirements

54
Q

explain the endotoxin test

A

uses the blood cells of a horseshoe crab. (limulus polyphemus)

contains an enzyme that clots in the low presence of LPS

55
Q

preparing the formulation of a parenteral product includes selecting what?

A

proper solvents/vehicles and additives

56
Q

when preparing parenteral products, what important factors should be practiced

A

must be sterile and pyrogen free

57
Q

why are some injections packaged as dry solids rather than in conjunction with a solvent?

how should these dry solids be sterilized?

A

because the therapeutic agent is unstable in the presence of the liquid component

should be sterilized through DRY HEAT or another appropriate method

58
Q

explain the packaging of Mix-O-Vial

A

has dry ingredients in the bottom compartment and a liquid diluent at the top, separated by a seal.

59
Q

explain how ADD-vantage works

A

2 components – flexible plastic container with diluent, and a glass vial with the medication and “piggybacks”

drug is release by removing the stopper between the 2 , allowing them to mix.

this preserves the closed, sterile system

60
Q

name the 2 types of dosing containers for parenteral solutions

A

single-dose containers
multi-dose containers

61
Q

name 3 types of packaging for parenteral solutions

A

ampuls
vials
pre-filled syringes

62
Q

what is the oldest type of parenteral product container? what is it made of?

A

ampuls – made entirely of glass

63
Q

are ampuls intended for single or multi dose use? how are they opened?

A

single use ONLY
opened by breaking the glass at a line on the neck

64
Q

how are ampuls sealed?

A

by the fusion of the glass container under aseptic condition

65
Q

for which dosing container does the product have to be FILTERED before administration? why?

A

ampuls
this is because in order to open it you have to break the glass at a line on the neck, so glass particles may be in there

66
Q

give the definition of a parenteral vial

A

a glass/plastic container that is closed with a rubber stopper and sealed with an aluminum crimp

67
Q

name 3 advantages of VIALS over ampuls

A

-is a multi-dose container with a bacteriostatic agent

-easier to remove the product

-this easy open eliminates the risk of glass particle contamination during opening

68
Q

name 2 disadvantages of vials

A

-multiple withdrawals can result in microbial contamination

-rubber stopper can become “cored” by the needle

69
Q

classify the glass containers used for parenteral vials

A

Type I - borosilicate
Type II - soda-lime treated glass
Type III - soda lime glass

70
Q

explain Type I glass container

A

made of borosilicate

it is chemical resistant and has low thermal coefficient of expansion (doesnt expand a lot when exposed to heat)

71
Q

Explain Type II glass container

A

soda-lime treated glass

has a lower concentration of migratory oxides than type III

is treated with sulfur ocide to dealkalize the internal surface (make more acidic)

used for solutions with pH less than 7

72
Q

explain what Type III glass containers are good for

A

soda-lime glass

good for anhydrous (no water) liquids or for dry substances

73
Q

name 2 types of plastic polymers that are potentially used for plastic containers

differentiate them

A

PVC (polyvinylchloride) and polyolefin

PVC = flexible and non rigid
polyolefin = semi-rigid, but can be stored upright

74
Q

name 4 advantages of plastic containers over glass

A

unbreakable
easier to store
weighs less
improved safety

75
Q

pre-filled syringes and cartridges are designed for _____ and are administered when?

A

designed for maximum convenience and administered in an EMERGENCY

76
Q

Give 2 examples of drugs that are pre-filled and available for immediate injection

A

atropine and epinephrine

77
Q

explain how pre-filled syringes/cartridges have improved accuracy

A

the medication is premixed and premeasured. has the needle already attached to the prefilled medication cartridge

78
Q

____ are ready-to-use parenteral packages

A

tubex

79
Q

tubex consists of a ___or ___ cartridge holder

A

metal or plastci

80
Q

infusion solutions are used for….

A

the intermittent or continuous infusion of fluids or drugs

81
Q

differentiate between small volume parenterals (SVP) and large volume parenterals (LVP)

A

small volume = less than 100mL
large volume = 100 mL or greater

82
Q

true or false

parenteral products are overfilled somewhat

A

true

83
Q

which are overfilled more – mobile liquids or viscous liquids?

A

viscous

84
Q

Laminar flow hoods have what kind of filters?

A

HEPA filters
(high-efficiency particulate air filters)

85
Q

what does federal class 100 mean

A

related to air quality (in this case in laminar flow hood)

no more than 100 particles sized 0.5 micrometers or larger per cubic foot of air

86
Q

name the 2 types of laminar flow hoods

A

vertical and horizontal

87
Q

explain the purpose of vertical laminar flow hoods vs horizontal

A

vertical – prevents the materials from being blown at you. like toxic things and chemoreactants

horizontal – air flows to you

88
Q

name the 7 requirements for the labeling of injections

A

-name of the preparation

-for a LIQUID, % content of the drug or the amount of drug in a specified volume

-for DRY preparation, the amount of active ingredient present and the volume of liquid to be added to prepare the solution/suspension

-the ROUTE of administration

-statement of STORAGE CONDITIONS and EXPIRY DATE

-name of manufacturer and distributor

-identifying lot number that can yield complete manufacturing history of the specific package, including all manufacturing, sterilizing, and labeling operations

89
Q

when is the expiry date of a drug?

A

when the API is at less than 90% potency

90
Q
A

Pharmaceutics FINAL (8 decks)

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