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Pharmaceutics Year 2 > Section 7 - Parenterals 1 > Flashcards

Section 7 - Parenterals 1 Flashcards

1
Q

What does parenteral mean?

A
  • Administration by injection

- Main routes are subcutaneous, intramuscular, and intravenous

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2
Q

What are the advantages to parenterals?

A
  • Rapid onset of action
  • Complete and predictable bioavailability
  • Avoidance of GI tract
  • Reliable route for comatose, very ill, and uncooperative patients (who are experiencing preventable side effects)
  • Allows high dose medication
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3
Q

What are disadvantages to parenterals?

A
  • Frequent dosing
  • Pain
  • Cost
  • Medications errors difficult or impossible to reverse
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4
Q

Which drugs is a parenteral route useful for?

A

Drugs showing unreliable GI absorption, inactivation or destruction by GI tract (extensive first-pass or mucosal metabolism)

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5
Q

Which patients is a parenteral route useful for?

A

Patients that require rapid, assured high blood levels or constant blood levels

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6
Q

Which health care professional has the greatest amount of information regarding parenteral products?

A

Pharmacists

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7
Q

What is a syringe?

A

A device for measuring injectable products

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8
Q

What can a syringe be made of? What does it consist of? What are the sizes of syringes?

A
  • Can be made of glass or plastic
  • Consists of barrel and plunger
  • Range from 1-60 mL
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9
Q

What should a syringe be made of if the drug is to be stored in syringe for a protracted period of time?

A

Glass

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10
Q

Why are disposable syringes almost always used?

A
  • Cost

- Danger of cross-contamination w/ AIDS or hepatitis

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11
Q

What are needles made of?

A

Stainless steel

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12
Q

As the gauge of a needle increases, what happens to diameter?

A

Decreases

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13
Q

What determines the selection of needle gauge and length?

A
  • Site of administration

- Nature of product being injected

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14
Q

What are the 2 variations of needles?

A

1) Butterfly for pediatrics

2) Teflon or silastic cannulas for long-term use

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15
Q

What does a basic IV administration set consist of?

A
  • Spike
  • Drip chamber
  • Tubing
  • Roller clamp
  • End fitting compatible w/ hub of a needle or cannula
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16
Q

When is a vented IV administration set needed? When is a non-vented set needed?

A
  • Vented = rigid glass bottles

- Non-vented = flexible plastic bags

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17
Q

What is the function of a spike?

A

To allow entry into the closure of the container

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18
Q

What is the function of a drip chamber?

A

To allow the flow rate to be set

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19
Q

What is the function of a roller clamp?

A

To allow the flow rate to be adjusted

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20
Q

Why are filters sometimes attached to the end of the IV administration set?

A
  • To protect the patient from particulate material

- Some sets (Buretrol) are specifically designed for drug administration

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21
Q

When is the subcutaneous route used?

A
  • Vaccines
  • Insulin
  • Scopolamine
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22
Q

What is the max volume for a subcutaneous injection?

A

2 mL

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23
Q

What are the typical body sites of subcutaneous injections?

A

Arms, legs, abdomen

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24
Q

What should be done if ongoing injections are needed?

A

Rotate sites

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25
Q

Does IV or IM have a faster onset?

A

IV

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26
Q

Intramuscular injections are injected into _____

A

Striated muscle fibers

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27
Q

What are the usual sites of intramuscular injections?

A

Deltoid, lateral or gluteal muscles

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28
Q

What is the usual volume of intramuscular injections?

A

1-3 mL (use multiple sites if greater than 5 mL)

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29
Q

What does the release rate of an intramuscular injection depend on?

A
  • Vascularization
  • Formulation
  • Drug solubility in water
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30
Q

What are advantages to IV administration?

A
  • Direct into lumen of vein
  • Extremely rapid predictable response
  • Avoids tissue irritation and GI tract
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31
Q

What is a disadvantage to IV administration?

A

Difficult or impossible to reverse if error occurs

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32
Q

What is the normal volume and rate of IV injections?

A
  • Volume = 1-100 mL

- rate = 1 mL/10-20 seconds

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33
Q

When are volumes larger than 100 mL administered by IV?

A

Fluid and electrolyte replacement

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34
Q

What is an intrathecal administration?

A

Drug administered directly into CSF

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35
Q

What characteristics are needed of the drug to be administered intrathecally?

A

High purity, preservative-free, and free of particles

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36
Q

Which drugs should never be given intrathecally and why?

A
  • Antineoplastic vincristine

- This route bypasses the BBB

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37
Q

Are intrathecal and epidural administrations the same?

A

No, intrathecal is administered into CSF and epidural is injected outside the dural membrane w/in the boney spinal caudal canals

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38
Q

Intra-ocular products must be of similar quality to ____

A

Intrathecal

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39
Q

Death of cells often appear to follow ____ order process

A

First

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40
Q

What does it mean when cell death follows a first order process?

A

The time interval required to bring about one decimal reduction (90% reduction) is constant

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41
Q

How is sterility determined?

A

Sterility testing of entire batch

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42
Q

What is sterility assurance level (SAL) expressed as and what does this mean?

A
  • Expressed as log10 probability of survival

- SAL of 6 means 1 in 1,000,000 units contaminated

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43
Q

What is an acceptable SAL value for critical items?

A

6 (1 in 1,000,000)

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44
Q

How is a SAL of 6 achieved?

A

Apply process to reach log (10^0) then safety factor to deliver extra 6 log reduction

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45
Q

What is the D-value?

A
  • Decimal reduction time

- Time for population to decrease by 1 log unit

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46
Q

When do you need to state temperature for D-value?

A

When heat sterilization processes are used

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47
Q

What is a Z-factor?

A
  • Temperature increase needed to provide a decimal reduction time
  • Generally as temp increases, need shorter exposure times
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48
Q

What does it mean if a D-value is 20 and a Z-factor is 9?

A

Every increase of 9 degrees will decrease the D-value by 10 fold (from 20 minutes, to 2 minutes, to 0.2 minutes…)

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49
Q

What could make a plot of loq survivors NOT be linear?

A
  • Cells clumping
  • Mutations more resistant to process
  • Populations of mixed species
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50
Q

Which processes tend to display a non-linear plot of log survivors?

A

Chemical processes

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51
Q

What are some sources of microbial contamination?

A
  • Atmosphere
  • Water
  • Raw materials
  • Packaging
  • People
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52
Q

Which species are likely to cause microbial contamination through water?

A

Pseudomonas

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53
Q

Which species are likely to cause microbial contamination through packaging?

A

Mold spores from paper

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54
Q

How many microorganisms can a person shed per hour?

A

10-100 cfu, even when properly gowned

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55
Q

What are the 5 methods of sterilization recognized by the USP?

A
  • Steam
  • Dry heat
  • Filtration
  • Gas
  • Ionizing radiation
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56
Q

What determines which method of sterilization should be used?

A
  • Nature of product

- Expected bioburden

57
Q

What is the bioburden for kaolin and which method of sterilization should be used?

A
  • Potentially high

- Dry heat

58
Q

Which sterilization method should NOT be used for petrolatum and why?

A

Steam penetration b/c will not penetrate these materials (petrolatum or oil)

59
Q

What is the definition of sterilization?

A

Inactivation or removal of all viable microorganisms

60
Q

Define disinfectant

A

Substance used on inanimate objects to render them non-infectious

61
Q

Define antiseptic

A

Substance used on animate objects to kill microorganisms or prevent them from multiplying

62
Q

Define bacteriostatic

A

Substance which prevents multiplication of microorganisms; often used as preservatives

63
Q

Define terminal sterilization

A

Process where sterilization is the final procedure

64
Q

What must be characteristics of the product and container for steam sterilization?

A
  • Product and container not damaged or altered by heat

- Container must be permeable to steam

65
Q

Are pyrogens affected by steam?

A

No

66
Q

What is the normal temperature and pressure of an autoclave?

A

121 C and 15 psi(g)

67
Q

What occurs in an autoclave?

A
  • Steam enters from top and displaces air from bottom through traps and valves (gravity displacement)
  • Large systems may use a vacuum pump to remove air
68
Q

Are dry steam or air-steam mixtures more efficient?

A

Dry steam

69
Q

What must be considered w/ respect to temperature if liquid material is in an autoclave?

A

Must allow time for contents to reach 121 C before starting timing

70
Q

How long is an autoclave normally run?

A

15-20 minutes

71
Q

What must be done if a sealed aqueous product is in an autoclave?

A

Must allow to cool w/ autoclave sealed, otherwise pressure in the container will cause an explosion

72
Q

What is the method of kill w/ steam sterilization?

A

Hydrolysis and protein and nucleic acid coagulation and denaturation

73
Q

What must steam do to kill microorganisms?

A

Come into direct contact w/ microbial cells and release latent energy

74
Q

What is dry heat used for?

A
  • Containers and equipment

- Oil and lipid material (as long as not adversely affected by heat)

75
Q

Is dry heat or steam more efficient, and what does this mean?

A

Steam, so dry heat requires longer times

76
Q

Which method is used for destruction of pyrogens and for how long at what temperature?

A
  • Dry heat

- 250 C for 30 minutes

77
Q

What is the usual temperature and run time of dry heat?

A

160 C for 2 hours

78
Q

What is the mechanism of kill for dry heat?

A

Oxidation

79
Q

Which gas is used for sterilization and where is it used?

A
  • Ethylene oxide

- Hospitals for plastic devices and some powdered drugs

80
Q

What is ethylene oxide mixed with and why?

A

Mixed w/ CO2 or a fluorocarbon to overcome flammability and explosive nature of ethylene oxide

81
Q

Which parameters are important for gas sterilization?

A
  • Gas concentration
  • Temperature
  • Humidity
  • Exposure time
82
Q

What is the usual exposure time for gas sterilization?

A

1.5 hours

83
Q

What must be done when performing gas sterilization?

A

Allow venting to allow residual gas to dissipate

84
Q

What is the mechanism of kill of gas sterilization?

A

Alkylation of various reactive groups in bacterial cells and spores

85
Q

What is the sterilant of choice for isolators?

A

Vapor phase hydrogen peroxide

86
Q

What temperature does vapor pressure hydrogen peroxide sterilization occur at?

A

Room temperature

87
Q

What is the normal exposure time for vapor phase hydrogen peroxide sterilization?

A

90 minutes (fairly fast acting)

88
Q

What is the method of kill of vapor phase hydrogen peroxide sterilization?

A

Oxidation

89
Q

What are the 2 types of filter medium?

A

Depth and membrane

90
Q

What is membrane filter medium used for?

A

Sterilization

91
Q

What is the pore size of membrane filter medium?

A

0.2 um

92
Q

Does filtration remove pyrogens?

A

No

93
Q

What are the various types of membranes and what are they used for?

A
  • Hydrophilic for aqueous
  • Hydrophobic for non-aqueous
  • Low protein binding
94
Q

Why is selection of a membrane important?

A
  • To avoid dissolution of filter components into product
  • Avoid loss of product due to binding of drug to membrane
  • Bubble-point for integrity testing
95
Q

What is ionizing radiation used for?

A

Disposable plastic materials and powdered drugs

96
Q

What must be validated w/ ionizing radiation?

A
  • Radiation dose and exposure time

- Establish that penetration of the product has been achieved and that the product is not altered by exposure

97
Q

What is a disadvantage of ionizing radiation?

A

Expensive and only practical for large production runs

98
Q

What is the method of kill of ionizing radiation?

A

Damage to nucleic acids, making them non-functional

99
Q

What are 2 disadvantages to the use of UV radiation?

A
  • Penetration

- Energy levels often not high enough to be effective

100
Q

What does validation involve?

A

Making sure equipment meets required performance specifications and that personnel have understanding of process and equipment

101
Q

What are some simple things that can be done for validation?

A
  • Placement of thermocouples at different locations in the load
  • Maintaining temperature-time records for each batch
  • Using temp indicators (autoclave tape, chemical indicator tape) for EtO sterilization
  • Check membrane filters for integrity by resistance to air passage while wet
  • Perform sterile fills
  • Monitor environment for bioburden by use of settle-plates and Rodac plates
102
Q

What is the purpose of sterility testing?

A

Determine the probable sterility of a specific batch of product

103
Q

What are the 2 basic method of sterility testing?

A
  • Direct inoculation of test material into culture medium

- Membrane filtration of test material followed by incubation of membrane in suitable media

104
Q

Which method of sterility testing is more accurate and why?

A

Membrane filtration b/c has contact w/ all solvent in the media, so any microorganisms will reach the membrane and culturing it will provide an indication of contamination, whereas direct inoculation is only culturing a small portion of the solvent

105
Q

Does sterility testing provide a guarantee that the entire batch is sterile?

A

No

106
Q

What is a negative control used for?

A

To ensure media is sterile

107
Q

What is a positive control used for?

A

To ensure the media can support growth of organisms

108
Q

What occurs in a main positive control?

A

Test material is inoculated w/ organism to ensure the product doesn’t adversely affect the test organisms, then the test preparation is run alone

109
Q

What does USP chapter 71 define?

A

Growth media required, rinsing and diluting fluids, test organisms, and general procedure for sterility testing

110
Q

When is the membrane technique of sterility testing more useful?

A
  • Product has bacteriostatic or bactericidal

- Drug is in oil vehicle or ointment dose form

111
Q

On which days should a sterility test be read and why?

A
  • Days 3, 7, and 14

- Moulds require 14 days to grow

112
Q

When are the requirements of a sterility test met?

A

If no growth in the test units and growth in appropriate controls

113
Q

When should a sterility test be repeated?

A

If growth in test units, but evidence that it may be from deviation from procedure

114
Q

When should a sterility test be repeated and the number of samples doubled?

A

If growth occurs and no documentation of procedural deviation

115
Q

What is the minimum number of articles to be tested for parenterals less than 100 units?

A

10% or 4 units, whichever is greater

116
Q

What is the minimum number of articles to be tested for parenterals between 100 and 500 units?

A

10 units

117
Q

What is the minimum number of articles to be tested for parenterals above 500 units?

A

2% or 20 units, whichever is less

118
Q

What is the minimum number of articles to be tested for large volume parenterals?

A

2% or 10 units, whichever is less

119
Q

What is the minimum number of articles to be tested for ophthalmic preparations less than 200 units?

A

5% or 2 units, whichever is greater

120
Q

What is the minimum number of articles to be tested for ophthalmic preparations more than 200 units?

A

10 units

121
Q

For sterility testing, quantity of product should not exceed __% of the medium volume

A

10

122
Q

What is luciferin-luciferase testing used for?

A

Water

123
Q

What is the radiocarbon technique used for?

A

Blood culture

124
Q

What are pyrogens?

A

Lipopolysaccharide components of microorganisms w/ function as endotoxins

125
Q

Are pyrogens living?

A

No

126
Q

Which pyrogens are usually most potent?

A

Those produced by gram-negative organisms

127
Q

What do small doses of pyrogens cause?

A

Fever, leukopenia

128
Q

What do large doses of pyrogens cause?

A

Shock and death

129
Q

What do pyrogens do once in the body?

A

Provoke an intense immune response by producing endogenous substances like prostaglandins, proinflammatory cytokines interleukin-1, interleukin-6, and TNF-alpha

130
Q

How can you avoid pyrogen contamination?

A

Ensure non are present in starting materials, especially water

131
Q

What is the most common source of pyrogen contamination?

A

Water

132
Q

What are some general methods of removing pyrogens?

A

Dry heat, oxidizing agents, adsorption, and ultrafiltration

133
Q

How can pyrogens be removed from water?

A

Distillation

134
Q

When are requirements met for the USP 151 test for pyrogens and what is done if the requirements aren’t met?

A
  • When none of the 3 rabbits have an individual temp rise over 0.6 C, and the total temp rise of the 3 rabbits is not above 1.4 C
  • If not met, 5 additional rabbits are tested
135
Q

What occurs in the Limulus Amoebocyte Lysate test?

A
  • Amebocytes from blood cells of Horseshoe crabs are lysed to release a protein that reacts w/ pyrogens
  • The product will form a gel, which proves pyrogens are present
136
Q

When in the Limulus Amoebocyte Lysate test used?

A
  • Testing water for injection

- Testing short-lived radioisotopes in nuclear medicine

137
Q

What is important to note about the Limulus Amoebocyte Lysate test?

A

Only tests for gram-negative bacterial endotoxins

138
Q

What is particulate matter?

A

Extraneous, undissolved substances unintentionally present in parenteral solutions

139
Q

Are particulates harmful to injections?

A

Not clear, but detracts from product elegance which reduces confidence in product and manufacturer

Pharmaceutics Year 2 (17 decks)

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