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NucPharma Lec > Technetium-99m Labelled Kit Preparation > Flashcards

Technetium-99m Labelled Kit Preparation Flashcards

1
Q

Non-radioactive pharmaceutical products that are intended for radiolabeling

A

cold kits

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2
Q

intended for direct radiolabeling

A

cold kits

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3
Q

Direct incorporation of the metal to the chelator causing it to become a fully functional diagnostic or therapeutic radiopharmaceutical

A

end product of cold kits

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4
Q

add the radionuclide to the vial and mix it in the presence/absence of heat for a long/short period of time

A

direct radiolabeling

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5
Q

General components of Tc99m cold kits

A
  • Ligand / complexing agent / chelating agent
  • Reducing agent/s
  • Antioxidant/s
  • Catalyst/s
  • pH adjusters (single pH adjusting agent or pH buffer systems)
  • Tonicity adjusters
  • Fillers
  • Blanketing / purging agent
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6
Q

Acts as the chelator for the metal present in the other solution, which is the eluate of the generator (general purpose)

A

Ligand

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7
Q

reduce the oxidation state of technetium (from +7 to +5, +4 or +3) for it to be more favorable that will participate in the reaction

A

reducing agents

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8
Q

prevent the oxidation and scavenge the free radicals

A

antioxidants

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9
Q

speed up the formation of the complex (without this it will be slow or not working at all)

A

catalyst

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10
Q

involved in causing the formation of the Tc-Sn colloid and TcO2

A

pH adjusters

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11
Q

adjust the concentration of the salt solution to be compatible with our bodily fluids

A

Tonicity adjusters

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12
Q

also called as bulking agents

A

Fillers

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13
Q

facilitate the solution and will not clump together but will be dispersed across the matrix of the filler

A

Fillers

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14
Q

remove the oxygen present in the vial because the oxygen oxidizes or speed up the formation of stannic ion which are not desirable because it will reduce the efficacy of the stannous ion in producing the pertechnetate

A

Blanketing

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15
Q

gases nitrogen and argon

A

inert gases

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16
Q

it cannot introduce air because you would want to remove the oxygen present in the vial. Therefore, you need to completely eliminate the presence of oxygen. You need to replace it with a denser gas such as argon or nitrogen gas

A

Blanketing

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17
Q

▪ Effective reduction at mild conditions (neutral to weakly acidic
conditions, absence of toxic substances, labeling at room
temperature)
▪ Formation of a single component complex with a distinct
oxidation state
▪ No interference with the complexation process
▪ Not included in the final complex
▪ Stable during storage of the kit (long shelf life)

A

Ideal Reducing agent:

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18
Q

it reduces the oxidation state to a more favorable one that will participate in the complexation reaction

A

Reducing agents

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19
Q

what is the normal working range of Tc radiolabeling

A

5-7

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20
Q

why is pH 6 is better?

A

because at pH 7, the rate of hydrolysis increases. you need to reduce the pH to more acidic than neutral

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21
Q

what oxidation state does Tc exist in formation of a single component complex with a distinct oxidation state

A

-1 to +7

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22
Q

normal oxidation state of Tc

A

+4

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23
Q

can you use another reducing agent that may participate
in the complexation reaction?

A

no

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24
Q

is citrate a reducing agent?

A

no, it only participates in complexation reaction

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25
Q

Stable during storage of the kit (long shelf life)

A

something that is very reactive

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26
Q

for example, you add a metal magnesium. Metal
magnesium is very active when in the presence of air, so when you have a Mg in the presence of air it forms magnesium oxide and then MgO it reduces the amount of metallic Mg. Therefore, the shelf life of magnesium metal decreases because it readily reacts with presence of oxygen in the air

A

Stable during storage of the kit (long shelf life)

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27
Q

what is the most well known Tc99m reducing agents

A

Stannous salts

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28
Q

what is the most used stannous salt?

A

Tin (II) chloride

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29
Q

Stannous salts are (non-toxic toxic) and (unstable or stable) when lyophilized and kept in a nitrogen atmosphere

A

non-toxic and stable

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30
Q

The amount of stannous chloride is empirically optimized for each kit to balance between the two parameters: what are the two

A

a. Completely reducing pertechnetate From Tc (VII) to Tc (IV)
b. Avoid reducing pertechnetate From Tc (VII) to lower oxidation states

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31
Q

what happens if you add more Tc+4?

A

you reduce the radiolabeling efficiency for that kind of radiopharmaceutical

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32
Q

what is the ratio

A

1 million : 1

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33
Q

what certain situations wherein the amount of reacting stannous ion must be controlled

A

a. wherein the metal exists in multiple oxidation states are favored with a certain ligand
b.when hydrolysis products interfere with complex stability

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34
Q

what limits the release of stannous ion into the solution

A

The use of:

Tin (II) tartrate
Tin (II) gluconate
Tin (II) citrate
Tin (II) EDTA etc.

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35
Q

Under certain pH conditions, Stannous chloride is not soluble in water. But in acidic pH, they are soluble or insoluble?

A

soluble

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36
Q

Direct labeling of proteins

A

stannous chloride is administered for “pre-tinning”

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37
Q

incubating the protein with stannous ion, reactive disulfide bonds are reduced in addition to pertechnetate

A

pre-tinning

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38
Q

just deactivate all sites of the protein before you label it with Tc +4

A

pre-tinning

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39
Q

if it is said that it is just based on 370 MBq or 10 mCi, when you have higher activity, what should happen to the Tin content?

A

increase

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40
Q

Issues with using Stannous ion

A
  • Stannous compounds are difficult to purify; they contain at least 5% Sn (IV) →Sn (IV) is an unavoidable, relatively concentrated impurity in radiopharmaceutical preparations
  • Stannous ion is readily oxidized by various oxidants such as oxidant in the air (oxidation proceeds already on standing)
  • The amount of cumulative Tc-99 exceeds the reductive capacity of tin
  • During the reduction of pertechnetate, tin is oxidized and hydrolyzed to highly poly-dispersed colloidal particles (only occurs if there are weak and unsuitable ligands present in 99mTc labeling)
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41
Q

is an unavoidable, relatively concentrated impurity in radiopharmaceutical preparations

A

Sn (IV)

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42
Q

what percentage of Sn (IV) stannous compounds contain?

A

at least 5%

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43
Q

During the reduction of pertechnetate, tin is oxidized and hydrolyzed to ???

A

highly poly-dispersed colloidal particles

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44
Q

Therefore, the addition of tartrate ___ the probability that it will go to completion, as compared to Tc+4 and MAG3 alone

A

increases

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45
Q

In the presence of the tartrate salt: high or low amount of Tc4+ concentration

A

high

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46
Q

In the absence of the tartrate salt: high or low amount of Tc4+ concentration

A

low

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47
Q

Possible ways on how to address issues with Stannous chloride

A
  • Use of other stannous salts such as stannous fluoride, oxalate, tartrate, citrate and phosphates
  • Fixing of stannous ion to an ion exchange resin
48
Q

what are the stannous salts used to address issues with stannous chloride?

A

stannous fluoride, oxalate, tartrate, citrate and phosphates

49
Q

Added to the formulation to increase the stability of the radiopharmaceutical

A

Antioxidants

50
Q

they can serve as scavengers. they scavenge the free radicals formed when the Tc99m interacts with water to form indirect radiolytic product

A

Antioxidants

51
Q

Commonly used Antioxidants in Tc99m radiopharmaceutical kits

A
  • Ascorbic acid
  • Gentisic acid
  • P-aminobenzoic acid
52
Q

Substance that participates in a ligand exchange reactions

A

Catalyst

53
Q

Used when complex formation with a certain ligand is slow relative to formation of reduced hydrolyzed technetium

A

Catalyst

54
Q

Examples of catalysts

A

EDTA
Gluconate
Citrate

55
Q

Another term for Fillers

A

Bulky regions

56
Q

added to achieve rapid solubilization of the vial components through the control of particle size during the lyophilization process

A

Fillers

57
Q

prevent the clumping of certain ingredients because there are certain ingredients that are hard to disperse when clumped together

A

Fillers

58
Q

Examples of Fillers

A

Sodium chloride in HMPAO kits (although sodium chloride is
generally used as a tonicity adjuster)

Mannitol in MIBI kits

59
Q

What is an isotonic solution?

A

0.9 % w/v Na (whatever you will put inside the vial, as long as the total equivalent is 0.9g per 100mL)

60
Q

To ensure that the radiolabeling process will proceed at the right pH

A

pH adjusting agent

61
Q

Single or buffer: Hydrochloric acid and Sodium hydroxide

A

Single pH adjusting agents

62
Q

Single or buffer:
Na3PO4 + Na2HPO4
Citric acid + sodium citrate

A

pH buffers

63
Q

combination of two salts

A

pH buffers

64
Q

dibasic + monobasic phosphate = ???

A

nearly neutral

65
Q

It involves drying of frozen materials by sublimation

A

Lyophilization (freeze drying)

66
Q

Prolongs shelf-life of food and pharmaceutical products

A

Lyophilization (freeze drying)

67
Q

It depends on the storage conditions, leak-proof of the packaging material, and the inherent stability of the cold kit formulation

A

Lyophilization (freeze drying)

68
Q

in cold kits, lyophilization prolongs the shelf life by how many years average?

A

1 year average

69
Q

At 1 atm, it is not possible to sublime ice. Therefore you have to reduce the pressure to _____ for it to be able to participate in the transition between the ice and steam.

A

the vacuum pressure

70
Q

In lyophilization, you need to make the pressure ____

A

at least 0.004 atm

71
Q

The more efficient the sublimation process is, the less water retained in the kit.

A

Therefore, the longer the shelf life of the cold kit.

72
Q

ice to steam

A

sublimation

73
Q

steam to ice

A

deposition

74
Q

to get the 1 year average, it must be stored in how many degrees celsius?

A

2-8 deg celsius

75
Q

In Lyophilization, why is increasing the temp to 30 deg C not be favorable for the cold kit any more?

A

because the higher the temperature the more reactive the ingredients are allowing it to become 2, 3 or 6 months old (shorter shelf life)

76
Q

it ensures that the inert gas will not be exchanging with oxygen in the air, to prevent the cold kit from getting oxidized

A

leak-proofing

77
Q

such as when you have a Stannous fluoride which is inherently unstable in the presence of air, unlike when you add HCl or NaCl. These are not really reacting in the presence of oxygen

A

inherent stability of the cold kit formulation

78
Q

Advantages of lyophilization

A
  • Chemical, bacterial or enzymatic changes do not
    easily occur (prevents souring)
  • Sterility is more guaranteed
  • Transportation is easier
79
Q

Disadvantages of lyophilization

A
  • Reentry of moisture may destroy the products (there is instability)
  • Direct optical control cannot be performed (high tendency to have particulate contaminants)
80
Q

General lyophilization cycle

A

Freezing, primary drying, secondary drying

81
Q

-30 to -80 °C atm, 24-36h

A

Freezing

82
Q

-30 to -80 °C vacuum, 24-36h

A

primary drying

83
Q

15 to 25°C vacuum, 24-36h

A

secondary drying

84
Q

you have to freeze it completely, otherwise, when you have a mixture of ice and water, when you apply vacuum your water will pop out and destroy the product

A

Freezing

85
Q

remove the crystalline ice from the kit

A

Primary drying

86
Q

remove any residual moisture present when you increase the temperature to its intended transport conditions

A

Secondary drying

87
Q

Final process of Lyophilization cycle

A

Purging / backfilling
Stoppering
Crimping

88
Q

15-25°C atm Purged with N2

A

Purging / backfilling

89
Q

Aspect of quality management system that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by their marketing authorization

A

Good manufacturing practices

90
Q

Premises Equipment Production Quality Control
Materials (RM/PM/FP/etc.) Sanitation Complaints
Personnel Documentation Qualification and Validation
Product recall Audits Quality Assurance System

A

Components of good manufacturing practices
(for commercial manufacturers)

91
Q

Raw material quality
Process aid quality

A

Chemical impurities

92
Q

Aseptic conditions
Aseptic techniques

A

Microbiological impurities

93
Q

Manual radiolabeling
Synthesis procedures

A

Radiochemical impurities

94
Q

Reactor and cyclotron production
Generator quality

A

Radionuclidic impurities

95
Q

absence of viable microorganisms

A

Sterility

96
Q

the probability of a single viable microorganism occurring in or on a product after sterilization

A

Sterility assurance level (SAL)

97
Q

Acceptable SAL is ?

A

minimum of 10-6

98
Q

SAL meaning

A

sterility assurance level

99
Q

How do you interpret 10-6 in simple words?

A

For every 1,000,000 sterilized units, 1 unit remains non-sterile

100
Q

the process that destroys or eliminates all viable microorganisms

A

Sterilization

101
Q

3 sterilization methods

A

physical, chemical, radiation

102
Q

what are the physical sterilization methods?

A

steam sterilization
dry heat sterilization
sterile filtration

103
Q

what are the radiation sterilization methods?

A

Ionizing (electron beam, gamma)
Non-ionizing (UV)

104
Q

what are the chemical sterilization methods?

A

Liquid sterilization (alcohols)
Gas sterilization (EtO)

105
Q

ONLY ACCEPTABLE TERMINAL STERILIZATION METHODS

A

steam dry heat, ionizing radiation

106
Q

Removal of microorganisms using a bacterial retentive filter to produce a sterile filtrate

A

Sterile filtration

107
Q

_____ is NOT a terminal sterilization technique

A

Aseptic filtration

108
Q

size of the filter in the COW

A

0.2 um

109
Q

Manufacturing process where all materials including raw materials, equipment, process aids, and packaging materials are first subjected to sterilization separately then processed together in an extremely high quality environment (called a “cleanroom”) that is constantly monitored for air quality and microbial contamination

A

Aseptic processing

110
Q

extremely high quality environment in aseptic processing

A

cleanroom

111
Q

For radiolabeling of Technetium- 99m kits, the diluent used is ???

A

sterile NSS (normal saline solution)

112
Q

WFI may be used IF AND ONLY IF:

A
  • The information on isotonicity of the cold kit is available
  • If specified in the product insert
113
Q

what is WFI

A

water for injection - the purest grade of pharmaceutical bulk water

114
Q

For most common Tc99m radiopharmaceuticals, incubation takes place at ____ temp and _____ incubation time

A

room temperature and there is minimal incubation time

115
Q

Exceptions in incubation

A

those that employ heating which is done under boiling water bath (e.g., [99mTc]sestamibi, [99mTc]MAG3, [99mTc]sulfur colloid)

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