DrSayed Abbas NMT 244 Lecture 9 99mTc 99mTc is used in 80 of NM procedures 25 million procedures per annum in world 99Mo 99mTc generator 99Mo has half life 67hrs 99mTc half life 6 hrs ID: 705845
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Slide1
Radiopharmaceuticals and Kit preparation
Dr.Sayed
Abbas.
NMT 244
Lecture 9Slide2
99mTc99mTc
is used in 80% of NM procedures
25 million
procedures per annum in world
99Mo/ 99mTc generator
99Mo has half life 67hrs
99mTc half life 6 hrs
99Tc has half life of 211000 years
235U by fission to 99Mo (6%)yieldSlide3
99m
Tc produced from the decay of
99
Mo
99Mo produced by fission of 235U
Production
Fission of
235
USlide4
1st
generation radiopharmaceuticals
99mTc MDP (
Methyle
Di Phosphonate) 99mTc DTPA(Di-ethylene,Tri-amine,Penta-Acetic Acid)braine examinations. 2nd generation radiopharmaceuticals99mTc MIBI99mTc MAG3 (RBC used to any exam related to blood)3rd
generation radiopharmacticals99mTc Hynic 111 In CEASlide5
Cold Kitsnon-radioactive unit-dosed reagent kits [cold unit doses (CUDs)] as an efficient and cost-saving method for
99m
Tc radiopharmaceutical preparation
A
cold kit contains the Ligand to which 99mTc is to be complexed (organ specific)Reducing agent , Sn(II)-chloridBuffer to adjust the pH
for labeling (NaOH/ HCl)Stabilizing agents(ascorbic acid) Excipients for isotonicity (NaCl) The kits are prepared in a freeze-dried form and have a long shelf life, ranging from several months to years. Storage in a refrigerator at 2–8°C is advantageousSlide6
Ideal Diagnostic Radioisotope:
Easy Availability:
Readily Available,
Easily Produced Inexpensive:
Target to Non target Ratio: It should be high to: Pure gamma emmitter maximize the efficacy of diagnosis minimize the radiation dose to the patientEffective Half-life:– Short enough to minimize Radiation expo Long enough to perform the procedure. Ideally 1.5 times like 99mTc MDPSlide7
Ideal Diagnostic Radioisotope:
Example:
For a Bone Scan which is a 4-h procedure, 99mTc- phosphate compounds with an effective half-life of 6 h are the ideal radiopharmaceuticals
Patient Safety
:
Should exhibit no toxicity to the patient.Preparation and Quality Control: Should be simple with little manipulation. No complicated equipment No time consuming stepsSlide8
Radio pharmacy Kit prepSlide9
Preparation of Radiopharmaceutical
1- Sterilization:
-
Radiopharmaceutical preparations intended for parenteral administration are sterilized by a suitable method.
Terminal sterilization by autoclaving is recommended for heat stable productsFor heat labile products, the
filteration method is recommended.2- Addition of antimicrobial preservatives:Radiopharmaceutical injections are commonly supplied in multidose containers.Slide10
Radiation shielding:
Adequate shielding must be used to protect laboratory personnel from ionizing radiation.Slide11
Pro-Tec II Syringe Shield
Guard Lock PET Syringe Shield
Color Coded Vial Shields
Pro-Tec V Syringe ShieldSlide12
Vial Shield
Unit Dose Pig
High Density Lead Glass Vial Shield
Sharps Container ShieldsSlide13
Radiation shielding:
Alpha particles
are mono-energetic and have a range of a few
centimetres
in air.aluminium, glass, or transparent plastic materials, are used to shield sources of beta radiation.Gamma radiation is commonly shielded with lead and tungsten.Slide14
Radiopharmaceutical quality control:
Visual Inspection of Product
Visual inspection of the compounded radiopharmaceutical shall be conducted to ensure the absence of foreign matter and also to establish product identity by confirming that
a liquid product is a solution, a colloid, or a suspension
a solid product has defined properties that identify it.Assessment of Radioactivity The amount of radioactivity in each compounded radiopharmaceutical should be verified and documented prior to dispensing, using a proper standardized
radionuclide (dose) calibrator.Slide15
Radiopharmaceutical quality control:
Radionuclidic
Purity
The gamma-ray spectrum
Radiochemical purityRadiochemical purity is assessed by a variety of analytical techniques such as:liquid chromatography paper chromatography
thin-layer chromatography electrophoresisSlide16
Radiopharmaceutical quality control:
Particle Size and Number
pH
S
terility test and Bacterial Endotoxin TestingSlide17
Radiopharmaceutical quality control:
Labelling
The label on the outer package should include:
Astatement
that the product is radioactive or the international symbol for radioactivity.
The name of the radiopharmaceutical preparation;The preparation is for diagnostic or for therapeutic use the route of administration;The total radioactivity present (for example, in MBq per ml of the solution) the expiry date the batch (lot) number For solutions, the total volume;Any special storage requirements with respect to temperature and light;The name and concentration of any added microbial preservativeSlide18
Application of radiopharmaceuticals:
1- Treatment of disease:
(therapeutic radiopharmaceuticals)
They are radiolabeled molecules designed to deliver therapeutic doses of ionizing radiation to specific diseased sites.
Chromic phosphate P32 for lung, ovarian, uterine, and
prostate cancersSodium iodide I 131 for thyroid cancerSamarium Sm 153 for cancerous bone tissueSodium phosphate P 32 for cancerous bone tissue and other types of cancersStrontium chloride Sr 89 for cancerous bone tissueSlide19
2- As an aid in the diagnosis of disease (diagnostic radiopharmaceuticals)
The radiopharmaceutical accumulated in an organ of interest emit gamma radiation which are used for imaging of the organs with the help of an external imaging device called gamma camera.
- Radiopharmaceuticals used in tracer techniques for measuring physiological parameters
(e.g.
51 Cr-EDTA for measuring glomerular filtration rate).Radiopharmaceuticals for diagnostic imaging
(e.g.99m TC-methylene diphosphonate (MDP) used in bone scanning).Application of radiopharmaceuticals:Slide20
TaskProperties of Ideal radioisotope for imaging
Cold Kit Contents
QC of Radiopharmaceutical KitSlide21
Thank you