Radiopharmaceuticals and Kit preparation - PowerPoint Presentation

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