Radiopharmaceuticals and Kit preparation Dr.Sayed 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 99Tc has half life of 211000 years 235U by fission to 99Mo (6%)yield

99mTc produced from the decay of 99Mo 99Mo produced by fission of 235U Production 99mTc produced from the decay of 99Mo 99Mo produced by fission of 235U Fission of 235U

1st generation radiopharmaceuticals 99mTc MDP (Methyle Di Phosphonate) 99mTc DTPA(Di-ethylene,Tri-amine,Penta-Acetic Acid)braine examinations. 2nd generation radiopharmaceuticals 99mTc MIBI 99mTc MAG3 (RBC used to any exam related to blood) 3rdgeneration radiopharmacticals 99mTc Hynic 111 In CEA

Cold Kits non-radioactive unit-dosed reagent kits [cold unit doses (CUDs)] as an efficient and cost-saving method for99mTc radiopharmaceutical preparation A cold kit contains the Ligand to which 99mTc is to be complexed (organ specific) Reducing agent , Sn(II)-chlorid Buffer 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 advantageous Ligand : attached to Buffer : stop / Excipients : serves as the vehicle or medium for a drug or other active substanceوسيلة او وسيطisotonicityتساوي التواتر

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 patient Effective Half-life: – Short enough to minimize Radiation expo Long enough to perform the procedure. Ideally 1.5 times like 99mTc MDP

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 steps consuming : استهلاك

Radio pharmacy Kit prep

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 products For heat labile products, the filteration method is recommended. 2- Addition of antimicrobial preservatives: Radiopharmaceutical injections are commonly supplied in multidose containers. parenteral :بالحقن preservatives : المواد الحافظة

Radiation shielding: Adequate shielding must be used to protect laboratory personnel from ionizing radiation.

Pro-Tec II Syringe Shield Guard Lock PET Syringe Shield Pro-Tec V Syringe Shield Color Coded Vial Shields

Vial Shield Unit Dose Pig High Density Lead Glass Vial Shield Sharps Container Shields

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. mono-energetic : أحادي الطاقة

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. Colloid :gels,emulsions,gum مادة غروانية

Radiopharmaceutical quality control: Radionuclidic Purity The gamma-ray spectrum Radiochemical purity Radiochemical purity is assessed by a variety of analytical techniques such as: liquid chromatography paper chromatography thin-layer chromatography electrophoresis chromatography :اللوني electrophoresis :الكهربائي

Radiopharmaceutical quality control: Particle Size and Number pH Sterility test and Bacterial Endotoxin Testing

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 preservative

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 cancers Sodium iodide I 131 for thyroid cancer Samarium Sm 153 for cancerous bone tissue Sodium phosphate P 32 for cancerous bone tissue and other types of cancers Strontium chloride Sr 89 for cancerous bone tissue

Application of radiopharmaceuticals: 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). tracer techniques : تقنيات التتبع

Task Properties of Ideal radioisotope for imaging Cold Kit Contents QC of Radiopharmaceutical Kit

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