WHAT IS A RADIOPHARMACEUTICAL?

Radioactive product fulfilling all pharmaceutical requirements and intended for in vivo administration in humans with special purpose to carry out diagnostic or therapeutic procedure

REQUIREMENTS TO BE MET BY RADIOPHARMACEUTICALS

• All necessary requirements concerning the protection from the ionizing radiation
• Requirements aimed at the safety and efficacy of drugs

CARRIER + RADIONUCLIDE

Carrier: provides for the affinity to a special body tissue

Radionuclide: intended to the purpose of detection only (diagnostics) or interaction with the tissue (therapeutics)

Example of a diagnostic radiopharmaceutical

¹²³I - hippurate: thanks to its elimination from the body via renal tubular excretion, it is accumulated in kidneys, therefore the function of kidneys may be monitored and the kidneys may be visualised

Example of a therapeutic radiopharmaceutical

¹³¹I - sodium iodide: copies the natural metabolism of I" ions and accumulates in the thyroid gland; thanks to heavy accumulation in the target tissue and high LET of the beta particles in the tissue, the hyperplasia or cancer cells of the thyroid gland may be destroyed

SOURCES OF RADIONUCLIDES

• Naturally occurring radionuclides

• Radionuclides produced by reactor:

- by irradiation

- products of uranium fission

• Radionuclides produced by cyclotron

• Generator radionuclides

SPECIAL CONDITIONS FOR PRODUCTION OF RADIOACTIVE DRUGS

• Special areas under closure, fulfilling the demands for work with radionuclides and drug production

• Special equipment

• Special procedures

• Specially trained team

SPECIAL AREAS FOR RADIOPHARMACEUTICAL PRODUCTION

• Hot / semihot cells with cleanable surface, manipulators
• Air-conditioning, filtration

SPECIAL EQUIPMENT

• Remote control
• Vacuum transport of liquid media
• High demands put on the electronic equipment and valves

• Disinfection, cleaning and maintenance
• Sterilization
• Aseptic work

EXAMPLES OF IODINE RADIOPHARMACEUTICALS
 

131 I - Iortho-iodo-hippurate	Diagnostics — isotope nephrography, renal scintigraphy
131 I - meta-iodo-benzylguanidine	Therapy - feochromocytoma, neuroblastoma
125 I - ortho-iodo-hippurate	Diagnostics - isotope nephrography of children
125 I - labelled compounds for RIA	In vitro diagnostics
123 I - meta-iodo-benzylguanidine	Diagnostics - feochromocytoma, neuroblastoma
124 I - ?	Theoretical possibility of PET-examination of various tissues (so far not used with this radionuclide)

THE IMPORTANCE OF TECHNEGIUM ^99mTc IN NUCLEAR MEDICINE

• An estimate: 80% of all examinations carried out in nuclear medicine
• Favourable properties (T_1/2 = 6 h, Eg = 140 keV)
• Production of generators
• Utilization of so-called kits, labelling on the site

QUALITY ASSURANCE AND QUALITY CONTROL OF RADIOPHARMACEUTICALS

Quality assurance: Good Manufacturing Practice + Quality Control

Identity check :- half-life measurement

• Manufacturing schedule
• Packaging
• Documentation
• Transport
• Delivery
• Feedback

EXAMPLE OF MANUFACTURING SCHEDULE - ⁸¹Rb/^81mKr generators
 

Monday & Thursday morning	Preparation of the target & documentation Order deadline
5,30 -7,30 p.m.	Irradiation
7,45 - 8,30 p.m.	Target processing, production of 81Rb
8,30-10,30 p.m.	Production of generators
10,30 p.m. - 0,30 a.m.	Quality control
0,30-2,30 a.m.	Packaging of generators
4,45 a.m.	Transport to the customers
Tuesday, Friday 8,00 a.m.	Use of the generators in hospitals

ASPECTS OF PRODUCTION OF CYCLOTRON RADIOPHARMACEUTICALS

• Target technique

• Technology of radionuclide production

• Carrier labelling

• Special conditions of the production

• Aspects of quality control

• Logistics