Radiopharmaceuticals are pharmaceutical drugs that contain radioactivity and can be used for diagnostic or therapeutic purposes. They are produced via several methods including charged particle bombardment, neutron bombardment, and using radionuclide generator systems. Their production involves compounding the radioactive component with other reagents followed by sterilization. Their quality is controlled through visual inspection, measuring radioactivity levels, assessing radionuclidic and radiochemical purity, and ensuring sterility. Proper labeling is also required when dispensing radiopharmaceuticals.
2. RADIOPHARMACEUTICALS
• Radiopharmaceuticals
are a group of pharmaceutical
drugs which have radioactivity.
Radiopharmaceuticals can be
used as
diagnostic (Gamma rays)
therapeutic agents (alpha & beta rays).
3.
4. Introduction
All substances are made of atoms
TheY have electrons (e -) around the outside
(naegatively charged) , and nucleus in the middle.
The nucleus consists of protons ( positively charged)
and neutrons (neutral)
The atomic number of an atom is the number of
protons in its nucleus.
The atomic mass is the number of protons +
neutrons in its nucleus.
5.
6. • isotopes of an atom have the same number
of protons,but a different number of
neutrons.
Example
• Consider a carbon atom:
It has 6 protons and 6 neutrons – we call it
carbon – 12” because it has an atomic mass of
12 (6 plus 6).
• One useful isotope of carbon is “ carbon – 14”
which has 6 protons and 8 neutrons.
7.
8. Radioisotopes , Radionuclides
An atom with an unstable nucleus ,which is a
nucleus characterized by excess energy
available to be imparted wether to a newly
created radiation particle within the nucleus
or to an atomic electron . the radionuclide, in
this process, undergoes radioactive decay ,
and emits gamma ray(S) and /or subatomic
particles.
9. Radioactivity
• The process in which an
unstable isotope
undergoes changes until
a stable state is reached
and in the
transformation emits
energy in the form of
radiation (alpha particles
, beta particles and
gamma rays)
10. Types of radiocativity
• Natural radioactivity
Nuclear reactions occur spontaneously
• Artificial radioactivity
The property of radioactivity produced by
particle bombardment or electmagnetic
radiation.
11. How to produce radioactive nuclide
a) Charged particle reaction:
(e.g) Protons
Deutrons (A=2)
Alpha particles
b) Photon induced reaction:
The source of electromegnatic energy may be gamma
emitting radionuclide or high voltage x-ray generator
c) Neutron induced reaction:
Most widely used method. It is bombardment of
nonradioactive target nucleus with a source of
thermal neutrons
12. Radioactive decay
• Radioactive decay is the process in which
unstable atomic nucleus spontaneously loses
energy by emitting ionizing particles and
radiation.
• This decay, or loss of energy , results in an
atom of one type ,called the parent nuclide
transforming to an atom of a different type,
named the daughter nuclide.
14. • Half life (t ½): the time taken for the activity
of a given amount of a radioactive substance
to decay to half of its initial value
• Total activity (A): number of decays an object
undergoes per second.
• Radionuclidic purity: is that percentage of the
total radioactivity that is peresent in the form
of the stated radionuclide.
15. Mode of radioactive decay
When an unstable nuclide decays, it may give
out
1- Alpha particles
2- Beta particles
3- Gamma rays
16. Type of
radiation
Alpha rays Beta rays Gamma rays
symbol α²⁺ (β) (γ )
charge +2 -1 0
Speed slow fast very fast
Ionizing ability high medium 0
Penetrating
power
low medium high
Stopped by: paper aluminium lead
TYPES OF RADIOACTIVE DECAY
17. Radiation measurement
The basic unit for quantifying radioactivity is
“curie (Ci)”. It describes the rate at which
nuclei decay.
Curie named for famed scientist Marie Curie
Becquerel (Bq) :
A unit of radioactivity. 1 becqueral is equal to
one disintegration per second
19. 1-Charged particle bombardment
Radionuclides may be produced by bombarding
target materials with charged particles in particle
accelerators such as cylortons.
Cyclotron: an apparatus in which charged atomic
and subatomic particles are accelerated by an
alternating electric field while following an
outward spiral or circular path in a magnetic field.
cyclotron consists of:
• Two flat hollow objects called dees .
• The dess are part of an electrical circuit.
20. • on the other side of the dees are large
magnets that steer (drive) the injected
charged particles (protons, deutrons, alpha
and hellium ) in a circular path.
• the charged particle follows a circular path
untlil the particle has sufficient energy that it
passes out of the field and interact with the
target nucleus.
21.
22. 2-Neutron bombardment
Radionuclides may be produced by
bombarding target materials with neutrons in
nuclear reactors.
• The majority of radiopharmaceuticals are
produced by this process.
23. 3-Radionuclide generator systems
• Principle:
A long – lived parent radionuclide is allowed
to decay to its short- lived daughter
radionuclide and the latter is chemically
separated in physiological solution.
• Example
Technetium – 99m, obtained from a generator
constructed of molybdenum-99 absorbed to
an alumina column.
25. Compounding
• Can be as simple as :
Adding a radioacitive liquid to a commercially available
reagent kit
• Can be as complex as :
The creation of a multi – component reagent kit
Kit for radiopharmaceutical preparation: Means a sterile
and pyrogen- free reaction vial containing the non
radioctive chemicals {e.g ,complexing agent(ligand),
reducing agent, stabilizer, or disepersing agent} that are
required to produce a specific radiopharmaceutical after
reaction with a radioactive component.
26. Caution
• The process of compounding
radiopharmaceuticals must be
under the supervision of
recognized nuclear physician
or a radio pharmacist.
27. Sterilization
Radiopharmaceutical prepartions intended for
parenteral admininstration are sterilized by a
suitabled method.
• Terminal sterilization by outoclaving is
recommended for heat stable products.
• For heat labile products , the filtration method
is recommended.
28. Stability of compounded
Preparation
• All extmporaneously compounded parenteral
radiopharmaceutical prepartations should be
used not more than 24 hours post
cmpounding process unless data are available
to support longer storage.
31. • Visual inspection of product
Visual inspection of the compounded radiopharmaceutical
shall be conducted to ensure the absence of foregin matter
and also to establish product identitiy by confirming that
• A liquid product is solution, a colloid , or a suspension.
• A solid product has defined properties that identify it.
• Assessment of radioactivity
the amount of radioactivity each compounded
radiopharmaceutical should be verified and documented
prior to dispenisng, using a proper standardized
radionuclide (dose) calibrator.
32.
33. • Radionuclidic purity
Radionuclidic purity can be determined with the use of a suitables
counting device
• The gamma-ray spectrum, sholuld not be signifcantly different from
that of standardized solution of the radionclide.
• Radiochemical purity
Radiochemical purity is assessed by a variety of analytical techniques
such as:
• Liquid chromagraphy
• Paper chromatagraphy
• Thin- layer chromagraphy
• Electophoresis
• The distibution of radioactivity on the chromatogram is determined.
34. • Ph
• Microbiological control (sterilitly test) and bacterial
Endotoxin testing
• Labeling
• The label on the outer package should inclulde:
• a statement that the product is radioactive or the
international symbol of radioactivity.
• The name of the radiopharmaceutical preparation:
The perparation is for diagnostic for therapeutic use
• The total radioactivity present (for example , in MBq per
ml of the solution)
35. Route of administration
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
