To my Senior CEU Pharmacy QC 2 Students. Radiopharmacy, Nuclear Pharmacy QC and cGMP protocols in handling, storage and preparation of various radiopharmaceuticals containing various radio-isotopes. Examples and Medical Applications included.

1. CHAPTER 8:
RADIOPHARMACEUTICALS:
PRODUCTION AND TESTING
ASST. PROF. MA. LOURDES LICSI – MOJARES, RPh
SCHOOL OF PHARMACY
CEU, Manila

2. RADIOPHARMACEUTICALS:
DEFINITION
MEDICINAL PRODUCTS WHICH CONTAIN A
RADIOACTIVE NULEUS.
ITS CLINICAL USE (DIAGNOSIS OR THERAPY)
IS TOTALLY DEPENDENT ON THE PRESENCE
OF THIS RADIOACTIVE ENTITY.

3. NUCLEAR PHARMACY
MAKES USE OF SPECIFIC RADIOTRACERS
FOR IMAGING ORGAN FUNCTIONS AND
DISEASED STATES.
CAPABLE OF MAPPING PHYSIOLOGIC
FUNCTION AND METABOLIC ACTIVITY, TO
GIVE MORE SPECIFIC INFORMATION
ABOUT ORGAN FUNCTION /
DYSFUNCTION.

4. IN VIVO MAPPING OF
RADIOPHARMACEUTICAL DISTRIBUTION
PROVIDE IMAGES OF FUNCTIONAL
MORPHOLOGY OF ORGANS IN A NON-INVASIVE
MANNER.
PLAYS AN IMPORTANT ROLE IN DIAGNOSIS
OF MANY COMMON DISEASES ASSOCIATED
WITH THE MALFUNCTIONING OF ORGANS
IN THE BODY.

5. IN VIVO MAPPING OF
RADIOPHARMACEUTICAL DISTRIBUTION
DETECTION OF CERTAIN TYPES OF
CANCERS.
MAPPING IS NOT POSSIBLE IN
NUCLEAR MAGNETIC IMAGING (MRI)
COMPUTED TOMOGRAPHY (CT)
ULTRASONOGRAPHY (US)

6. RADIOPHARMACEUTICALS:
DEFINITION
MEDICINAL PREPARATIONS THAT
CONTAIN RADIOACTIVE ISOTOPES WHICH
ARE SAFE FOR ADMINISTRATION IN
HUMANS FOR ;
DIAGNOSIS
THERAPY

7. RADIOPHARMACEUTICALS:
FUNCTIONS AND USES
MEDICINAL PREPARATIONS THAT
MEASURE SEVERAL CAUSAL FACTORS TO
PROVIDE USEFUL INFORMATION ABOUT
THE;
A. CELLULAR FUNCTION OF A TUMOR
B. MOLECULAR BIOLOGY OF A TUMOR

8. RADIOPHARMACEUTICALS:
APPLICATIONS
CYCLOTRONS
FIRST USED TO ACCELERATE PARTICLES,
FOR THE PRODUCTION OF ISOTOPES.
EARLIER USED FOR THE PRODUCTION OF;
1. LONG-LIFE ISOTOPES
2.TRACERS FOR DIAGNOSTIC IMAGING

9. RADIOPHARMACEUTICALS:
APPLICATIONS
NUCLEAR REACTORS
USED FOR THE PREPARATION OF LARGER
QUANTITIES OF RADIO ISOTOPES.
HIGH FLUX AND MEDIUM FLUX NUCLEAR
RESEARCH REACTORS
USED FOR ROUTINE PRODUCTION OF
ISOTOPES FOR MEDICAL APPLICATIONS,
AS ITS PRIORITY.

10. RADIOPHARMACEUTICALS:
PRODUCED THRU HIGH-FLUX /
MEDIUM-FLUX NUCLEAR RESEARCH
MOLYBDENUM-99
PHOSPHORUS-32
CHROMIUM-51
STRONTIUM-89
SAMARIUM-153
RHENIUM-186
LUTETIUM-177

11. RADIOPHARMACEUTICALS:
PREPARATIONS
RADIOIODINE (IODINE 131)
FIRST INTRODUCED IN 1946 FOR THE
TREATMENT OF THYROID CANCER.
THE MOST EFFECTIVE FOR THE
TREATMENT OF THYROID CANCER AND
HYPERTHYROIDISM.

12. RADIOPHARMACEUTICALS:
PREPARATIONS
SINGLE EMISSION POSITRON
TOMOGRAPHY (SPECT)
EMPLOY MEDIUM TO HIGH ENERGY
CYCLOTRONS (20 TO 70 MEV) WITH HIGH
BEAM CURRENTS.

13. RADIOPHARMACEUTICALS:
PREPARATIONS
SINGLE EMISSION POSITRON
TOMOGRAPHY (SPECT) USING 20 TO 70 MEV
THALLIUM-201
IODINE-123
INDIUM-111

14. RADIOPHARMACEUTICALS:
PREPARATIONS
POSITRON EMISSION TOMOGRAPHY
USING LOW ENERGY CYCLOTRONS OF 9 TO
19 MEV
USED FOR THE PRODUCTION OF SHORT-LIVED
RADIONUCLIDES.
FLUORINE-18, CARBON-11, NITROGEN-13,
OXYGEN-15.

15. RADIOPHARMACEUTICALS:
PRODUCTION ASPECTS
MANAGEMENT OF RADIOISOTOPE
PRODUCTION
IMPORT, OPERATION AND MAINTENANCE
OF PROCESSING FACILITIES
COMPLIANCE WITH CODES OF CGMP

16. RADIOPHARMACEUTICALS:
PRODUCTION ASPECTS
ENSURING EFFECTIVE QC/QA SYSTEMS
REGISTRATION OF THE PRODUCTS WITH
NATIONAL / REGIONAL HEALTH
AUTHORITIES.
SAFE TRANSPORT

17. RADIOPHARMACEUTICALS:
CGMP COMPLIANCE
DEVELOPMENT OF WELL-QUALIFIED
PERSONNEL
USE OF CONTROLLED MATERIALS AND
PROCEDURES
AVAILABILITY OF QUALIFIED EQUIPMENT,
PRODUCTION IN DESIGNATED CLEAN
AREAS

18. RADIOPHARMACEUTICALS:
CGMP COMPLIANCE
FULL DOCUMENTATION OF THE PROCESS
RELEASE OF THE FINAL PRODUCT BY A
QUALIFIED PERSON

19. RADIOPHARMACEUTICALS:
TECHNETIUM-99M
MOST WIDELY USED RADIOISOTOPE IN
NUCLEAR MEDICINE.
OVER 8O % OF THE NEARLY 25 MILLION
DIAGNOSTIC NUCLEAR MEDICINE STUDIES
CARRIED OUT YEARLY ARE DONE WITH
THIS SINGLE ISOTOPE.

20. RADIOPHARMACEUTICALS:
TECHNETIUM-99M
SHORT-LIVED TECHNETIUM 99-M ( HALF
LIFE IS 6 HOURS) IS THE DAUGHTER OF THE
LONG-LIVED MOLYBDENUM 99 (HALF LIFE IS
66 HOURS).
IT IS OFTEN FORMULATED FROM “COLD
KITS.”

21. TECHNETIUM 99M PRODUCTION
TECHNETIUM IS TREATED WITH
SODIUM PERTECHNETATE
SOLUTION, ELUTED FROM THE
TECHNETIUM 99M GENERATOR.
THE FINAL PRODUCT FOR PATIENT
INJECTION IS DIRECTLY FORMED.

22. PRODUCTION OF COLD KITS
PREPARED IN SUCH A MANNER TO
HAVE A LONG SHELF LIFE.
MAY BE TRANSPORTED AT ROOM
TEMPERATURE.
STORED UNDER REFRIGERATION
TO ENSURE STABILITY.

23. RADIOPHARMACEUTICALS:
QUALITY CONTROL AND ASSURANCE
RADIONUCLIDE CONCENTRATION
ACCURATE ASSAY OF THE ADMINISTERED
LEVELS OF ACTIVITY.
ESSENTIAL IN THE CONTROL OF
ABSORBED RADIATION DOSE
(BECQUEREL)

24. RADIOPHARMACEUTICALS:
QUALITY CONTROL AND ASSURANCE
RADIONUCLIDE PURITY
MEASURES THE PROPORTION OF THE
TOTAL ACTIVITY PRESENT IN THE FORM OF
STATED RADIONUCLIDE, EXPRESSED IN %.
INVOLVES ASSAY FOR RADIOACTIVE
CONTENT.
DOES NOT IDENTIFY THE NUCLIDE GIVING
RISE TO RADIOACTIVITY.

25. RADIOPHARMACEUTICALS:
QUALITY CONTROL AND ASSURANCE
CHEMICAL / RADIOCHEMICAL PURITY
THE PROPORTION OF THE TOTAL ACTIVITY
PRESENT IN THE FORM OF A STATED
CHEMICAL.
INVOLVES SEPARATION AND
QUANTITATIVE ANALYSIS OF THE ACTIVE/S
BY CHROMATOGRAPHY, GEL FILTRATION
OR ELECTROPHORESIS.

26. RADIOPHARMACEUTICALS:
QUALITY CONTROL AND ASSURANCE
STERILITY
APYROGENECITY
ABSENCE OF PARTICULATE MATTER
PARTICLE SIZE
PH
BIOLOGICAL DISTRIBUTION

27. THERAPEUTIC
RADIOPHARMACEUTICALS
RADIOPHARMACEUTICALS LABELED
WITH BETA-EMITTING RADIONUCLIDES.
MANAGEMENT OF THYROID CANCER.
IMPROVE THE QUALITY OF LIFE OF
PATIENTS FROM PAIN ASSOCIATED
WITH BONE METASTASIS.

28. THERAPEUTIC
RADIOPHARMACEUTICALS
TREATMENT OF JOINT PAINS SUCH
AS RHEUMATOID ARTHRITIS.

29. RADIOPHARMACEUTICALS FOR
BONE PAIN PALLIATION
RADIOPHARMACEUTICALS
CONTAINING RADIONUCLIDES
SUCH AS;
strontium-89
samarium-153
rhenium 186/188

30. RADIOPHARMACEUTICALS FOR
JOINT PAIN PALLIATION
FOR PATIENTS SUFFERING FROM
BREAST, LUNG OR PROSTATE CANCER.
PATIENTS WHO DEVELOP METASTASIS
FROM THE BONES.

31. RADIOPHARMACEUTICALS FOR
JOINT PAIN PALLIATION
PATIENTS IN THE ADVANCED
STAGE OF THEIR DISEASES.
Lutetium-177 BASED
RADIOPHARMACEUTICAL CAN BE
PREPARED IN LARGE QUANTITIES
FROM LOW / MEDIUM FLUX
NUCLEAR REACTORS.

32. RADIOPHARMACEUTICALS FOR
PRIMARY CANCER TREATMENT
PRRT (PEPTIDE RECEPTOR RADIONUCLIDE
THERAPY)
RADIO-LABELED PEPTIDES AS MOLECULAR
VECTORS ARE BEING DEVELOPED FOR
TARGETED THERAPY.
THESE RADIO-LABELED PEPTIDE MOLECULES
WILL HAVE THE POTENTIAL TO DESTROY
RECEPTOR – EXPRESSING TUMORS.

33. RADIONUCLIDES USED IN PRRT STUDIES
YTTRIUM-90
LUTETIUM- 177
THESE RADIOPHARMACEUTCALS SELECTIVELY
DELIVERS CYTOTOXIC LEVELS OF RADIATION
TO A DISEASED SITE.
THESE WILL DELIVER THE ABSORBED
RADIATION DOSE MORE SELECTIVELY TO THE
CANCEROUS TISSUES.

34. RADIOPHARMACEUTICALS FOR
RADIOSYNOVIORTHESIS /
RADIOSYNOVECTOMY
TECHNIQUE WHEREIN THE
RADIOPHARMACEUTICAL IS DELIVERED
INTO THE AFFECTED SYNOVIAL
COMPARTMENT OF PATIENTS
SUFFERING FROM JOINT PAIN (such as
RA).
BETA-EMITTING RADIO COLLOIDS ARE
WIDELY USED FOR THIS PURPOSE.

35. RADIOPHARMACEUTCALS DEVELOPED
FOR RADIOSYNOVIORTHESIS
PHOSPHORUS-32
YTTRIUM-90
SAMARIUM-153
HOLMIUM-166
ERBIUM-169
LUTETIUM-177
RHENIUM-186

36. RADIOPHARMACEUTICALS
PACKAGING

37. HOT CELLS in RADIOPHARMACEUTICALS