Qc of radiopharmaceuticals

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Qc of radiopharmaceuticals

  1. 1. Quality control and applications of Radiopharmaceuticals Presented by Presented by Savita patil Savita patil M.Pharm IIIrd sem M.Pharm IIIrd sem (Pharmaceutics) (Pharmaceutics) Govt. college of pharmacy, Govt. college of pharmacy, Powerpoint Templates Aurangabad. Aurangabad. Page 1
  2. 2. SnapshotSnapshot Introduction QC of radiopharmaceuticals Applications References Powerpoint Templates Page 2
  3. 3. IntroductionRadiopharmaceuticals are unique medicinal formulationscontaining radioisotopes which are used in major clinical areas fordiagnosis and/or therapy.A radiopharmaceutical contains a radioactive moiety with abiodistribution moiety.After administration radiophamaceutical localizes in a specificorgan/ tissue depending on biodistributing moiety. Powerpoint Templates Page 3
  4. 4. QC tests of QC tests of radiopharmaceuticals radiopharmaceuticalsQC of radiopharmaceuticals includes:The purityPotencyBiologic safetySterility andEfficacy of the radiopharmaceuticals.The tests should be faster and effective sinceradionuclidehave short half life. Powerpoint Templates Page 4
  5. 5. The QC tests for most of the radiopharmaceuticals arementioned in pharmacopoeia (EP, BP, etc)The quality control system should include a procedure whichdescribes measures to be taken if unsatisfactory test results areobtained. Powerpoint Templates Page 5
  6. 6. Different quality testsDifferent quality tests Powerpoint Templates Page 6
  7. 7. Parameters of each test Parameters of each test Powerpoint Templates Page 7
  8. 8. A. Physical tests A. Physical tests1.pH and ionic strength: Ideally pH should be 7.4, but it can vary from 2-9. Correct ionic strength achieved by addition of an acid or alkali.2. Physical characteristics: Recognize the color and state of a radiopharmaceuticals Colloidal or aggregated preparations : Identify size by microscope with haemocytometer. Powerpoint Templates Page 8
  9. 9. Importance of particle size determination Importance of particle size determinationSize of particles will determine the site where theradiopharmaceutical will get localized.E.g. 99mTc MAA, Tc-labeled albumin microspheres : 10to 100 µmIf>100µm: cause pulmonary embolismIf <10 µm: Deposits in the reticuloendothelial cells. Powerpoint Templates Page 9
  10. 10. B. Radiochemical testsB. Radiochemical tests 1. Radionuclidic Purity:  % of the total radioactivity that is present in the form of the stated specified radionuclide  Determined by measuring the half-lives and characteristic radiations emitted by individual radionuclides.  γ-ray emission radionuclides : checked with multi-channel analyzer  Pure β emission radionuclides : checked with β- spectrometer or a liquid scintillation counter Powerpoint Templates Page 10
  11. 11. 2. Radiochemical purity:It is the proportion of the radionuclide present in the stated chemical form.Radiochemical purity can be determined any separation technique, andmeasurement of radioactivity.% RCP= radioactivity in the desired chemical/ radioactivity of totalradiopharmaceutical x 100Radiochemical impurities may arise from decomposition due to: (1) action of solvent (2) change in temperature or pH (3) light (4) presence of oxidizing or reducing agents (5) radiolysis Powerpoint Templates Page 11
  12. 12. Powerpoint Templates Page 12
  13. 13. TLC of radiopharmaceuticalsRadiopharmaceutical Stationary phase Mobile phase14 C-urea cellulose butanol-water-acetic acid (12:5:3)123/131 I-hippuran Silica gel chloroform-acetic acid (9:1)131 I-iodocholesterol Silica gel chloroform-ethanol (1:1)111 In-octreotide Silica gel 0.1 M citrate buffer pH 5123 I-iomazenil Silica gel ethyl acetate-ammonia (200:1) Powerpoint Templates Page 13
  14. 14. RadioactivityNecessary to determine since radioactivity will determine the radiationdose to each patient.It is expressed in SI unit Bequrrels (Bq) or Curie, a non SI unit.Where 1 Bq=1 disintegration/secActivity determinations are carried out by isotope dose calibrator.Calibration of dose calibrator Should be done by a reference source,e.g. Co 57,Ra-226 or Cs-137 Powerpoint Templates Page 14
  15. 15. Radioactivity Testing Powerpoint Templates Page 15
  16. 16. 1. Geiger Muller counterPrinciple: Property to cause ionization of a gas,e.g. Argon.Beta particles enter the G-M tube through Mica window Argon gas is ionized Argon ions are attracted to negative electrode. Process continues and net result is to ionize whole vol. of tube equivalent tocurrent Amplification Digital/ audio output Powerpoint Templates Page 16
  17. 17. Geiger Muller counter Powerpoint Templates Page 17
  18. 18. Conti……………….Advantage: It provides a high outputDisadvantage: Efficiencies are low for low energy Beta emitters e.g. 3H. Powerpoint Templates Page 18
  19. 19. 2. Liquid scintillation counterPrinciple: Property of radiation to cause fluorescence.Advantage: can be used for low energy beta emitters, e.g. 3H and 14C.Problem :1. sample preparation: Requirement to have a clear solution ordispersion in non aqueous solvent.2. variable quenching: may reduce efficiency. Powerpoint Templates Page 19
  20. 20. MethodSample is dissolved in solvent with a scintillant material, e.g. DiphenyloxazoleIonizing radiation(B particles) transfers energy from solvent to scintillantmoleculeMolecules are excited to higher state and latter on fluoresce with emission oflight Detected by photomultiplier Powerpoint Templates Page 20
  21. 21. Liquid Scintillaton Counter Powerpoint Templates Page 21
  22. 22. Isotope dilution analysis:• General two methods:• 1.Direct method: Determination of an inactive compound by dilution with a radioactive compound.• 2.Reverse method: Involves the estimation of radionuclide by dilution with an inactive nuclide Powerpoint Templates Page 22
  23. 23. C. Biological tests 1. Sterility: 1. Sterility:  Sterility: It is complete absence of live micro organisms and its spores. Sterility: It is complete absence of live micro organisms and its spores.  Methods used: Methods used:  Procedure: incubate radiopharmaceutical with growth medium  Procedure: incubate radiopharmaceutical with growth medium containing 14C glucose. containing 14C glucose. Bacteria (if any) will metabolize glucose releasing 14CO2.2. Bacteria (if any) will metabolize glucose releasing 14CO Detection of amounts of radioactivity greater than background indicates Detection of amounts of radioactivity greater than background indicates bacterial growth. bacterial growth. Powerpoint Templates Page 23
  24. 24. Cont…2. Incubate the radiopharmaceutical sample in fluid thioglycolate 2. Incubate the radiopharmaceutical sample in fluid thioglycolatemedium at 30to 35ºC for 7 to 14 days For detection of anaerobic bacteria,medium at 30to 35ºC for 7 to 14 days For detection of anaerobic bacteria,or or3. Soyabean-casein digest medium for incubation at20 to 25ºC for 7 to 14 3. Soyabean-casein digest medium for incubation at20 to 25ºC for 7 to 14days. For detection of fungi and aerobic bacteria. days. For detection of fungi and aerobic bacteria. And growth of micro organisms is seen. And growth of micro organisms is seen. Powerpoint Templates Page 24
  25. 25. 2. Pyrogen testingLAL(Limulus ambeocyte lysate) test can be used. LAL (Limulus ambeocyte lysate) test can be used.Methodinvolves incubation of product with lysate of circulating ambeocytes Method involves incubation of product with lysate of circulating ambeocytesof aahorseshoe crab (Limulus polyphenus) . . of horseshoe crab (Limulus polyphenus) Presence of pyrogens will cause the lysate to form the gel. Presence of pyrogens will cause the lysate to form the gel. Powerpoint Templates Page 25
  26. 26. 3. BiodistributionImportantto determine that the agent does localize in the organ of Important to determine that the agent does localize in the organ ofinterest. interest.Procedure: Procedure: Administration of radiopharmaceutical in animals Administration of radiopharmaceutical in animals Ascertain the relative quantity of radioactivity in various organs. Ascertain the relative quantity of radioactivity in various organs. Powerpoint Templates Page 26
  27. 27. Other QC testsApart from above mentioned tests the final product container should bechecked for proper labeling prior to release of product.Written procedure should be for dealing with products failing to meet therequired standard. investigation measures taken to prevent future events documented.Release can only be effected if:The product complies with the specifications The product has been prepared according to Good Radiopharmacy Practice Powerpoint Templates Page 27
  28. 28. Labelling : • the name of the product and the name of the radionuclide; • any product identification code; • the name of the manufacturer; • an identification number (batch number);The label on the • for liquid preparations, the total radioactivity in the container, or theouter package radioactive • concentration per millilitre, at a stated date and, if necessary, hour,should include : and the volume of liquid in container; • for solid preparations, such as freeze-dried preparations, the total radioactivity at a • stated date and, if necessary, hour; • for capsules, the radioactivity of each capsule at a stated date and, if necessary, hour and the number of capsules in the container; • where relevant, the international symbol for radioactivity. Powerpoint Templates Page 28
  29. 29. Applications of Radiopharmaceuticals Powerpoint Templates Page 29
  30. 30. Powerpoint Templates Page 30
  31. 31. Therapeutic Applicatios Of RadiopharmaceuticalsRadiolabelled Molecules DiseaseChromic Phosphate P32 For Lung, Ovarian, Uterine, And Prostate CancersSodium Iodide I 131 Thyroid CancerSamarium Sm 153 Cancerous Bone TissueSodium Phosphate P 32 Cancerous Bone Tissue And Other Types Of CancersStrontium Chloride Sr 89 Cancerous Bone Tissue Powerpoint Templates Page 31
  32. 32. References1. www.scribd.com2. Beckett A.H., Stenlake J.B.; “Practical pharmaceutical chemistry”;4 th edition; CBS publication; pg. no. 509-511.3. IP 2007; vol 1.;2.2.12; , pg.no. 53-54.4. “The radiopharmacy-A technologist’s guide”; pg.no.22 Powerpoint Templates Page 32
  33. 33. Powerpoint Templates Page 33

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