Preparation of radiopharmaceuticals for clinical administration necessi-tates several considerations.
Formulation of
radiopharmaceuticals
Preparation
of radiopharmaceuticals for clinical administration necessi-tates several
considerations. For example:
1. Sterility: All formulations
intended for parenteral administration need
to be manufactured under aseptic conditions that provide a rea-sonable
assurance of sterility. In addition, absence of microbial con-tamination needs
to be shown periodically to validate such a working environment. Aseptic
filtration as the final step in the process and/or terminal sterilization after
packaging in the final container, for exam-ple, by autoclaving, are the
preferred practices that ensure sterility of the formulation in the final
product container.
2. Pyrogens and
endotoxin limit: Endotoxins are bacterial cell-wall components that can elicit fever response in humans and are
there-fore called pyrogenic. Endotoxin content of the formulations must be
within the limits that would ensure that the rate and total daily amount of endotoxin
intake in the patients stay below acceptable regulatory limits. The endotoxin
limit for human administration is limited to five endotoxin units (as defined
by the United States Pharmacopeia [USP]) per kilogram per hour (in the case of
infusion) for intravenous (IV) administration. All incoming raw materials,
including glassware contact surfaces and packaging materials, and processing
techniques can contribute to the endotoxin content of the final formulation.
3. Adsorption of the radiopharmaceutical to the container of
storage or dispensing can lead to reduced dose or potency administered to the
patient. This can be obviated by using silicone-coated low-adsorption
containers as—well as by using inert carrier-loaded radiopharmaceu-ticals,
which have lower diffusivity and adsorption potential.
Certain
radioisotopes have short half-life, which introduces additional complexity in
their use. For example, 99mTc and 113mIn have a short
half-life. The parenteral formulations of these radioisotopes must be prepared
in the clinic under aseptic conditions, ideally immediately before
administration to the patient.
Institutions,
such as hospitals, that handle radioisotopes have a medical isotope committee
to carefully guide, monitor, and control the handling of the radioisotopes to
maintain patient and user safety. Generally, the institutional medical isotope
committee is charged with the responsibil-ity to define the specific details of
radioisotope use and disposal, such as facilities, storage requirements, inventory
requirements, and personnel procedures.
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