Production of 131-I iodide capsules in Argentina

It is well known that 131I iodide capsules are better suited to be taken by the patient than the corresponding solution. Therefore most Pharmacopeias have monographs for 131I in both pharmaceutical forms: solution or capsules, for diagnosis but principally for therapeutic purposes. In Argentina this radiopharmaceutical has been made commercially available in November 2007. At this time Bacon Laboratories SAIC started its production, authorized by the Health and Nuclear Regulatory Authorities. 131I, in the pharmaceutical form of capsules, have evident advantages in radioprotection for the patients and the personnel involved in its administration. The intake of a 131I provokes frequently that the external part of the mouth (principally if there is a beard and/or a moustache) undergoes an external contamination. This problem is enhanced if the patient has some motor difficulties to take the glass with the solution. In this case he will need assistance from the medical or technical staff, who will receive a much greater radiation dose than in normal cases. In the capsule of 131I iodide, the solution is adsorbed on a sodium phosphate matrix. The capsule is in a plastic tube contained in an appropriate lead shielding. To take the capsule, the patient inclines the open lead shielding containing the capsule in the direction of the mouth. Once the capsule is in the mouth it is swallowed with a little portion of water. After its intake, the radiopharmaceutical is absorbed from the gastrointestinal tract. If a patient is unable to carry out the intake, the assistance by medical or technical staff is easy with practically no radiation harm, since the 131I is shielded by an adequate lead thickness. It is evident that the hands and external face of the patient are also protected since no possibility of contamination exists. The aim of this work is to present the production procedure, the packaging of the capsules and the decrease of the dose received by the involved personnel. All the radionuclide, radiochemical and pharmaceutical quality control procedures required by the U.S. Pharmacopeia are carried out at the laboratory. (author)