Classifications

• • A—HUMAN NECESSITIES
  • A47—FURNITURE; DOMESTIC ARTICLES OR APPLIANCES; COFFEE MILLS; SPICE MILLS; SUCTION CLEANERS IN GENERAL
  • A47L—DOMESTIC WASHING OR CLEANING; SUCTION CLEANERS IN GENERAL
  • A47L9/00—Details or accessories of suction cleaners, e.g. mechanical means for controlling the suction or for effecting pulsating action; Storing devices specially adapted to suction cleaners or parts thereof; Carrying-vehicles specially adapted for suction cleaners
  • A47L9/20—Means for cleaning filters
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
  • A61K51/12—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by a special physical form, e.g. emulsion, microcapsules, liposomes, characterized by a special physical form, e.g. emulsions, dispersions, microcapsules
  • A61K51/1206—Administration of radioactive gases, aerosols or breath tests
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
  • A61K51/12—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by a special physical form, e.g. emulsion, microcapsules, liposomes, characterized by a special physical form, e.g. emulsions, dispersions, microcapsules
  • A61K51/1282—Devices used in vivo and carrying the radioactive therapeutic or diagnostic agent, therapeutic or in vivo diagnostic kits, stents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K2121/00—Preparations for use in therapy
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K2123/00—Preparations for testing in vivo

Definitions

• This invention relates to a novel process for the production of a pharmaceutically acceptable saline solution contaiuing a radioactive gas and use thereof.
• this invention relates to a novel process for preparing saline solutions containing a radioactive gas which are useful in radiopharmaceutical diagnostic applications.
• this invention relates to saline solutions containing a radioactive gas, the unit dosages of which, when administered from the same vial, contain essentially the same concentrations of radioactive gas.
• Radioactive gases are extremely useful tools for diagnosis.
• High purity radioactive xenon-133 is used primarily as a radioisotope in a variety of medical research and diagnosis. It is well suited for studies of the rate of blood flow in the various parts of the body as well as for perfusion studies of the lungs.
• H. Lysgaard and H. Lefevre have reported in Acta Obstet. Gynec. Scand 44:401-7, 1965, the measurement with xenon-133 of the myometrial blood flow in the fetus.
• the radioactive isotope is administered as a gas dissolved in a saline solution.
• One of the major problems encountered in this technique is that the gas comes out of solution very readily, and hence when multiple doses are withdrawn from the same vial, a significant portion of the gas escapes from the saline into the supernatent gas space, decreasing the concentration of the radioactive gas in the remaining saline. Consequently, subsequent doses from the same vial contain appreciably lower radioactive xenon than previous doses.
• a further object of this invention is to provide a novel process wherein saline solutions of a constant concentration of radioactive gas can be prepared.
• Another object, is to provide a novel process for the withdrawal of multiple dosage units of the saline solution wherein the radioactive gas concentration is essentially the same,
• the present invention is directed to a novel process for the preparation of pharmaceutically acceptable saline solutions containing a constant concentration of a radioactive gas.
• the process comprises the steps of:
• the process of this invention is particularly applicable to the radioactive inert gases, such as the isotopes of xenon and krypton.
• Illustrative gases include, among others, xenon-133, krypton-85, and the like. It has been observed that these gases readily evolve from pharmaceutically acceptable solutions.
• the saline solutions containing the radioactive gas is prepared as follows.
• a sealed ampoule containing xenon-133 is attached to a system containing a dissolution bulb, a water reservoir and a silicone oil reservoir.
• the dissolution bulb contains the correct weight of sodium chloride so that when the dissolution bulb is filled with water a 0.9 percent solution of sodium chloride in water is obtained.
• the whole apparatus is evacuated of air to a residual pressure of less than 10- millimeters of mercury. This evacuation process not only removes air from the dissolution bulb and connecting tubing, but also removes dissolved air from the water.
• the evacuated system is then isolated from the vacuum pump.
• the dissolution bulb is cooled, such as for example, in liquid nitrogen and the break seal of the ampoule is broken, and radioactive gas is condensed into the dissolution bulb.
• the evacuated ampoule is then closed off from the dissolution bulb and degassed water is admitted to the dissolution bulb. The water is stirred and the sodium chloride and radioactive gas is allowed to dissolve in the water.
• the dissolution bulb is normally isolated from the water reservoir but is opened 3 momentarily from time to time to connect the water reservoir so that at the end of the dissolution process no gas space is left in the dissolution bulb.
• silicone oil which is immiscible, insoluble and less dense than the solution is admitted to the dissolution bulb so that the solution is displaced without creating any gas space.
• silicone oil employed is not necessarily critical. However, it preferably should be low density, non-toxic and non-pyrogenic.
• Illustrative silicone oils are those of the formula R SiO(R SiO) SiR wherein R is alkyl and the oils have viscosities within the range of from 7 to 100 centistokes, and higher.
• the present invention is directed to a novel process for the administration of dosage units containing essentially the same concentration of the radioactive gas from the same vial.
• a major disadvantage previously encountered was a concentration gradient in successive unit doses due either to gas evolution or saline dilution.
• this embodiment of the instant invention provides a novel method for administering unit doses of essentially the same concentration.
• the saline solution can be dispersed from the dissolution zone into sealable unit vials until no air space remains. All of the vials so filled from the same run have essentially the same concentration of radioactive gas. Moreover, it is possible by the process of this invention to employ a technique wherein several doses can be withdrawn from the same vial having essen tially the same concentration.
• a sealed, sterile cartridge completely filled with the radioactive gas saline solution, an aspirator, and a syringe For example, a 1.8 cubic centimeter cartridge (63 millimeters in length) containing the gas saline solution is inserted piston end first into the syringe barrel of a short size aspirator, such as the Carpule Aspirator from which the needle end has been removed. Thereafter the needle of a 1 cubic centimeter disposable plastic syringe, such as the B-D tuberculin syringe, which has been flushed with saline solution to remove all air bubbles is inserted through the barrel end of the aspirator puncturing the septum of the cartridge.
• a 1 cubic centimeter disposable plastic syringe such as the B-D tuberculin syringe
• the piston of cartridge moves inwardly forcing the saline solution into the plastic syringe spaces filling the syringe to the desired level. Operating in this manner avoids the creation of any gas spaces and permits mult-doses of the same concentration to be obtained.
• Preparation of xenon-133 in isotonic saline solution Clean, dry, and sterilize the whole apparatus. Dry sterilized sodium chloride by heating in oven at 110 C. for 8 hours. Cool sodium chloride in a sterile desiccator. Weigh the correct amount of sodium chloride to make 0.9% sodium chloride solution when dissolved in a volume of water equal to the volume of the dissolution bulb. Transfer the sterile sodium chloride into the dissolution bulb. Place a clean, dry sterile Teflon or glass covered magnetic stirring bar into the dissolution bulb. Put 500 ml. of sterile pyrogen-free water and a clean, dry, sterile Teflon coated magnetic stirring bar into a sterilized water reservoir.
• a process for the preparation of a pharmaceutically acceptable saline solution containing a constant concentration of a radioactive gas which comprises the steps of:
• a process for the preparation of a pharmaceutically acceptable saline solution containing a constant concentration of a radioactive gas which comprises the steps of:

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• Health & Medical Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Physics & Mathematics (AREA)
• Life Sciences & Earth Sciences (AREA)
• Optics & Photonics (AREA)
• Epidemiology (AREA)
• Veterinary Medicine (AREA)
• Pharmacology & Pharmacy (AREA)
• Dispersion Chemistry (AREA)
• Medicinal Chemistry (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Heart & Thoracic Surgery (AREA)
• Engineering & Computer Science (AREA)
• Mechanical Engineering (AREA)
• Atmospheric Sciences (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

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Publications (1)

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Citations (1)

• 0
  • NL NL686802467A patent/NL139241B/xx unknown
• 1967
  • 1967-01-09 US US607894A patent/US3509919A/en not_active Expired - Lifetime
• 1968
  • 1968-02-08 BE BE710530D patent/BE710530A/xx unknown
  • 1968-02-08 DE DE19681667926 patent/DE1667926A1/de active Pending
  • 1968-02-21 NL NL6802467A patent/NL6802467A/xx unknown

Patent Citations (1)

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