Radiopharmaceutical products

Patent metadata

Field	Value
Publication number	US-10328164-B2
Application number	US-30597707-A
Country	US
Kind code	B2
Filing date	Jun 21, 2007
Priority date	Jun 21, 2006
Publication date	Jun 25, 2019
Grant date	Jun 25, 2019

Abstract

The present invention relates to improved radiopharmaceutical compositions in sealed containers, where the container closure has an ETFE (ethylene-tetrafluoroethylene copolymer) coating. Also disclosed are kits for radiopharmaceutical preparation using the sealed containers, as well as methods of preparation of radiopharmaceuticals using the sealed containers.

First claim

What is claimed is:

1. An imaging agent product comprising a tetrofosmin composition within a sealed container,
the sealed container comprising a pharmaceutical grade glass vial and pre-treated closure suitable for puncturing with a hypodermic needle while maintaining seal integrity, the pre-treated closure comprising a chlorinated butyl rubber body which is coated with ethylene-tetrafluoroethylene copolymer (ETFE) on one or more of its surface(s) which are in contact with the container contents, wherein the pre-treatment of the closure removes oxygen gas dissolved within the closure material so that the sealed container exhibits a headspace having an increase in oxygen of less than 2 microliters after 11 weeks post-sealing;
the tetrofosmin composition comprises a lyophilized, non-radioactive formulation having a pH in the range of 8.0 to 9.2 in the sealed container, the formulation comprising:
(i) a tetrofosmin precursor,
(ii) an optional radioprotectant selected from ascorbic acid or a salt thereof with a biocompatible cation;
(iii) a biocompatible reductant that comprises stannous ion; and
(iv) an effective amount of a pH-adjusting agent that is sodium bicarbonate, sodium hydrogen carbonate, or a combination thereof;

wherein the tetrofosmin composition is sealed within the sealed container under nitrogen gas with the pre-treated closure such that the sealed container exhibits reduced losses of tetrofosmin relative tetrofosmin compositions sealed within a container having an uncoated rubber body, and wherein upon reconstitution with 99m Tc the imaging agent the product yields a 99m Tc-tetrofosmin imaging agent.

2. The imaging agent product of claim 1 , where the coating is laminated onto the closure.

3. The imaging agent product of claim 1 , where the coating covers all surfaces of the closure except those which form the sealing area with the container.

4. The imaging agent product of claim 1 , wherein the closure is pre-treated by heating in a dry oven.

5. The imaging agent product of claim 1 , wherein the closure is pre-treated by heating the closure to remove oxygen gas dissolved within the closure material and/or coating and re-equilibrating the closure under an atmosphere of a chemically unreactive gas.

6. The imaging agent product of claim 1 , where the closure has a single vent igloo shape.

7. The imaging agent product of claim 1 , wherein the tetrofosmin composition consists essentially of about 0.69 mg tetrofosmin, about 90 μg of stannous chloride dihydrate, about 0.96 mg disodium sulfosalicylate, about 3.0 mg sodium D-gluconate, about 5.0 mg ascorbic acid, about 11.0 mg sodium hydrogen carbonate, and a pH on reconstitution of 8.3 to 9.1.

8. A kit for the preparation of an imaging agent comprising the imaging agent product of claim 1 and a sterile sodium 99m Tc pertechnetate.

Assignees

• Hemstad Stig
• Ge Healthcare Ltd

Inventors

• Hemstad Stig

Classifications

• A61P43/00

  Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 · CPC title

• A61K51/1286 Primary

  Ampoules, glass carriers carrying the therapeutic or in vivo diagnostic agent · CPC title

• A61K51/02

  characterised by the carrier {, i.e. characterised by the agent or material covalently linked or complexing the radioactive nucleus} · CPC title

• A61J1/1468

  Containers characterised by specific material properties · CPC title

• A61J1/1406 Primary

  Septums, pierceable membranes · CPC title