PACKAGING FOR PHARMACEUTICAL PRODUCTS

Abstract

In a packaging for pharmaceutical products, comprising a primary packaging for receiving a dose or several doses of a pharmaceutical product, and a secondary packaging designed as a cardboard box, in which the primary packaging is received, the primary packaging is arranged in an insulation shell having a latent heat storage material and the insulation shell is held in the secondary packaging at a distance on all sides to form an insulation gap.

Claims

1. Packaging for pharmaceutical products, comprising a primary packaging for receiving a dose or several doses of a pharmaceutical product, and a secondary packaging designed as a cardboard box in which the primary packaging is received, characterized in that the primary packaging is arranged in an insulation shell having a latent heat storage material and that the insulation shell is held in the secondary packaging at a distance on all sides from the secondary packaging to form an insulation gap.

2. The packaging according to claim 1, characterized in that the insulation shell surrounds the primary packaging on all sides.

3. The packaging according to claim 1, characterized in, that the primary packaging is designed as a blister pack, ampoule, injection ampoule or vial.

4. The packaging according to claim 1, characterized in that the latent heat storage material contains or is formed by a phase change material.

5. The packaging according to claim 4, characterized in that the phase change material is selected from the group consisting of: paraffin, esters, linear alcohols, ethers, organic anhydrides, salt hydrates, water-salt mixtures, salt solutions and water-based solutions, or mixtures thereof.

6. The packaging according to claim 4, characterized in that the phase change material has a phase transition temperature of 3-10° C.

7. The packaging according to claim 4, characterized in that the phase change material is present in a dimensionally stable enclosure or a plastic enclosure.

8. The packaging according to claim 4, characterized in that the latent heat storage material comprises a carrier material which is dimensionally stable at the use temperature, in which the phase change material is distributed or arranged so that the latent heat storage material is dimensionally stable in a temperature range both below and above the melting point of the phase change material.

9. The packaging according to claim 8, characterized in that the latent heat storage material is dimensionally stable up to a temperature of at least 5° C., above the phase transition temperature of the phase change material.

10. The packaging according to claim 8, characterized in that the insulation shell is produced by injection molding the latent heat storage material.

11. The packaging according to claim 1, characterized in that the insulation shell is adapted in shape to the primary packaging and lies flat against it, in particular said primary packaging on all sides.

12. The packaging according to claim 1, characterized in that the insulation shell is molded onto the primary packaging.

13. The packaging according to claim 1, characterized in that the insulation shell has a modulus of elasticity of 1 to 3,000 N/mm.sup.2.

14. The packaging according to claim 1, characterized in that the insulation shell has a heat-reflecting coating, a metallic coating or a metal foil, on its outside.

15. The packaging according to claim 1, characterized in that the cardboard box has a heat-reflecting coating, a metallic coating or a metal foil, on its inner surface.

16. The packaging according to claim 14, characterized in that the heat-reflecting coating is formed of a metallic, gas-tight coating with an emissivity of <0.5.

17. The packaging according to claim 1, characterized in that the insulation gap is filled with a gas or is evacuated.

18. The packaging according to claim 1, characterized in that at least one layer of a heat-reflecting film is arranged in the insulation gap.

19. The packaging according to claim 1, characterized in that the insulation gap has a thickness of <16 mm.

20. The packaging according to claim 1, characterized in that spacer elements are arranged in order to hold the insulation shell in the secondary packaging at a distance on all sides from the secondary packaging.

21. The packaging according to claim 20, characterized in that the spacer elements consist of the phase change material of the insulation shell or are formed from cardboard elements.

22. The packaging according to claim 1, characterized in that a temperature sensor or a temperature control strip is arranged in the insulation gap, in the latent heat storage material, between the latent heat storage material and the primary packaging or in the primary packaging.

23. Packaging for pharmaceutical products, comprising a secondary packaging designed as a cardboard box, in which a primary packaging for receiving one dose or several doses of a pharmaceutical product can be received, characterized in that the cardboard box contains an insulation shell having a latent heat storage material which encloses an interior space in which the primary packaging can be arranged, and that the insulation shell is held in the cardboard box at a distance from the cardboard box on all sides to form an insulation gap.

Description

[0055] The invention is explained in more detail below with reference to exemplary embodiments shown schematically in the drawing.

[0056] FIG. 1 shows a perspective view of the packaging according to the invention and

[0057] FIG. 2 shows a cross section of the packaging according to FIG. 1.

[0058] In FIGS. 1 and 2, a cardboard box is denoted by 1, which represents the secondary packaging. In the interior of the cardboard box 1, an insulation shell 2 is arranged, which consists of a latent heat storage material or contains such a material. The insulation shell encloses a primary packaging 3, which is designed, for example, as a glass ampoule, which holds a pharmaceutical product in its interior 4. The insulation shell 2 can consist, for example, of two half-shells which can be separated from one another along a separation plane 5 in order to make the primary packaging 3 accessible. As can be seen in FIG. 2, the insulation shell is adapted to the outer shape of the primary packaging 3, so that the insulation shell 2 rests flat against the primary packaging 3, in the present case along a cylindrical surface.

[0059] Between the insulation shell 2 and the cardboard box 1, spacer elements 6 are arranged on all sides, i.e. on all six sides of the cuboid, which ensures that an insulation gap 7 is provided between the insulation shell 2 and the cardboard box 1. The insulation gap 7 is filled with a gas, such as air. To improve the thermal insulation, a heat-reflecting coating 8 or 9, for example in the form of a metal foil, can be applied to the outside of the insulation shell 2 and/or to the inside of the cardboard box 1. A heat-reflecting planar element, for example a metal foil, can also be arranged in the insulation gap 7, as is indicated by way of example with the dashed line 10 in the area between the two right-hand spacer elements 6.

[0060] To control the temperature of the pharmaceutical product, a temperature sensor 11 is also provided, which is directed towards the separation plane 5 if the insulation shell 2 is formed from two half-shells. The temperature sensor 11 can not only monitor the temperature of the pharmaceutical product, but also detect an unauthorized opening of the packaging. If the two half-shells of the insulation shell are separated from one another, the temperature detected by the temperature sensor 11 changes suddenly.