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US-12622845-B2 - Container made from soda-lime glass with improved chemical resistance for a pharmaceutical or diagnostic substance

US12622845B2US 12622845 B2US12622845 B2US 12622845B2US-12622845-B2

Abstract

The invention relates to a container ( 1 ) comprising a wall ( 2 ) made of glass delimiting a cavity ( 3 ) to accommodate a substance, particularly for a pharmaceutical or diagnostic substance, the glass wall ( 2 ) having an internal face ( 4 ) situated facing the accommodating cavity ( 3 ), the container ( 1 ) being characterized in that the wall ( 2 ) is made of soda-lime glass, the internal face ( 4 ) forming a bare glass surface intended to come into direct contact with the substance, the glass wall ( 2 ) having an atomic fraction of sodium, measured by X-ray-induced photoelectron spectrometry, which is less than or equal to 4 at. % down to a depth of at least 200 nm from the surface of the inner face ( 4 ).

Inventors

  • PIERRE-LUC ETCHEPARE
  • CHRISTOPHE DEPOILLY
  • Jingwei Zhang

Assignees

  • SGD S.A.

Dates

Publication Date
20260512
Application Date
20211222
Priority Date
20210111

Claims (20)

  1. 1 . A container ( 1 ) comprising a glass wall ( 2 ) delimiting an accommodation cavity ( 3 ) for a substance, said glass wall ( 2 ) having an inner face ( 4 ) located facing said accommodation cavity ( 3 ), said container ( 1 ) being characterized in that said wall ( 2 ) is made of soda-lime glass, said inner face ( 4 ) forming a bare glass surface intended to come into direct contact with said substance, said glass wall ( 2 ) having anatomic fraction of sodium, as measured by X-ray induced photoelectron spectrometry, that is lower than 4 at. % up to a depth of at least 200 nm from the surface of the inner face ( 4 ).
  2. 2 . The container ( 1 ) according to claim 1 , characterized in that said atomic fraction of sodium is lower than or equal to 3.5 at. % up to a depth of at least 200 nm from the surface of the inner face ( 4 ).
  3. 3 . The container ( 1 ) according to claim 1 , characterized in that said atomic fraction of sodium is lower than or equal to 3.5 at. % up to a depth of at least 100 nm from the surface of the inner face ( 4 ).
  4. 4 . The container ( 1 ) according to claim 1 , characterized in that said atomic fraction of sodium is lower than or equal to 2.4 at. % up to a depth of 30 nm from the surface of the inner face ( 4 ).
  5. 5 . The container ( 1 ) according to claim 1 , characterized in that said atomic fraction of sodium is lower than or equal to 2.0 at. % up to a depth of 15 nm from the surface of the inner face ( 4 ).
  6. 6 . The container ( 1 ) according to claim 1 , characterized in that said atomic fraction of sodium is lower than or equal to 1.5 at. % at a depth of 0 nm from the surface of the inner face ( 4 ).
  7. 7 . The container ( 1 ) according to claim 1 , characterized in that said atomic fraction of sodium is lower than or equal to 2.5 at. % up to a depth of at least 200 nm from the surface of the inner face ( 4 ), lower than or equal to 2.0 at. % up to a depth of at least 30 nm from the surface of the inner face ( 4 ), while being lower than or equal to 1.0 at. % at a depth of 0 nm from the surface of the inner face ( 4 ).
  8. 8 . The container ( 1 ) according to claim 1 , characterized in that said glass wall ( 2 ) has a ratio of an atomic fraction of sodium to an atomic fraction of silicon, measured by X-ray induced photoelectron spectrometry, that is lower than or equal to 0.130 up to a depth of at least 200 nm from the surface of the inner face ( 4 ).
  9. 9 . The container ( 1 ) according to claim 1 , characterized in that said glass wall ( 2 ) has a ratio of an atomic fraction of sodium to an atomic fraction of silicon, measured by X-ray induced photoelectron spectrometry, that is lower than or equal to 0.130 up to a depth of at least 100 nm from the surface of the inner face ( 4 ).
  10. 10 . The container ( 1 ) according to claim 1 , characterized in that said glass wall ( 2 ) has a ratio of an atomic fraction of sodium to an atomic fraction of silicon, measured by X-ray induced photoelectron spectrometry, that is lower than or equal to 0.080 up to a depth of at least 30 nm from the surface of the inner face ( 4 ).
  11. 11 . The container ( 1 ) according to claim 1 , characterized in that said glass wall ( 2 ) has a ratio of an atomic fraction of sodium to an atomic fraction of silicon, measured by X-ray induced photoelectron spectrometry, that is lower than or equal to 0.080 up to a depth of at least 15 nm from the surface of the inner face ( 4 ).
  12. 12 . The container ( 1 ) according to claim 1 , characterized in that said glass wall ( 2 ) has a ratio of an atomic fraction of sodium to an atomic fraction of silicon, measured by X-ray induced photoelectron spectrometry, that is lower than or equal to 0.050 at a depth of 0 nm from the surface of the inner face ( 4 ).
  13. 13 . The container ( 1 ) according to claim 1 , characterized in that said glass wall ( 2 ) has a ratio of an atomic fraction of calcium to an atomic fraction of silicon, measured by X-ray induced photoelectron spectrometry, that is lower than or equal to 0.240 up to a depth of at least 200 nm from the surface of the inner face ( 4 ).
  14. 14 . The container ( 1 ) according to claim 1 , characterized in that said glass wall has a ratio of an atomic fraction of calcium to an atomic fraction of silicon, measured by X-ray induced photoelectron spectrometry, that is lower than or equal to 0.230 up to a depth of at least 100 nm from the surface of the inner face ( 4 ).
  15. 15 . The container ( 1 ) according to claim 1 , characterized in that said glass wall has a ratio of an atomic fraction of calcium to an atomic fraction of silicon, measured by X-ray induced photoelectron spectrometry, that is lower than or equal to 0.210 up to a depth of at least 30 nm from the surface of the inner face ( 4 ).
  16. 16 . The container ( 1 ) according to claim 1 , characterized in that said glass wall ( 2 ) has a ratio of an atomic fraction of calcium to an atomic fraction of silicon, measured by X-ray induced photoelectron spectrometry, that is lower than or equal to 0.200 up to a depth of at least 15 nm from the surface of the inner face ( 4 ).
  17. 17 . The container ( 1 ) according to claim 1 , characterized in that said glass wall has a ratio of an atomic fraction of calcium to an atomic fraction of silicon, measured by X-ray induced photoelectron spectrometry, that is lower than or equal to 0.050 at a depth of 0 nm from the surface of the inner face ( 4 ).
  18. 18 . The container ( 1 ) according to claim 1 , characterized in that said glass wall ( 2 ) has a ratio of an atomic fraction of aluminium to an atomic fraction of silicon, measured by X-ray induced photoelectron spectrometry, that is lower than or equal to 0.040 up to a depth of at least 200 nm from the surface of the inner face ( 4 ).
  19. 19 . The container ( 1 ) according to claim 1 , characterized in that said glass wall ( 2 ) has a ratio of an atomic fraction of aluminium to an atomic fraction of silicon, measured by X-ray induced photoelectron spectrometry, that is lower than or equal to 0.040 up to a depth of at least 100 nm from the surface of the inner face ( 4 ).
  20. 20 . The container ( 1 ) according to claim 1 , characterized in that said glass wall ( 2 ) has a ratio of an atomic fraction of aluminium to an atomic fraction of silicon, measured by X-ray induced photoelectron spectrometry, that is lower than or equal to 0.050 up to a depth of at least 30 nm from the surface of the inner face ( 4 ).

Description

This is a National Phase Application filed under 35 U.S.C. 371 as a national stage of PCT/FR2021/052429, filed Dec. 22, 2021, an application claiming the benefit of French Patent Application No. 2100213, filed Jan. 11, 2021, the content of each of which is hereby incorporated by reference in its entirety. TECHNICAL FIELD The present invention relates to the general technical field of glass containers, in particular for the packaging of pharmaceutical or diagnostic substances. PRIOR ART In the field of pharmaceutical glass primary packaging, the purpose is to propose containers, in particular of the vial type, that have an excellent chemical compatibility with the product or preparation they are intended to contain. Indeed, the aim is to prevent any harmful interaction between a species from the glass forming the container and the product contained by the latter. In this context, the pharmacopoeias identify three main different types of glass containers, which may be acceptable for a pharmaceutical use according to the nature of the considered preparation or substance. These containers are classified according to their level of chemical resistance, i.e. according to the resistance shown by the glass, of which they are formed, to the transfer of water-soluble inorganic substances in determined conditions of contact between the surface of the considered glass contain and the water. A distinction is made between the borosilicate glass containers, said of “Type I”, which have intrinsically an excellent chemical resistance and which thus suit for most pharmaceutical substances and preparations, and the conventional soda-lime-silica glass containers, said of “Type III”, whose chemical resistance is far less advantageous. That way, the use of these latter is limited to non-aqueous vehicle preparations for parenteral use, to the powders for parenteral use (except freeze-dried preparations) and to the preparations for non-parenteral use. A distinction is also made between so-called “Type II” glass containers, which are conventional soda-lime-silica glass containers, like the Type III ones, but whose inner face has been subjected to a specific surface treatment in order to significantly improve their hydrolytic resistance. Type II glass containers thus have an intermediate chemical resistance between those of the Type II glass containers and the Type I glass containers, which make them suitable for packaging most of the acid and neutral aqueous preparations. Although particularly resistant on a chemical point of view, Type I glass containers are generally more complicated and expensive to produce than Type II and Type III containers, which substantially limits the use thereof. The chemical resistance of Type II glass containers, although being better than that of Type III glass containers, however remains sometimes insufficient with respect to the aggressive nature of the preparation the container is intended to contain and/or with respect to the chemical sensitivity of this preparation to certain species of the glass liable to migrate out of the latter during the preparation storage period. That is why it is sometimes contemplated to cover the inner face of the glass wall of the soda-lime glass containers with a barrier coating, for example made of pure silica SiO2 or silicone-based. Nevertheless, the implementation of such a barrier coating makes the manufacturing of the containers more complex and more expensive. DISCLOSURE OF THE INVENTION As a result of the foregoing, the objects assigned to the present invention aim to propose a new glass wall container having an excellent chemical resistance while being relatively inexpensive to manufacture. Another object of the invention aims to propose a new glass wall container that is moreover particularly easy to manufacture. Another object of the invention aims to propose a new glass wall container that is safe in terms of health. The objects assigned to the invention are achieved by means of a container comprising a glass wall delimiting an accommodation cavity for a substance, in particular for a pharmaceutical or diagnostic substance, said glass wall having an inner face located facing said accommodation cavity, said container being characterized in that said wall is made of soda-lime glass, said inner face forming a bare glass surface intended to come into direct contact with said substance, said glass wall having an atomic fraction of sodium, measured by X-ray induced photoelectron spectrometry, that is lower than 4 at. % up to a depth of at least 200 nm from the surface of the inner face. The objects assigned to the invention are also achieved by means of a raw container intended to form such a container according to the invention, said raw container comprising a glass wall delimiting an accommodation cavity, said glass wall having an inner face located facing said accommodation cavity, said wall being made of soda-lime glass, said inner face forming a glass surfac