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EP-4740928-A1 - A PHARMACEUTICAL PRODUCT COMPRISING A CONTAINER COMPRISING A PHARMACEUTICAL COMPOUND AND A LABEL HAVING LOWER MIGRATION OF LEACHABLES

EP4740928A1EP 4740928 A1EP4740928 A1EP 4740928A1EP-4740928-A1

Abstract

It has now surprisingly found out that above-mentioned problem can be achieved by a pharmaceutical product, wherein the pharmaceutical product comprises a container comprising a pharmaceutical compound and/or a medical device suitable for receiving the pharmaceutical compound from the container, an enclosure enclosing the container and/or the medical device, and a label comprised by the enclosure, wherein the enclosure comprises at least one wall enclosing a main cavity, wherein the main cavity is a closed cavity, wherein the cavity comprises the container and/or the medical device.

Inventors

  • MEDICO, LEONARD
  • FRAUCHIGER, DANIEL
  • Vallotton, Raphael

Assignees

  • B. Braun Melsungen AG

Dates

Publication Date
20260513
Application Date
20241112

Claims (15)

  1. A pharmaceutical product, wherein the pharmaceutical product comprises - a container comprising a pharmaceutical compound and/or a medical device suitable for receiving the pharmaceutical compound from the container, - an enclosure enclosing the container and/or the medical device, and - a label comprised by the enclosure, wherein the enclosure comprises at least one wall enclosing a main cavity, wherein the main cavity is a closed cavity, wherein the cavity comprises the container and/or the medical device.
  2. The pharmaceutical product according to claim 1, wherein the at least one wall comprises, preferably consists of, at least one polymer film comprising a polymer, preferably a flexible, thermoformable, and/or thermoformed polymer film, more preferably is a flexible polymer film.
  3. The pharmaceutical product according to claim 2, wherein the at least one polymer film is a weldable or sealable polymer film.
  4. The pharmaceutical product according to claims 2 or 3, wherein the polymer film has a haze value measured according to ASTM D1003, Procedure B, of less than 60%, preferably less than 30%, more preferably less than 25%, and most preferably less than 15%.
  5. The pharmaceutical product according to any of the preceding claims 1 to 4, wherein the label is comprised in the main cavity.
  6. The pharmaceutical product according to any of the preceding claims 1 to 4, wherein the enclosure further comprises a label cavity, wherein the label cavity is a closed cavity, and wherein the label is comprised in the label cavity.
  7. The pharmaceutical product according to claim 6, wherein the label cavity and/or the enclosure comprises an opening means.
  8. The pharmaceutical product according to claim 7, wherein the opening means comprises, preferably consists of, a peelable connection, preferably a sealed connection of the at least one polymer film, most preferably a sealed seam of the at least one polymer film.
  9. The pharmaceutical product according to claim 8, wherein the peelable connection of the opening means has a sealing strength according to ASTM F88-94 in the range from 0.15 to 0.7 N/mm, preferably from 0.15 to 0.5 N/mm, and most preferably from 0.15 to 0.35 N/mm.
  10. The pharmaceutical product according to any of the preceding claims 1 to 9, wherein the label comprises, preferably consists of, a sheet.
  11. The pharmaceutical product according to claim 10, wherein the sheet has a thickness in the range of from 10 to 500 µm, preferably 20 to 200 µm.
  12. The pharmaceutical product according to claims 10 or 11, wherein one side of the sheet comprises information printed with a colored ink.
  13. The pharmaceutical product according to claim 12, wherein the side of the sheet opposite to the side comprising information comprises an adhesive.
  14. Use of a pharmaceutical product according to any of the preceding claims 1 to 13 for sterile storing the pharmaceutical compound.
  15. Use of a pharmaceutical product according to any of the preceding claims 1 to 13 for filling the pharmaceutical compound into a medical device.

Description

Technical Field of the Invention The present invention is related to packaging and labelling pharmaceutical products, in particular packaging and labelling container comprising pharmaceutical compounds and/or medical devices. The present invention is further related to the use of such pharmaceutical products. Background of the Invention Pharmaceutical products typically consist of a pharmaceutical compound, preferably an active pharmaceutical ingredient (API), in a suitable dosage form, such as tablets, capsules, solutions, or suspensions. These products must be carefully stored and transported to maintain the integrity and efficacy of the pharmaceutical compound. To achieve this, the pharmaceutical compound is usually contained in a primary container, such as bags, vials, syringes, ampoules, blister packs, or bottles, depending on the dosage form and administration route. The primary container serves to protect the pharmaceutical compound from environmental factors such as moisture, light, and air, which could lead to degradation of the pharmaceutical compound. In addition to the primary container, pharmaceutical products are also typically enclosed in a secondary packaging. This secondary packaging serves both a protective and regulatory function, as it provides additional layers of protection during shipping and handling, while also ensuring compliance with regulatory standards. It is usually a plastic wrapping. In certain cases, the pharmaceutical product may also comprise a medical device that facilitates administration of the compound. For example, (prefilled) syringes, auto-injectors, or inhalers are common devices used for administering specific pharmaceutical compounds. These medical devices are often co-packaged with the pharmaceutical product or integrated into the primary container to ensure proper and efficient delivery of the pharmaceutical compound to the patient. To provide important data about the pharmaceutical product, the primary container needs to have either a printed label attached to the primary container, or a screen directly printed onto the primary container. Sometimes the secondary packaging also comprises a label or screen with the same or additional information as the primary container. Generally, labels are an integral part of the pharmaceutical product packaging, and they must comply with regulatory requirements, providing clear and accurate information about the product. Labels may include details such as the name of the pharmaceutical compound, the dosage form, instructions for use, storage conditions, expiration date, and other essential information. Labels comprise many different materials. Generally, a label comprises a substrate material, is printed with an ink, optionally comprises an adhesive and eventually a liner. These materials are prone for leaching chemical ingredients, such as volatiles, semi-volatiles, as well as non-volatile compounds, of various nature during the sterilization step, wherein the pharmaceutical product typically is exposed to elevated temperatures, or during shelf-life. Such leaching affects the stability and the quality of the packaged pharmaceutical compound. As set out above, the label of a pharmaceutical product comprises important information. For example, in pharmaceutical application, different products and/or applications are color coded to reduce errors in the hospital. (cf. "Qualitätssicherung Intensiv-/Notfallmedizin: Spritzenetiketten (divi.de)"). Summary of the Invention The need to reduce leachables and the need for intuitive, visible color-coded labels are incompatible. The colored label is therefore only provided on the secondary packaging, while on the primary container only monochrome font is provided. As not all pharmaceutical compounds can be administered directly to a patient, the clinical staff often needs to prepare the administration by transferring the pharmaceutical compound into a medical device like a syringe or another container. As clinical staff is under time pressure a lot, not or uncolored labeled syringes/containers are posing a significant, untraceable thread for the patient. It is therefore an object of the present invention to provide a pharmaceutical product with a higher stability during sterilization and longer lifetime during shelf-life, which does not endanger the patient. It has now surprisingly found out that above-mentioned problem can be achieved by a pharmaceutical product, wherein the pharmaceutical product comprises a container comprising a pharmaceutical compound and/or a medical device suitable for receiving the pharmaceutical compound from the container,an enclosure enclosing the container and/or the medical device, anda label comprised by the enclosure, wherein the enclosure comprises at least one wall enclosing a main cavity,wherein the main cavity is a closed cavity,wherein the cavity comprises the container and/or the medical device. It has been further surprisingly found that above-menti