Process for the manufacture of a solid pharmaceutical administration form

{
  "publication_number": "US11229577B2",
  "country": "US",
  "kind": "B2",
  "title": "Process for the manufacture of a solid pharmaceutical administration form",
  "abstract": "The present invention relates to a process for the preparation of a solid pharmaceutical administration form using a 3D printing process as well. The process is a printing process that allows the production of solid pharmaceutical administration forms in a flexible manner and in conformity with the high quality standards required for the production of pharmaceuticals.",
  "claims": [
    "1. A process for the manufacture of a solid pharmaceutical administration form comprising an active ingredient comprising the steps (a) spreading a powder comprising a fusible material and an active ingredient across a manufacturing area to create a powder bed; (b) jet printing a fluid comprising an energy absorbing material onto the powder; (c) irradiating the powder to induce heating of the energy absorbing material in the powder and thereby to induce melting and fusing of the fusible material present in the powder; (d) spreading another layer of the powder onto the surface of unfused and fused powder and subsequently performing step (b) and step (c) again; (e) optionally repeating step (d) as often as needed to build up the solid pharmaceutical administration form; (f) separating the solid pharmaceutical administration form from the powder bed.",
    "2. A process for the manufacture of a solid pharmaceutical administration form comprising an active ingredient comprising the steps (a) spreading a powder comprising an active ingredient across a manufacturing area to create a powder bed; (b) jet printing a fluid comprising a fusible material onto the powder; (c) irradiating the powder to induce melting and fusing of the fusible material present in the powder; (d) spreading another layer of the powder onto the surface of unfused and fused powder and subsequently performing step (b) and step (c) again; (e) optionally repeating step (d) as often as needed to build up the solid pharmaceutical administration form; (f) separating the solid pharmaceutical administration form from the powder bed.",
    "3. A process for the manufacture of a solid pharmaceutical administration form according to claim 1, wherein in step (b) a parting agent is jet printed onto the powder in parallel or subsequently to the jet printing of the energy absorbing material.",
    "4. A process for the manufacture of a solid pharmaceutical administration form according to claim 1, wherein pre-heating is applied in steps (a) and (d) prior to or after spreading the powder.",
    "5. Process according to claim 1, wherein a cooling step is introduced between steps (e) and (f).",
    "6. Process according to claim 1, wherein the irradiating is with irradiation energy that is infrared energy (IR), near-infrared energy (NIR), visible light (VIS), ultraviolet light (UV), microwave or X-radiation.",
    "7. Process according to claim 1, wherein in step (b) the fluid is jet printed more than once in parallel or subsequent jet printings.",
    "8. Process according to claim 1, wherein an active ingredient is jet printed in step (b) and wherein the powder used in steps (a) and (d) does not comprise an active ingredient.",
    "9. Process according to claim 1, characterized in that the powder used in step (a) of the process further comprises an inert material.",
    "10. Process according to claim 1, characterized in that the powder used in step (a) of the process further comprises an additional functional material.",
    "11. Process according to claim 1, wherein the irradiating is with irradiation energy that is infrared energy (IR)."
  ],
  "description_excerpt": "The present invention relates to a process for the preparation of a solid pharmaceutical administration form using a 3D printing process as well. The process is a printing process that allows the production of solid pharmaceutical administration forms in a flexible manner and in conformity with the high quality standards required for the production of pharmaceuticals.\n\nIt is believed that future improvements in disease treatment is driven by point-of-care and home-based diagnostics linked with genetic testing and emerging technologies such as proteomics and metabolomics analysis. This has led to the concept of personalized medicine, which foresees the customization of healthcare to an individual patient.\n\nMedication can be applied to the patient by using different pharmaceutical formulations that are adapted to the desired application method, for example to oral (including buccal or sublingual), rectal, nasal, topical (including buccal, sublingual or transdermal), vaginal or parenteral (including subcutaneous, intramuscular, intravenous or intradermal) application. In general, oral application is preferred as such application is easy and convenient and does not cause any harm that may be associated with other application methods such as parenteral application.\n\nPharmaceutical formulations usable for oral administration are, for example, capsules or tablets; powders or granules; solutions or suspensions in aqueous or non-aqueous liquids; edible foams or foam foods; or oil-in-water liquid emulsions or water-in-oil liquid emulsions.",
  "cpc": [
    "A61J 3/10",
    "A61K 9/2095",
    "B29C 64/165",
    "B29C 64/209",
    "B29C 64/264",
    "B29C 64/30",
    "B29L 2031/753",
    "B33Y 10/00",
    "B33Y 30/00",
    "B33Y 40/00",
    "B33Y 80/00"
  ],
  "ipc": [
    "A61J 3/10",
    "B29C 64/165",
    "B29C 64/209",
    "B33Y 10/00",
    "B33Y 80/00",
    "A61K 9/20",
    "B33Y 30/00"
  ],
  "assignees": [
    "Merck Patent GmbH"
  ],
  "inventors": [
    "Stefan Schiller",
    "Andrea Hanefeld",
    "Gerhard Jonschker"
  ],
  "filing_date": "2017-09-08",
  "publication_date": "2022-01-25",
  "grant_date": "2022-01-25",
  "priority_date": "2016-09-09",
  "application_number": "US-201716331554-A",
  "family_id": "56926030",
  "cited_by_count": 4,
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}