Direct inkjet fabrication of drug delivery devices

{
  "publication_number": "US9381154B2",
  "country": "US",
  "kind": "B2",
  "title": "Direct inkjet fabrication of drug delivery devices",
  "abstract": "In some aspects of the present application, a method of forming one or more layers of at least a portion of a drug delivery device (DDD) is described. The method can include providing a substrate; providing one or more DDD components that are dissolved or dispersed in one or more pharmaceutically compatible phase change inks; ejecting, by one or more nozzles, a first portion of the one or more pharmaceutically compatible phase change inks to form a first layer on the substrate; and ejecting, by the one or more nozzles, a second portion of the pharmaceutically compatible phase change inks to form a second layer over the first layer.",
  "claims": [
    "1. A method of forming a layer of at least a portion of a drug delivery device (DDD) comprising: providing a substrate; providing a first pharmaceutically compatible phase change ink comprising (a) a color agent, a dye, or a pigment and (b) one or more DDD components dissolved or dispersed therein, wherein the first pharmaceutically compatible phase change ink is a solid at room temperature and has a phase change temperature between 40 and 200° C. and wherein the one or more DDD components include one or more excipients selected from the group consisting of sugar alcohols, zinc stearate, tagatose, sucrose, raffinose, povidone, and triglycerides; heating the pharmaceutically compatible phase change ink above its phase change temperature to form a first fluid ink; ejecting, by one or more nozzles, the first fluid ink onto at least a portion of the surface of the substrate, where it solidifies to form a first layer on the substrate, providing an aqueous or solvent ink, the aqueous or solvent ink comprising one or more DDD components; and ejecting, by one or more nozzles, a portion of the aqueous or solvent ink onto at least a portion of the surface of the substrate and/or onto the first layer; and drying the ejected aqueous or solvent ink to form a second layer.",
    "2. The method of claim 1, wherein the one or more DDD components includes one or more active pharmaceutical ingredients (API).",
    "3. The method of claim 1, wherein the DDD is a tablet.",
    "4. The method of claim 1, further comprising controlling the ejecting by computer-aided design controller.",
    "5. The method of claim 1, wherein the first pharmaceutically compatible phase change ink has a jetting viscosity between 0.5 to 50 cps.",
    "6. The method of claim 1, wherein the drying includes applying heat from a temperature controlled device, wherein the temperature controlled device is selected from the group consisting of: an oven, an apparatus arranged to produce radiation at infrared frequencies, and an apparatus arranged to produce radiation at microwave frequencies.",
    "7. The method of claim 1, wherein the ejecting includes controlling spatial distribution of the one or more DDD components by arranging a predetermined amount of the one or more DDD components at a predetermined location within the DDD.",
    "8. The method of claim 7, wherein the DDD components comprise an active pharmaceutical ingredient (API) and the spatial distribution is controlled to produce a DDD with a spatial distribution of API that has a constant drug release rate.",
    "9. The method of claim 1, wherein the DDD comprises a multilayer shell, the first layer and at least one additional layer form the multilayer shell, and the first layer or the additional layer comprises an active pharmaceutical ingredient (API).",
    "10. The method of claim 9, further comprising forming a buffer region between the first layer and the additional layer to produce a DDD having a predetermined delay release time for the API.",
    "11. The method of claim 9, wherein the DDD comprises a protective coating on the outer surface thereof.",
    "12. The method of claim 1, wherein the DDD is a fast disintegrating tablet.",
    "13. The method of claim 2, wherein the one or more API are selected to treat one or more diseases.",
    "14. The method of claim 1, further comprising forming a liquid active pharmaceutical ingredient (API) section within the DDD.",
    "15. The method of claim 1, wherein the one or more nozzles are part of a three-dimensional printing (3DP) system.",
    "16. The method of claim 1, wherein the DDD comprises a second pharmaceutically compatible phase change ink comprising one or more DDD components."
  ],
  "description_excerpt": "1. Field of the Disclosure\n\nThe present application is directed to a drug delivery devices, and more particularly to a method and system for direct inject fabrication of drug delivery devices.\n\n2. Background of the Disclosure\n\nAbout two third of all prescriptions are in solid dosage forms, and half of these are compressed tablets. Tablets are produced pretty much the same way in pounds or in tons, depending on their medical purposes and newness. There is also a demand for better methodology to achieve more rapid prototyping and time-to-market. The conventional tablets manufacture method is also very limited for creating novel drug delivery devices (DDD) that requires excellent control of microstructure and spatial distribution of API or exicipents inside tablet. Although three-dimensional printing (3DP) provides an alternative approach of manufacturing novel tablet based DDD, the need of powder bed, possible cross contamination, poor mechanical strength, low drug loading are problems of this technology.\n\nCurrently, there are several issues with 3DP manufactured tablets. 3DP requires a powder bed that can lay out a thin and uniform layer of powders. Fine powders are preferable because it gives better binder effect, smoother surfaces, smaller feature size, thinner layer that will eliminate slicing defects such as stair-stepping. However, fine powders are difficult to spread into smooth layers due to their affinity to agglomerate, adhere to walls and poor flowability. These materials property challenges will lead to uneven densification within layers and consequently in the final tablets.",
  "cpc": [
    "A61K 9/0056",
    "A61J 3/07",
    "A61K 9/209",
    "A61K 9/2095",
    "A61K 9/48",
    "A61M 31/00",
    "A61M 37/00",
    "B33Y 30/00",
    "B33Y 80/00"
  ],
  "ipc": [
    "B05C 11/00",
    "A61K 9/00",
    "A61K 9/20",
    "A61K 9/24",
    "C09D 11/34"
  ],
  "assignees": [
    "Xerox Corp"
  ],
  "inventors": [
    "Jing Zhou",
    "Shu Chang"
  ],
  "filing_date": "2011-06-09",
  "publication_date": "2016-07-05",
  "grant_date": "2016-07-05",
  "priority_date": "2011-06-09",
  "application_number": "US-201113156503-A",
  "family_id": "46201450",
  "cited_by_count": 10,
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}