Orally disintegrating tablet

{
  "publication_number": "US9511028B2",
  "country": "US",
  "kind": "B2",
  "title": "Orally disintegrating tablet",
  "abstract": "The present invention features a tablet containing at least one first material, at least one second material, and at least one pharmaceutically active agent, wherein: (a) the first material is a dielectric water-containing material (i) containing from about 1 to about 5 percent, by weight, of bound water and (ii) having a dielectric loss, when measured at a density of between 0.15 and 0.5 g/cc, of from about 0.05 to about 0.7; and (b) the second material (i) having a water solubility from about 20 to about 400 g per 100 g of water at 25° C., (ii) having a dielectric loss, when measured at a density between 0.5 and 1 g/cc, of less than about 0.05.",
  "claims": [
    "1. A tablet comprising at least one first material, at least one second material, and at least one pharmaceutically active agent, wherein: (a) said first material comprises maltodextrin; (b) said second material is a sugar or sugar alcohol; (c) said tablet comprises from at least 15% to about 45%, by weight, of said first material and from about 20% to about 64%, by weight, of said second material; (d) the combined weight of said at least one first material and said at least one second material comprises at least 60%, by weight, of said tablet; (e) said tablet has a friability of less than about 5%; (f) said tablet has a density less than about 0.8 g/cc; (g) said tablet disintegrates in the mouth when placed on the tongue in less than about 30 seconds; and (h) said tablet comprises less than 5%, by weight, of a polyethylene glycol.",
    "2. A tablet of claim 1, wherein said tablet comprises at least 20%, by weight, of said first material.",
    "3. A tablet of claim 1, wherein said at least one first material has a bulk density of less than 0.2 g/cc.",
    "4. A tablet of claim 1, wherein said at least one second material comprises erythritol.",
    "5. A tablet of claim 1, wherein the combined weight of said at least one first material, said at least one second material, and said at least one pharmaceutically active agent comprises at least 90%, by weight, of said tablet.",
    "6. A tablet of claim 5 wherein said tablet comprises from about 20% to about 45%, by weight, of said first material.",
    "7. A tablet of claim 1, wherein said at least one pharmaceutically active agent are comprised within polymer-coated particles, and said tablet comprises at least 15%, by weight, of said particles.",
    "8. A tablet of claim 1, wherein said tablet does not comprise a polyethylene glycol.",
    "9. A tablet of claim 1, wherein at least 90%, by weight, of the tablet is comprised of material having a melting point greater than 80 C.",
    "10. A tablet of claim 1, wherein the peak penetration resistance at the center of the major face of the tablet is from about 50 to about 600 grams.",
    "11. A tablet of claim 1, wherein said tablet meets the criteria for orally disintegrating tablets as defined by the draft Food & Drug Administration guidance, as published April, 2007.",
    "12. A tablet of claim 1, wherein said tablet comprises from about 39 to about 56%, by weight, of said at least one second material.",
    "13. A tablet of claim 1, wherein said tablet comprises from about 10 to about 40%, by weight, of particles comprising said pharmaceutically active agent.",
    "14. A tablet of claim 1, wherein said tablet disintegrates in the mouth when placed on the tongue in less than about 15 seconds.",
    "15. A tablet of claim 1, wherein the combined weight of said at least one first material, said at least one second material, and said at least one pharmaceutically active agent comprises at least 95%, by weight, of said tablet."
  ],
  "description_excerpt": "Pharmaceuticals intended for oral administration are typically provided in tablet form. Tablets are swallowed whole, chewed in the mouth, or disintegrated in the oral cavity. Soft tablets that either are chewed or dissolve in the mouth are often employed in the administration of pharmaceuticals where it is impractical to provide a tablet for swallowing whole. With chewable tablets, the act of chewing helps to break up the tablet particles as the tablet disintegrates and may increase the rate of absorption by the digestive tract. Soft tablets are also advantageous where it is desirable to make a pharmaceutically active agent available topically in the mouth or throat for both local effects and/or systemic absorption. Soft tablets are also utilized to improve drug administration in pediatric and geriatric patients. Soft tablets designed to disintegrate in the mouth prior to swallowing are particularly useful for improving compliance of pediatric patients.\n\nGenerally, soft tablets are made by compaction of a blend of powdered ingredients and typically include a pharmaceutically active agent, flavoring, and/or binders. The powder blend is typically fed into the cavity of a die of a tablet press and a tablet is formed by applying pressure. Hardness of the resulting tablet is a direct function of the compaction pressure employed and the compatibility of the ingredients in the formulation. A softer tablet, having an easier bite-through, may be prepared by employing reduced compaction pressures.",
  "cpc": [
    "A61K 9/2081",
    "A61K 2300/00",
    "A61K 31/167",
    "A61K 31/426",
    "A61K 31/7004",
    "A61K 9/0056",
    "A61K 9/2018",
    "A61K 9/2095"
  ],
  "ipc": [
    "A61K 31/167",
    "A61K 31/426",
    "A61K 9/20",
    "A61K 31/7004",
    "A61K 9/00"
  ],
  "assignees": [
    "Johnson and Johnson Consumer Inc"
  ],
  "inventors": [
    "Jen-Chi Chen",
    "Kenneth Day",
    "Christopher E. Szymczak"
  ],
  "filing_date": "2013-03-14",
  "publication_date": "2016-12-06",
  "grant_date": "2016-12-06",
  "priority_date": "2012-05-01",
  "application_number": "US-201313803527-A",
  "family_id": "49512694",
  "cited_by_count": 4,
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