Tablets having discontinuous coated regions

Patent metadata

Field	Value
Publication number	US-2019022011-A1
Application number	US-201715652315-A
Country	US
Kind code	A1
Filing date	Jul 18, 2017
Priority date	Jul 19, 2016
Publication date	Jan 24, 2019
Grant date	—

Abstract

A dosage form comprising a tablet core and one or more discontinuous coated regions in various configurations on the surface of the dosage form is disclosed. A method for making the dosage form is also disclosed.

First claim

1 . A dosage form comprising a substrate and at least one discontinuous coated region positioned on a surface of the substrate, wherein the at least one discontinuous coated region is positioned longitudinally on the substrate, wherein said at least one discontinuous coated region confers an observable benefit to its user.

2 . The dosage form of claim 1 , wherein said at least one discontinuous coated region affects at least one sense of said user, wherein said at least one sense is selected from group consisting of hearing, sight, touch, smell, and taste.

3 . The dosage form of claim 1 , wherein said at least one discontinuous coated region comprises at least one agent selected from the group consisting of sensate, salivant, flavor and sweetener.

4 . The dosage form of claim 1 , wherein said at least one discontinuous coated region aids swallowability of said dosage form.

5 . The dosage form of claim 1 , wherein said at least one discontinuous coated region comprises at least one lubricious material.

6 . The dosage form of claim 1 , wherein said at least one discontinuous coated region comprises a visual selected from the group consisting of configuration, color and marking that conveys attributes of the dosage form to said user.

7 . The dosage form of claim 1 , wherein at least two discontinuous coated regions are positioned on the surface of the substrate.

8 . The dosage form of claim 1 , wherein the substrate is cylindrical in shape.

9 . The dosage form of claim 8 , wherein the at least one discontinuous coated region concentrically surrounds the surface of substrate.

10 . The dosage form of claim 9 , wherein the substrate is angled at one end, and wherein the discontinuous coated region covers a portion of the angled end.

11 . (canceled)

12 . The dosage form of claim 1 , wherein the substrate comprises at least one active agent.

13 . The dosage form of claim 1 , wherein at least three to at least ten discontinuous coated regions are positioned on the surface of the substrate.

14 . A method of making a dosage form, comprising:
(a) preparing a substrate; and (b) positioning a discontinuous coated region on a surface of the substrate.

15 . The method of claim 14 , wherein the at least one discontinuous coated region is extrusion coated on the substrate.

16 . The method of claim 14 , wherein the at least one discontinuous coated region is screen coated on the substrate.

17 . The method of claim 14 , wherein the at least one discontinuous coated region is printed on the substrate.

18 . The method of claim 14 , wherein the at least one discontinuous coated region is brush coated on the substrate.

19 . The method of claim 14 , wherein the at least one discontinuous coated region is sprayed on the substrate.

20 . The method of claim 14 , wherein the at least one discontinuous coated region is painted on the substrate.

21 . The method of claim 14 , wherein the at least one discontinuous coated region is 3D printed on the substrate.

22 . The method of claim 14 , wherein the at least one discontinuous coated region comprises a material selected from the group consisting of polymers, meltable carbohydrates, fats, fatty acid esters, phospholipids, waxes, and gelling material,
wherein the fats are selected from the group consisting of hydrogenated vegetable oils selected from cocoa butter, hydrogenated palm kernel oil, hydrogenated cottonseed oil, hydrogenated sunflower oil, and hydrogenated soybean oil; and free fatty acids and their salts. wherein the fatty acid esters are selected from the group consisting of sucrose fatty acid esters, mono, di, and triglycerides, glyceryl behenate, glyceryl palmitostearate, glyceryl monostearate, glyceryl tristearate, glyceryl trilaurylate, glyceryl myristate, GLYCOWAX-932, lauroyl macrogol-32 glycerides, and stearoyl macrogol-32 glycerides, wherein the phospholipids are selected from the group consisting of phosphotidyl choline, phosphotidyl serene, phosphotidyl enositol, and phosphotidic acid, wherein the waxes are selected from the group consisting of camauba wax, spermaceti wax, beeswax, candelilla wax, shellac wax, microcrystalline wax, and paraffin wax, wherein the polymers are selected from the group consisting of polyethylene oxide, polyvinyl acetate and polycapralactone; and water soluble film forming polymers selected from hydroxypropyl cellulose, hypromellose, methylcellulose, pullulan, modified starches, and hydroxyethylcellulose, wherein the carbohydrate is selected from the group consisting of polysaccharides selected from polyfructose, polydextrose, inulin, hydrogen starch hydrosylate; isomalt; and sugar alcohols selected from as xylitol, sorbitol erythritol and mixtures thereof, and wherein the gelling material is selected from the group consisting of gelatin, pectin, gellan gum, carrageenan, and xanthan gum.

23 . The dosage form of claim 1 , wherein the at least one discontinuous coated region comprises a tape.

24 . The dosage form of claim 1 , wherein the at least one discontinuous coated region comprises a preformed discontinuous coated region.

25 . The dosage form of claim 1 , wherein the at least one discontinuous coated region comprises an active agent.

26 . The dosage form of claim 1 , wherein the substrate and the at least one discontinuous coated region each comprise an active agent.

27 . The dosage form of claim 26 , wherein the substrate releases active agent at a rate different from the release rate of active agent from the at least one discontinuous coated region.

28 . The dosage form of claim 26 , wherein the active agent in the substrate is different from the active agent in the at least one discontinuous coated region.

29 . The dosage form of claim 26 , wherein the active agent in the substrate is chemically incompatible with the active agent in the at least one discontinuous coated region.

30 . The dosage form of claim 1 , wherein the at least one discontinuous coated region comprises at least one product selection indicia integrated with the at least one discontinuous coated region, wherein said product selection indicia assists a consumer with determining whether or not the product is appropriate for the consumer's purchase or use.

31 . The dosage form of claim 30 , wherein the at least one product selection indicia is selected from the group consisting of an alphanumeric graphic, a pictorial graphic, a color, brand, logo, color, name of drug, location of symptoms, symptoms treated, time of day for use, drowsy/non-drowsy, form, flavor and combinations thereof.

32 . The dosage form of claim 30 , wherein said dosage form comprises at least two product selection indicia integrated with the at least one discontinuous coated region.

33 . The dosage form of claim 30 , wherein said dosage form comprises from two to ten product selection indicia integrated with the at least one discontinuous coated region.

34 . An apparatus for applying a circumferential discontinuous coated region on a surface of a tablet-shaped substrate, comprising:
a fixture, wherein said fixture contains movable pins, wherein said movable pins engage features on opposing surfaces of said tablet-shaped substrate; a movable surface in close proximity to said f

Assignees

• Johnson & Johnson Consumer Inc

Inventors

• Sowden Harry
• Mcnally Gerard
• Lee Der-Yang

Classifications

• B05D1/265

  Extrusion coatings · CPC title

• B05C1/003

  incorporating means for heating or cooling the liquid or other fluent material (B05C11/1042 takes precedence) · CPC title

• B05D2258/02

  The objects being coated one after the other · CPC title

• B05D1/40

  Distributing applied liquids or other fluent materials by members moving relatively to surface · CPC title

• A61K9/0053

  Mouth and digestive tract, i.e. intraoral and peroral administration · CPC title