PHARMACEUTICAL ARTICLES COATED WITH LUBRICIOUS COATINGS

• US 20100124568A1
• Filed: 11/20/2008
• Published: 05/20/2010
• Est. Priority Date: 11/20/2008
• Status: Abandoned Application

• Current Assignee: Med-El Incorporated
• Original Assignee: Med-El Incorporated
• Inventors: Sohn, Michael, Eramo, Lincoln, Jackson, Brad
• Application Number:
  US12/274,965
• Publication Number:
  US 20100124568A1
• Time in Patent Office: Days
• US Class Current: 424/465
• CPC Class Codes: A61K 9/284 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
• CPC Class Codes: A61K 9/288 Compounds of unknown constitution, e.g. material from plants or animals oils, fats, waxes, shellac A61K9/282

Abstract

The invention provides pills and tablets having lubricious coating deposited over the outer surface of the pills and the tablets. The coating comprises at least one hydrophilic polymer and at least one natural product, such as a natural polymer, a natural resin and/or a natural gum.

Claims

1. A pharmaceutical article, comprising:

(a) a substrate comprising a therapeutically active agent; and

(b) a lubricious coating deposited over the substrate,

wherein the article is adapted for swallowing by a mammalian subject, and wherein the coating is formed of a polymeric composition, comprising;

(1) at least one hydrophilic polymer; and

(2) at least one natural product derived directly from plants or animals,

wherein the lubriciousness of the coating is between 2 and 10 times better than the lubriciousness of a standard pill coating.

2. The pharmaceutical article of claim 1, wherein the mass ratio between the hydrophilic polymer(s) and the natural product(s) is between about 1:

1 and about 99;

1.

3. The pharmaceutical article of claim 2, wherein the mass ratio is between about 4:

1 and about 7;

1.

4. The pharmaceutical article of claim 1, wherein the natural product is selected from the group consisting of a natural polymer, a natural resin, a natural gum, and a combination thereof.

5. The pharmaceutical article of claim 4, wherein the natural product is a natural polymer selected from the group consisting of nucleic acids, proteins, polysaccharides and polycarbohydrates.

6. The pharmaceutical article of claim 4, wherein the natural product is a natural resin selected from the group consisting of shellac, sandarach, guaiacum, storax, latex of rubber trees, scammony, bush resin, dammar gum, acaroid resin, asafetida, camphor, cannabis resin, amber, copal, dammar, and mastic.

7. The pharmaceutical article of claim 4, wherein the natural product is a natural gum selected from the group consisting of agar, carrageenan, β

-glucan, chicle gum, okra, galbanum resin, dammar gum, gellan and xanthan gums, glucomannan, guar gum, gum arabic, gum ghatti, gum tragacanth, and karaya gum.

8. The pharmaceutical article of claim 1, wherein the hydrophilic polymer has a solubility parameter that is higher than about 8.5 (cal/cm³)^1/2.

9. The pharmaceutical article of claim 1, wherein the hydrophilic polymer is selected from the group consisting of a poly(alkylene glycol), an alkoxy poly(alkylene glycol), poly(vinyl alcohol), and poly(N-vinyl lactam).

10. The pharmaceutical article of claim 9, wherein the hydrophilic polymer is selected from the group consisting of poly(ethylene oxide), poly(propylene glycol), and poly(vinyl pyrrolidone).

11. The pharmaceutical article of claim 9, wherein the hydrophilic polymer is poly(ethylene oxide).

12. The pharmaceutical article of claim 1, wherein the natural product is refined, purified, processed, or condensed without chemically altering the structure thereof.

13. The pharmaceutical article of claim 1, wherein the natural product is a product of animal secretion or is obtained from animal parts.

14. The pharmaceutical article of claim 1, wherein the natural product is a plant extract or is obtained from actual plant parts.

15. The pharmaceutical article of claim 1, wherein the polymeric composition forming the lubricious coating further comprises at least one crossed-linked polymer forming an interpenetrating polymer network or a hydrogel.

16. The pharmaceutical article of claim 15, wherein the cross-linked polymer is formed by polymerization of a monomer selected from the group consisting of an acrylate, a methacrylate, an epoxy-acrylate, and an isocyanate.

17. The pharmaceutical article of claim 16, wherein the acrylate is selected from the group consisting of a monomer having least two acrylate groups.

18. The pharmaceutical article of claim 16, wherein the methacrylate is selected from the group consisting of a monomer having least two methacrylate groups.

19. The pharmaceutical article of claim 1, wherein the mammalian subject is a human selected from the group consisting of an adolescent, a child, an infant, and a geriatric patient.

20. The pharmaceutical article of claim 19, wherein the human is suffering from the gag reflex.

21. The pharmaceutical article of claim 1, wherein the administration of the article is accomplished without use of water.

22. The pharmaceutical article of claim 1, wherein the article is selected from a group consisting of a pill and a tablet.

23. The pharmaceutical article of claim 22, wherein the pill has the shape selected from the group consisting of spherical, elliptical, oblate spherical, prolate spherical, pyramidal, conical, ogival, right circular cylindrical, discal, plano-convex, lenticular, cubical, and cuboidal shape.

24. The pharmaceutical article of claim 1, wherein the pharmaceutical article is selected from the group consisting of synthetic drugs, naturally occurring remedies, prescription drugs, over-the-counter drugs, generic drugs, brand-name drugs, vitamins, minerals, nutritional supplements, homeopathic remedies, or herbal remedies.

25. A method for manufacturing the pharmaceutical article according to claim 1, comprising forming the substrate and depositing the polymer-containing composition over the outer surface of the substrate to form the lubricious coating thereby.