Local oral herbal slow release tablets

• US 5,942,244 A
• Filed: 07/31/1997
• Issued: 08/24/1999
• Est. Priority Date: 07/31/1997
• Status: Expired due to Term

• Current Assignee: Farmo-Nat Ltd.
• Original Assignee: Farmo-Nat Ltd.
• Inventors: Friedman, Doron, Friedman, Michael, Levin, Orna, Forman, Yochanan
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): Spear, James M.
• Application Number:
  US08/904,248
• Time in Patent Office: 754 Days
• Field of Search: 424/464, 424/465, 424/435, 424/484, 424/468, 424/469, 424/488, 424/486, 514/960, 514/965
• US Class Current: 424/435
• CPC Class Codes: A61K 35/644 Beeswax; Propolis; Royal jelly; Honey
• CPC Class Codes: A61K 36/185 Magnoliopsida (dicotyledons)
• CPC Class Codes: A61K 36/28 Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
• CPC Class Codes: A61K 36/328 Commiphora, e.g. mecca myrrh or balm of Gilead
• CPC Class Codes: A61K 36/38 Clusiaceae, Hypericaceae or Guttiferae (Hypericum or Mangosteen family), e.g. common St. Johnswort
• CPC Class Codes: A61K 36/53 Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
• CPC Class Codes: A61K 36/534 Mentha (mint)
• CPC Class Codes: A61K 36/537 Salvia (sage)
• CPC Class Codes: A61K 36/54 Lauraceae (Laurel family), e.g. cinnamon or sassafras
• CPC Class Codes: A61K 36/61 Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
• CPC Class Codes: A61K 36/68 Plantaginaceae (Plantain Family)
• CPC Class Codes: A61K 36/74 Rubiaceae (Madder family)
• CPC Class Codes: A61K 36/752 Citrus, e.g. lime, orange or lemon
• CPC Class Codes: A61K 9/0056 Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• CPC Class Codes: A61K 9/2031 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
• CPC Class Codes: A61K 9/2054 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Abstract

A tablet for the local and slow release of herbal medication into the oral cavity of a subject. Also provided is a method of making the tablet and a method of using the tablet. The tablet includes a pharmaceutically effective amount of a herbal medication, a polymeric matrix material such as ethyl cellulose, a release enhancer such as PEG 4000 and a filler such as lactose. The tablet is characterized by long dissolution times of up to 120 minutes.

Claims

1. A tablet for prolonged release of a medication, comprising:

(a) a pharmaceutically effective amount of a herbal medication as the active medication;

(b) a polymeric matrix material;

(c) a release enhancer; and

(d) a filler;

wherein said herbal medication, said polymeric matrix material, said release enhancer and said filler are present in a single layer.

2. The tablet of claim 1, wherein said polymeric matrix material is ethyl cellulose.

3. The tablet of claim 2, wherein said ethyl cellulose is present in an amount of from about 11 percent to about 53 percent, weight per weight.

4. The tablet of claim 1, wherein said release enhancer is polyethylene glycol 4000.

5. The tablet of claim 4, wherein said polyethylene glycol 4000 is present in an amount of from about 8 percent to about 28 percent weight per weight.

6. The tablet of claim 1, wherein said filler is lactose.

7. The tablet of claim 6, wherein said lactose is present in an amount of from about 9 percent to about 57 percent weight per weight.

8. The tablet of claim 1, wherein said herbal medication includes a herbal extract, the tablet further comprising fume silica as an absorbing agent for said herbal extract.

9. The tablet of claim 1, further comprising a coloring agent.

10. The tablet of claim 1, further comprising a flavoring agent.

11. A method of releasing a medication in an oral cavity of a subject, comprising the steps of:

(a) placing a tablet in the oral cavity of the subject, the tablet including;

(i) a pharmaceutically effective amount of a herbal medication as the active medication;

(ii) a polymeric matrix material;

(iii) a release enhancer; and

(iv) a filler;

wherein said herbal medication said polymeric matrix material, said release enhancer and said filler are present in a single layer; and

(b) allowing said tablet to dissolve in the oral cavity of the subject, such that the medication is released.

12. The method of claim 11, wherein said polymeric matrix material is ethyl cellulose.

13. The method of claim 12, wherein said ethyl cellulose is present in an amount of from about 11 percent to about 53 percent, weight per weight.

14. The method of claim 11, wherein said release enhancer is polyethylene glycol 4000.

15. The method of claim 14, wherein said polyethylene glycol 4000 is present in an amount of from about 8 percent to about 28 percent weight per weight.

16. The method of claim 11, wherein said filler is lactose.

17. The method of claim 16, wherein said lactose is present in an amount of from about 9 percent to about 57 percent weight per weight.

18. The method of claim 11, wherein the herbal medication includes a herbal extract, said tablet further including fume silica as an absorbing agent for said herbal extract.

19. The method of claim 11, wherein said tablet further includes a coloring agent.

20. The method of claim 11, wherein said tablet further includes a flavoring agent.

21. A tablet for prolonged release of a medication, comprising:

(a) a pharmaceutically effective amount of a herbal medication as the active medication;

(b) a polymeric matrix material;

(c) a release enhancer; and

(d) a filler;

wherein said herbal medication, said polymeric matrix material, said release enhancer and said filler are present in a single layer and wherein said single layer has a matrix structure.

22. A tablet for prolonged release of a medication, comprising:

(a) a pharmaceutically effective amount of a herbal medication as the active medication;

(b) a polymeric matrix material;

(c) a release enhancer; and

(d) a filler;

wherein said herbal medication, said polymeric matrix material, said release enhancer and said filler are present in a single layer and wherein the tablet is a matrix tablet, thereby obviating the use of a disintegrator.

23. A tablet for prolonged release of a medication, consisting essentially of:

(a) a pharmaceutically effective amount of a herbal medication as the active medication;

(b) a polymeric matrix material;

(c) a release enhancer; and

(d) a filler;

wherein said herbal medication includes a herbal extract, the tablet further comprising fume silica as an absorbing agent for said herbal extract.

24. A tablet for prolonged release of a medication, consisting essentially of:

(a) a pharmaceutically effective amount of a herbal medication as the active medication;

(b) a polymeric matrix material;

(c) a release enhancer; and

(d) a filler.

25. A tablet for prolonged release of a medication, consisting essentially of:

(a) a pharmaceutically effective amount of a herbal medication as the active medication;

(b) a polymeric matrix material;

(c) a release enhancer;

(d) a filler; and

(e) a flavoring agent.

26. A method of releasing a medication in an oral cavity of a subject, comprising the steps of:

(a) placing a tablet in the oral cavity of the subject, the tablet consisting essentially of;

(i) a pharmaceutically effective amount of a herbal medication as the active medication;

(ii) a polymeric matrix material;

(iii) a release enhancer; and

(iv) a filler; and

(b) allowing said tablet to dissolve in the oral cavity of the subject, such that the medication is released.