ANTI-APPETITE ADHESIVE COMPOSITIONS

• US 20120015021A1
• Filed: 07/13/2010
• Published: 01/19/2012
• Est. Priority Date: 07/13/2010
• Status: Abandoned Application

• Current Assignee: Axiomedic Limited
• Original Assignee: Axiomedic Limited
• Inventors: Mizrahi, Boaz, Brama, Benny, Domb, Abraham J.
• Application Number:
  US12/835,591
• Publication Number:
  US 20120015021A1
• Time in Patent Office: Days
• US Class Current: 424/435
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 36/258 Panax (ginseng)
• CPC Class Codes: A61K 36/27 Asclepiadaceae (Milkweed family), e.g. hoya
• CPC Class Codes: A61K 36/48 Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
• CPC Class Codes: A61K 36/82 Theaceae (Tea family), e.g. camellia
• CPC Class Codes: A61K 36/906 Zingiberaceae (Ginger family)
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• CPC Class Codes: A61K 9/2086 Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat active cores with a complete drug-free outer coat A61K9/28
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00

Abstract

Compositions for appetite suppression and methods of making and using thereof are disclosed herein. The compositions are typically in the form of a tablet, such as a single or multi-layer sticker tablet. The compositions adhere to a buccal surface or mucosal surface in the oral cavity for at least 15 minutes, preferably for at least 30 minutes. In a preferred embodiment, the compositions contain herbal agents that are anti-appetite agents. The composition is generally effective for suppressing appetite for a time period ranging from at least 30 minutes up to eight hours following administration to the buccal or oral mucosa.

Claims

1. A bioadhesive sticker tablet for appetite suppression in a patient comprising a pharmaceutically acceptable bioadhesive carrier,

wherein the tablet, upon application to a mucosal surface, adheres to the mucosal tissue for at least 15 minutes;

and

wherein the tablet does not completely dissolve prior to about 15 minutes following application to a mucosal surface; and

wherein the tablet contains a therapeutically effective amount of an herbal anti-appetite agent that suppresses appetite for at least 15 minutes following administration to the oral mucosa.

2. The tablet of claim 1, wherein the tablet is in the form of a single layer tablet.

3. The tablet of claim 1, wherein the tablet is in the form of a double layer tablet.

4. The tablet of claim 3, wherein the first layer and the second layer of the double layer tablet comprise one or more bioadhesive materials.

5. The tablet of claim 1, wherein the tablet dissolves following application to the mucosal surface over a period of time from about 15 minutes to about eight hours.

6. The tablet of claim 1, wherein the anti-appetite agent is an herbal agent.

7. The tablet of claim 6, wherein the anti-appetite agent is selected from the group consisting of Hoodia gordonii, green tea, alfalfa, ginger, ginseng, and combinations thereof.

8. The tablet of claim 1, wherein the anti-appetite agent is present in a concentration of 3 to 30% by weight of the tablet.

9. The tablet of claim 8, wherein the anti-appetite agent is present in a concentration of 20 to 30% by weight of the tablet.

10. The tablet of claim 8, wherein the anti-appetite agent is present in a concentration of 3 to 12% by weight of the tablet.

11. The tablet of claim 1, further comprising a flavoring agent, a binder, or a buffering agent, or a combination thereof.

12. The tablet of claim 1, wherein a mucoadhesive is present in at least five percent by weight.

13. The tablet of claim 1, wherein the mucoadhesive is selected from the group consisting of copolymers of acrylic or methacrylic acid;

esterified polyacrylic acid polymers;

maleic acid copolymers;

polysaccharides;

hydrocolloid gels prepared from polysaccharides extracted from Fronia elephantum, Sapindus trifoliatus, Kunjac, and the cashew tree;

cellulose;

cellulose derivatives;

or combinations thereof.

14. The tablet of claim 12, wherein the mucoadhesive comprises a polyacrylic acid polymer crosslinked with a polyalkenyl polyether and hydroxypropyl cellulose.

15. The tablet of claim 1 having a mass of from about 50 mg to about 500 mg.

16. The tablet of claim 1 having a surface area from about 0.4 cm² to about 30 cm² or has a diameter of up to three cm.

18. The method of claim 16, wherein the tablet is placed on the palate or the cheek.

19. The method of claim 16, wherein the tablet adheres to the buccal or oral mucosa for between about 15 minutes and about eight hours.

20. The method of claim 16, wherein the tablet dissolves following application to the mucosal surface over a period of time ranging from about 15 minutes to about eight hours.

21. The method of claim 16, wherein the mucoadhesive is selected from the group consisting of copolymers of acrylic or methacrylic acid;

esterified polyacrylic acid polymers;

maleic acid copolymers;

polysaccharides;

hydrocolloid gels prepared from polysaccharides extracted from Fronia elephantum, Sapindus trifoliatus, Kunjac, and the cashew tree;

cellulose;

cellulose derivatives;

or combinations thereof.

17. A method for suppressing appetite in a patient in need thereof, comprising:

administering on the buccal or oral mucosa of the mouth of the patient an adhesive tablet comprising an herbal agent that is an anti-appetite agent, effective to adhere the tablet to the mucosa for at least about 15 minutes following administration,

wherein the tablet does not completely dissolve prior to about 15 minutes following administration, and

wherein appetite is suppressed for at least about 15 minutes following administration

22. The method of claim 23, wherein the mucoadhesive comprises a polyacrylic acid polymer crosslinked with a polyalkenyl polyether and hydroxypropyl cellulose.

23. The method of claim 17, wherein appetite is suppressed for a period of time between 15 minutes and eight hours following administration to the oral mucosa.