Combination tablet with chewable outer layer

• US 8,404,275 B2
• Filed: 12/23/2009
• Issued: 03/26/2013
• Est. Priority Date: 07/01/2007
• Status: Active Grant

• Current Assignee: Vitalis LLC
• Original Assignee: Vitalis LLC
• Inventors: Habboushe, Joseph Peter
• Primary Examiner(s): Wax, Robert A
• Assistant Examiner(s): Tcherkasskaya, Olga V
• Application Number:
  US12/646,395
• Publication Number:
  US 20100166810A1
• Time in Patent Office: 1,189 Days
• Field of Search: None
• US Class Current: 424/474
• CPC Class Codes: A61K 31/455 Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
• CPC Class Codes: A61K 31/616 by carboxylic acids, e.g. acetylsalicylic acid
• 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 9/20 Pills, tablets, discs, rods A61K9/0004, A61K9/0007, A61K9/0056, A61K9/0065 take precedence; for reconstitution of a drink A61K9/0095
• CPC Class Codes: A61K 9/209 containing drug in at least two layers or in the core and in at least one outer layer
• CPC Class Codes: A61K 9/28 Dragees; Coated pills or tablets , e.g. with film or compression coating A61K9/2072 takes precedence, e.g. partially coated tablets A61K9/2072, coated multilayer tablets A61K9/2086, tablets with drug-coated core A61K9/209
• CPC Class Codes: A61P 7/00 Drugs for disorders of the blood or the extracellular fluid

Abstract

A pharmaceutical composition in the form of a combination tablet is described. The tablet has a rapidly absorbed component that enters the circulation by traversing the buccal mucosa, oral mucosa and combinations thereof, and a more slowly absorbed component that is swallowed. The therapeutic agent in the swallowed portion is absorbed across the gastric mucosa. The combination tablet may be modified, by varying the specific combinations of excipients, fillers, and the like to effect distinct release rates. In addition, the rapid and slow components may have identical or different therapeutic agents depending on the application to a specific medical condition. One embodiment of the combination tablet includes a prostaglandin inhibitor in the rapidly absorbed component in order to mitigate the side effects of immediate release niacin that is in the slow absorbing component. Such combination compositions will increase patient compliance with various dosing regimens due to the resultant decrease in the number of tablets that a patient would need to take on a daily basis.

Claims

1. A tablet comprising:

(a) an outer portion comprising at least 81 mg aspirin; and

(b) an inner portion comprising at least 100 mg niacin,

wherein the outer portion is formulated to dissolve in the oral cavity of a subject and to release the aspirin across the oral mucosa of the subject, and wherein the inner portion is harder than the outer portion and is formulated for dissolving in stomach, intestines, or further distal in the gastrointestinal tract of the subject.

2. The tablet of claim 1, wherein the outer potion is flavored or sweetened.

3. The tablet of claim 1, wherein the outer portion comprises a water soluble sugar or sugar substitute.

4. The tablet of claim 1, wherein the outer portion is surrounded by a thin shell.

5. The tablet of claim 4, wherein the outer portion comprises liquid, gel or powder.

6. The tablet of claim 1, further comprising an intermediate layer between the outer and inner portions.

7. The tablet of claim 6, wherein the intermediate layer comprises enteric coating.

8. The tablet of claim 1, wherein the outer portion further comprises an anti-flush agent that is not aspirin.

9. The tablet of claim 8, wherein the anti-flush agent is selected from a cylcooxygenase inhibitor or a non-steroidal anti-inflammatory drug (NSAID).

11. The tablet of claim 9, wherein the ratio of niacin to aspirin in the tablet is equal to or greater than 250/325.

12. The tablet of claim 9, wherein the ratio of niacin to aspirin in the tablet is equal to or greater than 500/325.

10. A tablet comprising:

(a) an outer portion comprising at least 81 mg aspirin; and

(b) an inner portion comprising at least 100 mg niacin,

wherein the outer portion is formulated to dissolve in the oral cavity of a subject and to release the aspirin across the oral mucosa of the subject, and wherein the inner portion is harder than the outer portion and is formulated for dissolving in stomach, intestines, or further distal in the gastrointestinal tract of the subject, and

wherein the ratio of niacin to aspirin in the tablet is equal to or greater than 100/325.