Combination tablet with chewable outer layer

Inventors

Habboushe, Joseph Peter

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Assignees

Vitalis LLC

Member
Vitalis
Vitalis

Vitalis develops infrastructure for integrating, resolving, and analyzing health data streams from multiple sources such as wearables, sensors, labs, and medical records to create a unified longitudinal health record. Initially focused on brain health and cumulative exposure monitoring, Vitalis emphasizes consent-driven, secure, and research-ready data practices. The platform is vendor-agnostic, supporting data portability, user privacy, and adaptability to high-stakes operational environments.

Publication Number

US-8404275-B2

Patent

Publication Date

2013-03-26

Expiration Date


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.

Core Innovation

The invention relates to a tablet comprising an outer portion and an inner portion, where the outer portion comprises at least 81 mg aspirin and is formulated to dissolve in the oral cavity of a subject and release the aspirin across the oral mucosa of the subject. The inner portion comprises at least 100 mg niacin and is harder than the outer portion, and is formulated for dissolving in stomach, intestines, or further distal in the gastrointestinal tract of the subject.

The different physical portions establish different dissolution locations, with aspirin delivered across the oral mucosa while niacin is delivered by dissolving in the gastrointestinal tract. The tablet further defines a ratio of niacin to aspirin, including an equal to or greater than constraint, to set the composition balance between the two therapeutic components.

Claims Coverage

The document includes two independent claims covering a two-portion tablet with an aspirin-containing outer portion for oral cavity/oral mucosa dissolution and a niacin-containing harder inner portion for dissolution in the stomach, intestines, or further distal gastrointestinal tract, with one claim adding a defined niacin-to-aspirin ratio limitation.

Outer aspirin portion dissolving in oral cavity and releasing across oral mucosa with harder inner niacin portion for gi dissolution

A tablet comprising an outer portion comprising at least 81 mg aspirin, wherein the outer portion is formulated to dissolve in the oral cavity and release the aspirin across the oral mucosa, and an inner portion comprising at least 100 mg niacin, 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.

Niacin-to-aspirin ratio constraint for the outer aspirin portion and harder inner niacin portion

A tablet comprising an outer portion comprising at least 81 mg aspirin and an inner portion comprising at least 100 mg niacin, wherein the outer portion is formulated to dissolve in the oral cavity and release the aspirin across the oral mucosa and the inner portion is harder than the outer portion and is formulated for dissolving in stomach, intestines, or further distal in the gastrointestinal tract, wherein the ratio of niacin to aspirin in the tablet is equal to or greater than 100/325.

Overall, the independent claim set defines a structured tablet with location-specific dissolution and delivery behavior for aspirin and niacin, and one independent claim additionally requires a niacin-to-aspirin ratio equal to or greater than 100/325.

Stated Advantages

Documented Applications

No documented applications found

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