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Assignees
Member
VitalisVitalis 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.
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-8652520-B2
Publication Date
2014-02-18
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 document describes a combination tablet that includes a first portion and a second portion. The first portion comprises at least 81 mg aspirin and is formulated to dissolve in the oral cavity of a subject, while the second portion comprises at least 100 mg niacin and is formulated for dissolving in the stomach, intestines, or further distal in the gastrointestinal tract of the subject.
The document further describes a relationship between the oral dissolution of the aspirin portion and niacin-mediated flushing. It provides for reducing niacin flushing by using the aspirin portion in a way that enables aspirin to be released to the subject so as to mitigate flushing associated with niacin, and identifies that aspirin may act through cyclooxygenase inhibition to reduce prostaglandin/prostanoid-mediated flushing.
In addition, the document specifies a niacin-to-aspirin ratio for the tablet. In one embodiment, the ratio of niacin to aspirin in the tablet is equal to or greater than 100/325, and dependent forms further specify higher minimum ratios such as 250/325 and 500/325. The document also describes structural implementations using multiple layers, including an intermediate layer and the possibility of using an enteric coating.
Claims Coverage
The partial content includes two independent claims. Across these claims, the main inventive elements are a two-portion tablet with different dissolution locations for aspirin and niacin, and a specified quantitative niacin-to-aspirin ratio in the tablet.
Two-portion tablet with oral aspirin dissolution and GI niacin dissolution
A tablet comprising at least 81 mg aspirin as a first portion formulated to dissolve in the oral cavity, and at least 100 mg niacin as a second portion formulated for dissolving in the stomach, intestines, or further distal gastrointestinal tract.
Niacin-to-aspirin ratio for the two-portion tablet
A tablet comprising at least 81 mg aspirin in a first portion that dissolves in the oral cavity and at least 100 mg niacin in a second portion that dissolves in the stomach, intestines, or further distal gastrointestinal tract, wherein the ratio of niacin to aspirin is equal to or greater than 100/325.
Overall, the independent claims cover a combination tablet in which aspirin dissolves in the oral cavity while niacin dissolves in the gastrointestinal tract, with an additional constraint on the niacin-to-aspirin ratio for at least one independent formulation.
Stated Advantages
Reduces niacin flushing.
Documented Applications
Lipid modulation, including triglycerides, total cholesterol, LDL, lipoprotein(a), and HDL increases.
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