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Publication Number
US-12558312-B2
Publication Date
2026-02-24
Expiration Date
Abstract
A solid dosage form for oral transmucosal delivery of an active pharmaceutical ingredient (API) is disclosed. Also provided are methods of treating a disease with the solid dosage form.
Core Innovation
The invention describes a solid dosage form for oral transmucosal delivery of an active pharmaceutical ingredient (API), where the dosage form is a film for transmucosal administration. The film includes a therapeutically effective amount of the API together with a water soluble polymer in an amount less than 50% by weight of the dosage form, and further comprises a surfactant, a softener, and a fatty acid.
The surfactant ranges from about 1% to about 10% in the dosage form, and the respective amounts of the surfactant and the fatty acid are selected so that the HLB of their combination ranges from about 8 to about 13. The solid dosage film is thus configured to provide oral transmucosal delivery with the surfactant and fatty acid chosen according to the HLB combination range.
Claims Coverage
The provided independent claim covers 2 inventive features centered on an oral transmucosal solid dosage film and its selected composition and HLB relationship.
HLB-selected surfactant and fatty acid in an oral transmucosal film dosage form
A film solid dosage form for oral transmucosal delivery that includes a therapeutically effective amount of an API, a surfactant, a softener, and a fatty acid, wherein the surfactant ranges from about 1% to about 10% and wherein the respective amounts of the surfactant and the fatty acid are selected so that the HLB of their combination ranges from about 8 to about 13.
Water soluble polymer below 50% by weight in an oral transmucosal film
A film solid dosage form for oral transmucosal delivery comprising a water soluble polymer in an amount less than 50% by weight of the dosage form, in combination with a therapeutically effective amount of an API, a surfactant, a softener, and a fatty acid with the specified HLB combination range.
The claim coverage centers on an oral transmucosal solid dosage film including an API plus a water soluble polymer below 50% by weight, together with a surfactant, softener, and fatty acid, where the surfactant level and the combined surfactant/fatty-acid HLB range are selected to fall within the recited ranges.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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