Non-pulsatile prolonged-release betahistine oral solid compositions
US11433058B2 · kind B2 · utility
Assignee
Inventors
Key dates
| Filing date | Jul 16, 2018 |
| Grant date | Sep 6, 2022 |
| Priority date | — |
| Expiry date | Jan 26, 2039 |
Classification
- Technology area (CPC A)Human Necessities
- CPC primaryA61K9/2095
- WIPO fieldPharmaceuticals
- WIPO sectorChemistry
Abstract
An oral solid non-pulsatile 24 hours prolonged-release composition including an amount of betahistine, or of a pharmaceutically acceptable salt thereof, equivalent to 48 mg of betahistine dihydrochloride, together with one or more pharmaceutically acceptable excipients or carriers, wherein the composition exhibits a dissolution profile according to which: up to 30% by weight of betahistine is dissolved in 1 hour; from 35% to 45% by weight of betahistine is dissolved in 2 hours; from 46% to 60% by weight of betahistine is dissolved in 4 hours; from 61% to 80% by weight of betahistine is dissolved in 8 hours; from 81% to 97% by weight of betahistine is dissolved in 16 hours; and from 98% to 100% by weight of betahistine is dissolved in 24 hours. It also relates to the treatment of a vestibular disease or condition, more particularly in the treatment of Ménière's disease.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.