Process for preparation of dronedarone by removal of hydroxyl group
US-9221778-B2 · Dec 29, 2015 · US
Highly purified pharmaceutical grade tasimelteon
US11566011B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-11566011-B2 |
| Application number | US-202117455308-A |
| Country | US |
| Kind code | B2 |
| Filing date | Nov 17, 2021 |
| Priority date | Feb 12, 2014 |
| Publication date | Jan 31, 2023 |
| Grant date | Jan 31, 2023 |
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Abstract
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A process for preparing a batch of highly purified, pharmaceutical grade tasimelteon comprises analyzing a batch of tasimelteon synthesized under GMP conditions for the presence of one or more identified impurities.
First claim
Opening claim text (preview).
What we claim is: 1. A pharmaceutical composition comprising: tasimelteon that is at least 90.0 area % pure and comprises no more than 0.15 wt % each of one or more impurities selected from a group consisting of: N-(((1R,2R)-2-(2,3-dihydrobenzofuran-4-yl)cyclopropyl)methyl)-3-methylbutanamide (Impurity 1), N-(((1R,2R)-2-(2,3-dihydrobenzofuran-4-yl)cyclopropyl)methyl)-pentanamide (Impurity 2), 1,3-Bis(((1R,2R)-2-(2,3-dihydrobenzofuran-4-yl)cyclopropyl)methyl)urea (Impurity 3), N-(((1R,2R)-2-(benzofuran-4-yl)cyclopropyl)methyl) propionamide (Impurity 4), N-((2-(2,3-dihydrobenzofuran-4-yl)-1-((2-(2,3-dihydrobenzofuran-4-yl)cyclopropyl) (propionamido)methyl) cyclopropyl)methyl)propionamide (Impurity 5), 2-hydroxy-6-(2-(propionamidomethyl)cyclopropyl)phenethyl 2-(2-hydroxyethyl)-3-(2-(propionamidomethyl)cyclopropyl) phenyl carbonate (Impurity 6), and N-(((1R,2R)-2-(3-Oxo-2,3-dihydrobenzofuran-4-yl)cyclopropyl) methyl)propionamide (Impurity 7); and at least one pharmaceutically acceptable excipient. 2. The pharmaceutical composition of claim 1 in pharmaceutical dosage unit form. 3. The pharmaceutical composition of claim 1 , wherein the tasimelteon has been analyzed and shown to comprise no more than 0.15 wt % each of the one or more impurities. 4. A pharmaceutical composition comprising: purified tasimelteon that does not contain any of the following impurities at a concentration greater than about 0.15%:N-(((1R,2R)-2-(2,3-dihydrobenzofuran-4-yl)cyclopropyl)methyl)-3-methylbutanamide (Impurity 1), N-(((1R,2R)-2-(2,3-dihydrobenzofuran-4-yl)cyclopropyl)methyl)-pentanamide (Impurity 2), 1,3-Bis(((1R,2R)-2-(2,3-dihydrobenzofuran-4-yl)cyclopropyl)methyl)urea (Impurity 3), N-(((1R,2R)-2-(benzofuran-4-yl)cyclopropyl)methyl)propionamide (Impurity 4), N-((2-(2,3-dihydrobenzofuran-4-yl)-1-((2-(2,3-dihydrobenzofuran-4-yl)cyclopropyl) (propionamido)methyl) cyclopropyl)methyl)propionamide (Impurity 5), 2-hydroxy-6-(2-(propionamidomethyl)cyclopropyl) phenethyl 2-(2-hydroxyethyl)-3-(2-(propionamidomethyl)cyclopropyl)phenyl carbonate (Impurity 6), and N-(((1R,2R)-2-(3-Oxo-2,3-dihydrobenzofuran-4-yl)cyclopropyl)methyl)propionamide (Impurity 7); and at least one pharmaceutically acceptable excipient. 5. The pharmaceutical composition of claim 4 in pharmaceutical dosage unit form.
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Classifications
- C07D307/81Primary
Radicals substituted by nitrogen atoms not forming part of a nitro radical · CPC title
with only hydrogen atoms, hydrocarbon or substituted hydrocarbon radicals, directly attached to carbon atoms of the hetero ring · CPC title
Hypnotics; Sedatives · CPC title
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Frequently asked questions
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- What does patent US11566011B2 cover?
- A process for preparing a batch of highly purified, pharmaceutical grade tasimelteon comprises analyzing a batch of tasimelteon synthesized under GMP conditions for the presence of one or more identified impurities.
- Who is the assignee on this patent?
- Vanda Pharmaceuticals Inc
- What technology area does this patent fall under?
- Primary CPC classification C07D307/81. Mapped technology areas include Chemistry & Metallurgy.
- When was this patent published?
- Publication date Tue Jan 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) (B2). Legal status and post-grant events are not shown on this page.
- What related patents are in patentsdb?
- We list 8 related publications on this page (citations in our corpus or others sharing the same primary CPC).