Solid forms of 2-(tert-butylamino)-4-((1R,3R,4R)-3-hydroxy-4-methylcyclohexylamino)-pyrimidine-5-carboxamide, compositions thereof and methods of their use
US-9365524-B2 · Jun 14, 2016 · US
Formulations of 2-(tert-butylamino)-4-((1R,3R,4R)-3-hydroxy-4-Methylcyclohexylamino)-pyrimidine-5-carboxamide
US9796685B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-9796685-B2 |
| Application number | US-201514969750-A |
| Country | US |
| Kind code | B2 |
| Filing date | Dec 15, 2015 |
| Priority date | Dec 16, 2014 |
| Publication date | Oct 24, 2017 |
| Grant date | Oct 24, 2017 |
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- Title
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- Abstract
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Abstract
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Provided are pharmaceutical compositions and dosage forms of 2-(tert-butylamino)-4-((1R,3R,4R)-3-hydroxy-4-methylcyclohexylamino)-pyrimidine-5-carboxamide, or a pharmaceutically acceptable stereoisomer, tautomer, solid form, polymorph, salt, hydrate, clathrate, or solvate thereof. Also provided are methods of treating, managing, or preventing various disorders, such as diseases or disorders treatable or preventable by inhibition of a JNK pathway in mammals using such pharmaceutical compositions or dosage forms. Further provided are salts of 2-(tert-butylamino)-4-((1R,3R,4R)-3-hydroxy-4-methylcyclohexylamino)-pyrimidine-5-carboxamide and methods of preparation of such salts.
First claim
Opening claim text (preview).
What is claimed is: 1. A pharmaceutical composition comprising about 20-40% by weight of 2-(tert-butylamino)-4-((1R,3R,4R)-3-hydroxy-4-methylcyclohexylamino)-pyrimidine-5-carboxamide or a pharmaceutically acceptable salt, stereoisomer, solvate, hydrate, isotopologue or solid form thereof, about 30-50% by weight of microcrystalline cellulose, about 20-40% by weight of mannitol, about 1-10% by weight of carboxymethyl cellulose, about 1-10% by weight of hydroxypropyl methycellulose and about 0.1-2% by weight of magnesium stearate. 2. A pharmaceutical composition comprising about 28.57% by weight of 2-(tert-butylamino)-4-((1R,3R,4R)-3-hydroxy-4-methylcyclohexylamino)-pyrimidine-5-carboxamide or a pharmaceutically acceptable salt, stereoisomer, solvate, hydrate, isotopologue or solid form thereof, about 37.43% by weight of microcrystalline cellulose, about 26% by weight of mannitol, about 4% by weight of carboxymethyl cellulose, about 3% by weight of hydroxypropyl methycellulose and about 1% by weight of magnesium stearate. 3. A pharmaceutical composition comprising about 20-40% by weight of 2-(tert-butylamino)-4-((1R,3R,4R)-3-hydroxy-4-methylcyclohexylamino)-pyrimidine-5-carboxamide or a pharmaceutically acceptable salt, stereoisomer, solvate, hydrate, isotopologue or solid form thereof, about 20-40% by weight of microcrystalline cellulose, about 20-40% by weight of mannitol, about 1-20% by weight of carboxymethyl cellulose, about 1-10% by weight of hydroxypropyl methycellulose and about 0.1-2% by weight of magnesium stearate. 4. A pharmaceutical composition comprising about 28.57% by weight of 2-(tert-butylamino)-4-((1R,3R,4R)-3-hydroxy-4-methylcyclohexylamino)-pyrimidine-5-carboxamide or a pharmaceutically acceptable salt, stereoisomer, solvate, hydrate, isotopologue or solid form thereof, about 33.43% by weight of microcrystalline cellulose, about 26% by weight of mannitol, about 8% by weight of carboxymethyl cellulose, about 3% by weight of hydroxypropyl methycellulose and about 1% by weight of magnesium stearate. 5. A pharmaceutical composition comprising about 28.57% by weight of 2-(tert-butylamino)-4-((1R,3R,4R)-3-hydroxy-4-methylcyclohexylamino)-pyrimidine-5-carboxamide or a pharmaceutically acceptable salt, stereoisomer, solvate, hydrate, isotopologue or solid form thereof, about 31.93% by weight of microcrystalline cellulose, about 26% by weight of mannitol, about 8% by weight of carboxymethyl cellulose, about 4.5% by weight of hydroxypropyl methycellulose and about 1% by weight of magnesium stearate. 6. A pharmaceutical composition comprising about 20-40% by weight of 2-(tert-butylamino)-4-((1R,3R,4R)-3-hydroxy-4-methylcyclohexylamino)-pyrimidine-5-carboxamide or a pharmaceutically acceptable salt, stereoisomer, solvate, hydrate, isotopologue or solid form thereof, about 20-50% by weight of microcrystalline cellulose, about 20-40% by weight of mannitol, about 1-10% by weight of carboxymethyl cellulose, about 1-10% by weight of hydroxypropyl methycellulose and about 0.1-2% by weight of magnesium stearate. 7. A pharmaceutical composition comprising about 28.57% by weight of 2-(tert-butylamino)-4-((1R,3R,4R)-3-hydroxy-4-methylcyclohexylamino)-pyrimidine-5-carboxamide or a pharmaceutically acceptable salt, stereoisomer, solvate, hydrate, isotopologue or solid form thereof, about 35.93% by weight of microcrystalline cellulose, about 26% by weight of mannitol, about 4% by weight of carboxymethyl cellulose, about 4.5% by weight of hydroxypropyl methycellulose and about 1% by weight of magnesium stearate.
Assignees
Inventors
Classifications
for hyperglycaemia, e.g. antidiabetics · CPC title
Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 · CPC title
Immunomodulators · CPC title
Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] · CPC title
- A61K31/505Primary
Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim · CPC title
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- What does patent US9796685B2 cover?
- Provided are pharmaceutical compositions and dosage forms of 2-(tert-butylamino)-4-((1R,3R,4R)-3-hydroxy-4-methylcyclohexylamino)-pyrimidine-5-carboxamide, or a pharmaceutically acceptable stereoisomer, tautomer, solid form, polymorph, salt, hydrate, clathrate, or solvate thereof. Also provided are methods of treating, managing, or preventing various disorders, such as diseases or disorders tre…
- Who is the assignee on this patent?
- Signal Pharm Llc
- What technology area does this patent fall under?
- Primary CPC classification A61K31/505. Mapped technology areas include Human Necessities.
- When was this patent published?
- Publication date Tue Oct 24 2017 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 4 related publications on this page (citations in our corpus or others sharing the same primary CPC).