Pharmaceutical compositions of cytidine analogs and methods of use thereof
US-9393255-B2 · Jul 19, 2016 · US
Formulation of 5-azacytidine
US9765108B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-9765108-B2 |
| Application number | US-201314441517-A |
| Country | US |
| Kind code | B2 |
| Filing date | Nov 8, 2013 |
| Priority date | Nov 19, 2012 |
| Publication date | Sep 19, 2017 |
| Grant date | Sep 19, 2017 |
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Abstract
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The present invention relates to polymorphic forms of 5-Azacytidine and the process for preparation thereof. The present invention further relates to Crystalline 5-azacytidine 5 designated as Form-SA-1 characterized by an X-ray powder diffraction pattern having at least four characteristic diffraction angle peaks at about 12.00, 12.60, 13.90, 15.15 and 31.40±0.20 2θ°, which is useful as active pharmaceutical ingredient in pharmaceutical compositions for the treatment of myelodysplastic syndrome.
First claim
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The invention claimed is: 1. Crystalline 5-azacytidine designated as Form-SA-1 characterized by an X-ray powder diffraction pattern having at least four characteristic diffraction angle peaks at about 12.00, 12.60, 13.90, 15.15 and 31.40±0.20 2θ°. 2. Crystalline 5-azacytidine Form-SA-1 according to claim 1 ; wherein the water content is less than 1%. 3. A process for preparing Crystalline 5-azacytidine Form SA-1, characterized by an X-ray powder diffraction pattern having at least four characteristic diffraction angle peaks at about 12.00, 12.60, 13.90, 15.15 and 31.40±0.20 2θ°; comprising the steps of— (i) Dissolving 5-azacytidine in a solvent vehicle consisting of acetonitrile and refrigerated water in the ratio of 20:80 to 60:40; (ii) Freeze-drying the solution, (iii) Isolating the Crystalline 5-Azacytidine Form SA-1. 4. A process for preparing Crystalline 5-azacytidine Form SA-1 according to claim 3 , wherein refrigerated water is a precooled water having temperature of less than 5° C. and dissolving of 5-azacytidine is carried out under nitrogen purging. 5. A process for preparing Crystalline 5-azacytidine Form SA-1 according to claim 3 , wherein before freeze drying step, the step i) solution is stirred to get a clear solution.
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- What does patent US9765108B2 cover?
- The present invention relates to polymorphic forms of 5-Azacytidine and the process for preparation thereof. The present invention further relates to Crystalline 5-azacytidine 5 designated as Form-SA-1 characterized by an X-ray powder diffraction pattern having at least four characteristic diffraction angle peaks at about 12.00, 12.60, 13.90, 15.15 and 31.40±0.20 2θ°, which is useful as active …
- Who is the assignee on this patent?
- Shilpa Medicare Ltd
- What technology area does this patent fall under?
- Primary CPC classification C07H19/12. Mapped technology areas include Chemistry & Metallurgy.
- When was this patent published?
- Publication date Tue Sep 19 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 1 related publication on this page (citations in our corpus or others sharing the same primary CPC).