A NEW VAMOROLONE FORMULATION SHOWS IMPROVED SOLUBILITY
Patent Information
- Authority / Receiving Office
- RU · RU
- Patent Type
- Applications
- Current Assignee / Owner
- SANTHERA PHARMACEUTICALS (SCHWEIZ) GMBH
- Filing Date
- 2024-02-07
- Publication Date
- 2026-07-03
Claims
1. An amorphous solid dispersion comprising vamorolone and at least one pharmaceutically acceptable polymer.
2. An amorphous solid dispersion according to claim 1, characterized in that vamorolone is present in an amount of at least 20% by weight of the mass of the amorphous solid dispersion.
3. An amorphous solid dispersion according to any one of claims 1, 2, containing vamorolone in an amount of 40 to 60% by weight of the amorphous solid dispersion and a total amount of polymer of 40 to 60% by weight of the amorphous solid dispersion.
4. An amorphous solid dispersion according to any one of claims 1 to 3, containing a polymer selected from cellulose, cellulose derivatives, povidone, copovidone, methacrylic acid derivatives and / or methyl methacrylate.
5. An amorphous solid dispersion according to any one of claims 1 to 4, containing a polymer selected from HPMC, HPC, HPMCAS-L, HPMCAS-M, povidone and copovidone.
6. An amorphous solid dispersion according to any one of claims 1-5, containing other ingredients in an amount of no more than 3% by weight of the amorphous solid dispersion.
7. An amorphous solid dispersion according to any one of paragraphs 1-6, characterized in that the amorphous solid dispersion of vamorolone is obtained by spray drying.
8. A pharmaceutical composition comprising an amorphous solid dispersion according to any one of claims 1-7 and a pharmaceutically acceptable excipient.
9. The pharmaceutical composition according to claim 8, containing vamorolone in an amount of at least 20% by weight of the pharmaceutical composition.
10. The pharmaceutical composition according to claim 8 or 9, further comprising a filler, a binder, a disintegrating agent, a lubricant, a glidant and / or a film coating.
11. A pharmaceutical composition according to any one of claims 8-10, which is a tablet or capsule.
12. Use of a polymer to improve the solubility of vamorolone in an aqueous medium by dispersing the amorphous form of vamorolone in the polymer.
13. A method for producing an amorphous solid dispersion according to any one of claims 1-7 by spray drying.