Pharmaceutical composition comprising amorphous lenalidomide and an antioxidant
AssigneeSynthon BV
InventorsMarta VIVANCOS MARTINEZ, Lisardo ALVAREZ FERNANDEZ, Jose VELADA CALZADA
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Abstract
The present invention relates to a pharmaceutical composition comprising amorphous lenalidomide, or a pharmaceutically acceptable salt thereof, with a synthetic antioxidant and one or more pharmaceutically acceptable excipients. The invention further relates to the process to manufacture such a compositions and the use of said composition as a medicament, particularly in the treatment of in the treatment of multiple myeloma and myelodyplastic syndromes.
Claims20
-12. (canceled)
A lenalidomide pharmaceutical granule, comprising a diluent carrying a polymer composition, wherein said polymer composition comprises a polymer containing a solid dispersion of amorphous lenalidomide, or a pharmaceutically acceptable salt thereof, and a monophenolic antioxidant compound.
A process which comprises the steps of:
- a) Dissolving lenalidomide or a pharmaceutically acceptable salt thereof with a polymer and a monophenolic antioxidant compound in a solvent to form a solution;
- b) Spraying the solution of step a) on a carrier to obtain a granule;
- c) Blending the granule with at least one excipient;
- and
- d) Optionally encapsulating the blend of step c.
Dependencies are inferred from the claim text.