Pharmaceutical composition comprising amorphous lenalidomide
AssigneeSynthon BV
InventorsRolf Keltjens, Jacobus Theodorus Henricus Van Eupen, Deepak Murpani, Marta Vivancos Martinez, Lisardo Alvarez Fernandez, Luis Nogueiras Nieto
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Abstract
The present invention relates to a pharmaceutical composition comprising an inclusion complex of amorphous lenalidomide, or a pharmaceutically acceptable salt thereof, in non-substituted β-cyclodextrin and one or more pharmaceutically acceptable excipients. The invention further relates to the use of said composition as a medicament, particularly in the treatment of in the treatment of multiple myeloma and myelodysplastic syndromes.
Claims12
A pharmaceutical composition comprising (i) an inclusion complex of amorphous lenalidomide, or a pharmaceutically acceptable salt thereof, with a non-substituted β-cyclodextrin in a weight ratio of lenalidomide to non-substituted β-cyclodextrin ranging from 1:1 to 1:4 and (ii) one or more pharmaceutically acceptable excipients, wherein said composition exhibits a dissolution rate of at least 85% in 15 minutes when tested in at least one of 900 ml SGF pH 1.2 or pH 2, acetate buffer pH 4.5, or phosphate buffer pH 6.8 in a USP apparatus II at 75 rpm in standard vessels or at 50 rpm with peak vessels.
Dependencies are inferred from the claim text.