New intermediate comprising lenalidomide and matrix material, in the form of a solid solution, useful e.g. as immunomodulatory drug, to inhibit proliferation of hematopoietic tumor cells and promote T-cell and natural killer cell immunity

摘要

Intermediate comprising lenalidomide and a matrix material, in the form of a solid solution, is new. Independent claims are also included for: (1) the preparations of the intermediate; (2) a pharmaceutical composition comprising lenalidomide in the form of the intermediate and optionally at least one further pharmaceutical excipient; and (3) identifying a pharmaceutical excipient, which is suitable as the matrix material for lenalidomide in the form of a solid solution, comprising (i) providing lenalidomide and a pharmaceutical excipient, which is present in solid aggregate form at 25[deg] C, in a ratio of 1:1, (ii) heating twice the solid excipient and identifying the glass transition temperature of the excipient by differential scanning calorimetry, (iii) heating twice lenalidomide and identifying the glass transition temperature of the active substance by differential scanning calorimetry, (iv) heating twice the 1: 1 mixture of lenalidomide and the excipient and identifying the glass transition temperature of the mixture by differential scanning calorimetry, and (iv) selecting the suitable excipient by ensuring that the glass transition temperature of the mixture lies between the glass transition temperature of the excipient and the active substance. ACTIVITY : Immunomodulator; Cytostatic. No biological data given. MECHANISM OF ACTION : None given.