Polymorphic Form b of telmisartan, mixtures of polymorphs of telmisartan, a process for the preparation of telmisartan containing polymorphic form B, and the use of telmisartan to prepare a Medicine

摘要

Forma B polimorfa del cido 4 - 2-n-propil-4-metil-6- (1-metilbencimidazol-2-il) bencimidazol-1-ilmetil -bifenil-2-carbox lico (INN Telmisart n)of formula (1) that is characterized by an endothermic maximum of 183 +/- 2 ° C that manifests itself in thermal analysis using CBD (differential scanning calorimetry). The mixtures of the polymorphic forms A - which was already known in the state of the art - and the polymorphic form B that make up Telmisartan, and the use of the latter to prepare a medicine. A procedure for preparing Telmisartan, which contains the polymorphic form B, in which only form B with its characteristic macroscopic crystalline form is first obtained,When conditions permit, the system remains basically unchanged due to the polymorphism at the end of drying due to the partial change of type B. The procedure includes: (a) mixing the electric mass into a solvent composed of water, folic acid and degradable organic solvent, heating and then filtering the obtained solution; (b) The organic solvent is separated by distillation - finally, it is mixed by a separator using water at the same time;(c) A substrate was added to accelerate the formation of B-type residual solution in electronics; (d) centrifugation, washing and drying.