Preformulation of Low Viscosity comprising pasireotide, somatostatin receptor agonist； Process for preparing the pharmaceutical preformulation； kit； used to treat acromegaly or Cushing's disease.
The present invention relates to compositions forming a low viscosity mixture of: a) 20-50 wt. % of at least one diacyl glycerol； b) 20-54 wt. % of at least one phosphatidyl choline (PC)； c) 5-15 wt. % of at least one biocompatible, organic mono-alcoholic solvent； d) 1 to 20 wt. % polar solvent e) 5 to 150 mg/ml of at least one peptide somatostatin receptor agonist comprising pasireotide； f) optionally at least one antioxidant； wherein the ratio of components a:b is in the range 40:60 to 54:46； wherein the pre-formulation forms, or is capable of forming, at least one liquid crystalline phase structure upon contact with excess aqueous fluid. The invention further relates to methods of treatment comprising administration of such compositions, and to pre-filled administration devices and kits containing the formulations.PREFORMULACIÓN QUE COMPRENDE: 20-50% DE UN DIACILGLICEROL, 20-54% DE UNA FOSFATIDIL COLINA, 5-15% DE UN SOLVENTE MONO-ALCOHÓLICO ORGÁNICO, 1-20% DE UN SOLVENTE POLAR, 5-150 mg/ml DE PASIREOTIDA Y OPCIONALMENTE UN ANTIOXIDANTE； DISPOSITIVO； KIT； PROCESO DE PREPARACIÓN； USO PARA TRATAR ENFERMEDAD DE CUSHING O ACROMEGALIA.
