Organic compounds

Abstract

A pharmaceutical composition for parenteral administration of a somatostatin analogue salt of aspartate, e.g. mono- or diaspartate, lactate, succinate, e.g. mono- or disuccinate, acetate, glutamate, e.g. mono- or diglutamate or citrate and water forming a gelling depot system after injection in contact with the body fluid.

1 . A pharmaceutical composition for parenteral administration comprising a somatostatin analogue salt of mono- or diaspartate, mono- or diglutamate, mono- or disuccinate, acetate or citrate and water forming a gelling depot system after injection in contact with body fluid. 
   
   
       2 . A pharmaceutical composition for parenteral administration comprising a somatostatin analogue salt of mono- or diaspartate, mono- or diglutamtate, lactate, mono- or disuccinate, acetate or citrate and water, having a pH of between 3.0 and 7.0, forming a gelling depot system after injection in contact with body fluid. 
   
   
       3 . The pharmaceutical composition of  claim 1  wherein the somatostatin analogue salt has a salt: base ratio ranging from 0.1 to 2. 
   
   
       4 . The pharmaceutical composition according to  claim 2  having a pH of between about 4.0 and 6.0. 
   
   
       5 . The pharmaceutical composition according to  claim 4  having a pH of between about 4.0 and 5.0. 
   
   
       6 . The pharmaceutical composition according to  claim 1  comprising a pharmaceutically acceptable buffer in an amount to provide a pH of between about 3 and 7. 
   
   
       7 . The pharmaceutical composition according to  claim 6  having a pH of between about 4.0 and 5.0. 
   
   
       8 . The pharmaceutical composition according to  claim 6  wherein the pharmaceutically acceptable buffer is chosen from at least one of an acetate buffer, a tartrate buffer, a glycin buffer and a lactate buffer. 
   
   
       9 . The pharmaceutical composition according to  claim 6  wherein the pharmaceutically acceptable buffer is acetate buffer. 
   
   
       10 . The pharmaceutical composition according to  claim 9  wherein the acetate buffer is used in a concentration of about 10 mM to 25 mM. 
   
   
       11 . The pharmaceutical composition according to  claim 1  wherein said gelling depot system releases somatostatin analogue salt of aspartate, lactate, succinate, acetate, glutamate or citrate continuously within the patient over an extended period of time of from 1 to 90 days. 
   
   
       12 . The pharmaceutical composition of  claim 11  wherein said gelling depot system releases somatostatin analogue salt of aspartate, lactate, succinate, acetate, glutamate or citrate continuously within the patient over an extended period of time of from 1 to 60 days. 
   
   
       13 . The pharmaceutical composition according to  claim 1  having a viscosity from 1 to 106 mPa s. 
   
   
       14 . A prefilled syringe comprising the composition of  claim 1  and instructions to use. 
   
   
       15 . A process to prepare the pharmaceutical composition according  claim 1  comprising
 dissolving a somatostatin analogue salt of mono- or diaspartate, mono- or diglutamate, lactate, mono- or disuccinate, acetate or citrate in water,   optionally adding a pharmaceutically acceptable amount of a buffer, and optionally filling the solution into a syringe.   
   
   
       16 . A process to prepare the pharmaceutical composition according to  claim 1  comprising
 dissolving a somatostatin analogue salt of mono- or diaspartate, mono- or diglutamate, lactate, mono- or disuccinate, acetate or citrate in water,   adding a pharmaceutically acceptable amount of a buffer to obtain a pH of between 3.0 and 7.0, and optionally   filling the solution into a syringe.