GRF-containing lyophilized pharmaceutical compositions
Human growth hormone factor (GFR) containing pharmaceutical compositions are described, and more precisely, lyophilized compositions of hGRF stabilized by means of saccharose.
1 . A pharmaceutical composition comprising a solid intimate mixture of human growth releasing factor (hGRF) and a stabilizing amount of saccharose, alone or in combination with other excipients.
2 . The pharmaceutical composition according to claim 1 , wherein the solid intimate mixture is a lyophilizate.
3 . The pharmaceutical composition according to claim 1 , wherein the stabilizing agent is a saccharose alone.
4 . The pharmaceutical composition according to claim 1 , containing 3 or 10 mg/vial of hGRF.
5 . The pharmaceutical composition according to claim 1 comprising 3 or 10 mg/vial of hGRF and 20.52 or 68.4 mg/vial of saccharose.
6 . The pharmaceutical composition according to claim 1 further comprising buffering agents.
7 . A process for preparing a pharmaceutical composition according to claim 1 , comprising the preparation of an aqueous solution of the components, the distribution within containers and the lyophilization in the containers.
8 . Forms of presentation of said pharmaceutical composition comprising the solid mixture according to claim 1 , hermetically closed in a sterile condition within a container suited for a storage before use and for reconstitution of the mixture into a solvent or into a solution for injectables.
9 . A solution comprising the solid mixture according to claim 1 , reconstituted in a solvent or a solution for injectables.
10 . The pharmaceutical composition according to claim 2 , wherein the stabilizing agent is a saccharose alone.
11 . The pharmaceutical composition according to claim 2 , containing 3 or 10 mg/vial of hGRF.
12 . The pharmaceutical composition according to claim 1 comprising 3 or 10 mg/vial of hGRF and 20.52 to 68.4 mg/vial of saccharose.
13 . The pharmaceutical composition according to claim 2 further comprising buffering agents.
14 . The pharmaceutical composition according to claim 13 buffered to a pH between 2 and 7.
15 . The pharmaceutical composition according to claim 14 buffered to a pH of 4 to 6.
16 . A pharmaceutical composition consisting of a lypholized solid intimate mixture of human growth releasing factor (hGRF) and a stabilizing amount of saccharose as the sole stabilizing agent, a buffer which maintains the pH between 2 and 7, and optionally, excipients.
17 . The pharmaceutical composition according to claim 16 in which the buffer maintains the pH between 4 and 6.
18 . A unit dose of the pharmaceutical composition according to claim 17 in which the amount of hGRF is 3 to 10 mg and the amount of saccharose is from 20.52 to 68.4 mg.