Process for the preparation of pharmaceutical compositions for the sustained release of somatostatin analogs

A process for preparing an injectable sustained release pharmaceutical composition, the process comprising the steps of:

• lyophilizing a mixture comprising a somatostatin analog salt and an aqueous acid solution in a stepwise temperature pattern, wherein the temperature is:
• initially reduced from room temperature to 1 to 3° C.;
• then reduced from to −45 to −35° C.;
• then increased to 20 to 30° C. and
• then increased to 30 to 40° C.;
• and
• hydrating the resulting lyophilizate;
• wherein:
• the lyophilization is performed only once;
• and
• the final pH of the composition is from 5 to 7.