Controlled release peptide formulations

A process for the formation of a pre-formulation suitable for the administration of a peptide bioactive agent to a subject, said process comprising forming a low viscosity mixture consisting of:

• a) a lipid component consisting of:
• at least 95 wt % of:
• a1) 20-80 wt % of at least one diacyl glycerol and/or a tocopherol;
• and
• a2) 20-80 wt % of at least one phosphatidyl choline (PC);
• and
• 0-5 wt % of at least one impurity associated with components a1) and/or a2);
• b) 5-15 wt % of ethanol;
• c) 5-15 wt % of propylene glycol;
• d) about 2-5 wt % of octreotide or a halide thereof or a physiologically acceptable acid thereof;
• and
• e) optionally 0.0008-0.1 wt % at least one antioxidant selected from the group consisting of ascorbic acid, EDTA, and citric acid;
• wherein the ratio of components a1:a2 is in the range 45:55 to 54:46;
• wherein components b) and c) are present in the pre-formulation in an approximately equal amount;
• wherein component d) is dissolved or dispersed in the low viscosity mixture, or in at least one of components a1), a2), b), c) and optionally e) prior to forming the low viscosity mixture;
• wherein the pre-formulation formed has a viscosity of 10-750 mPas at 20° C.