Method for preparing a solid dosage form comprising antibodies by wet granulation, extrusion and spheronization

A method for preparing a solid dosage form comprising at least one antibody or functional fragment thereof, a surfactant, an extrusion-spheronization aid, a buffer, a disintegrant and at least one further excipient selected from the group consisting of fillers, sustained release agents and combinations thereof, said method comprising the steps of:

• a) providing a powder blend comprising the extrusion-spheronization aid, the disintegrant, and the at least one further excipient;
• b) adding a binding liquid to the powder blend of step a) and granulating to obtain a wet mass;
• c) extruding the wet mass of step b) and collecting an extrudate;
• d) spheronizing the extrudate of step c) to obtain wet spheroids;
• and
• e) drying the wet spheroids to obtain the solid dosage form;
• wherein the at least one antibody or functional fragment thereof, the buffer, and the surfactant are contained within the powder blend and/or the binding liquid.