Process for preparation of compositions of oligomers of lactic acid

A process for preparing a composition comprising oligomers of lactic acid as an active substance, the process comprising steps of:

• i) premixing pharmaceutically acceptable excipients comprising one or more selected from the group consisting of a binder and a filler to obtain a premix;
• ii) a first wet granulation step comprising adding a first aqueous solution comprising oligomers of lactic acid to the premix to obtain a wet first granulate;
• iii) milling the wet first granulate to obtain a milled wet first granulate;
• iv) drying the milled wet first granulate and dry milling to obtain a dried first granulate;
• v) a second wet granulation step comprising adding a second aqueous solution comprising oligomers of lactic acid to the dried first granulate to obtain a wet second granulate;
• vi) milling the wet second granulate to obtain a milled wet second granulate;
• vii) drying the milled wet second granulate to obtain a dried second granulate;
• and
• viii) milling the dried second granulate to obtain a particulate material comprising the oligomers of lactic acid.