Polymeric Drug-Delivery Material, Method For Manufacturing Thereof And Method For Delivery Of A Drug-Delivery Composition

A method for manufacturing a drug delivery composition, comprising:

• providing a dry polymer powder comprising a polymer;
• kneading the dry polymer powder under consecutive addition of small amounts of an aqueous solution to form an elastic polymer body having a polymer-water weight ratio between 2:1 to 1:2;
• providing a drug powder comprising a pharmaceutically-active macromolecular drug selected from the group consisting of a bioactive protein and a nucleic acid;
• adding, at ambient temperature or at a temperature below ambient but above the water-freezing point, the drug powder to the elastic polymer body and kneading the drug powder and the elastic polymer body to form a semi-solid or elastic drug delivery composition, wherein the drug delivery composition is composed of at least 90 wt % of the polymer.

A method for manufacturing a drug delivery composition, comprising:

• providing a powder of a pharmaceutically-active macromolecular drug selected from the group consisting of a bioactive protein and a nucleic acid;
• mixing the powder at least with water to obtain an aqueous drug suspension;
• providing a dry polymer powder comprising a polymer;
• kneading, at a temperature below ambient but above the water-freezing point, the polymer powder under consecutive addition of small amounts of the aqueous drug suspension to form a semi-solid or elastic drug delivery composition having a polymer-water weight ratio between 2:1 to 1:2, wherein the drug delivery composition is composed of at least 90 wt % of the polymer.

A sustained drug-releasing dosage form, comprising:

• a drug delivery composition comprising:
• a matrix comprising a polymer;
• a pharmaceutically-active macromolecular drug selected from the group consisting of a bioactive protein and a nucleic acid, wherein the pharmaceutically-active macromolecular drug is homogeneously distributed throughout the matrix;
• the drug delivery composition being paste-like, semi-solid or elastic and composed of at least 90 wt % of the polymer;
• wherein the drug delivery composition is capable of sustained release of the pharmaceutically-active macromolecular drug over a sufficiently long period so that at least 10%, preferably at least 20% and more preferably at least 30% of the pharmaceutically-active macromolecular drug has been released after 2 weeks;
• and wherein the dosage form has a size and shape suitable for injection into a human or mammalian eye.