Parenteralt administrerbara mikropartiklar och förfarande för framställning av desamma

摘要

Microparticles comprise biodegradable starch as a matrix containing biologically active substance in non-chemically complex-bonded form and in the form of solid particles having a mean size of 0.05 - 30 micro m. An Independent claim is included for producing the microparticles involving: (a) preparing an aqueous solution of the active substance; (b) mixing the solution of (a) with an aqueous solution of polyethylene glycol (PEG) to obtain a concentrated and/or solidified substance (a1); (c) optionally washing (a1) to obtain solution (a2); (d) mixing (a1) or (a2) with an aqueous starch solution to obtain a composition (a3) (e) mixing (a3) with an aqueous solution of a polymer (preferably PEG) having the ability of forming a two-phase aqueous system to form an emulsion of starch droplets containing active substance as the inner phase in an outer phase of the polymer solution; (f) solidifying the starch droplets of step e) to starch microparticles (a4); (g) drying (a4); and (h) optionally applying a release controlling shell of a biocompatible and biodegradable polymer to the dried starch microparticles.