Process for preparing etofibrate or similar compounds containing sustained release microgranules and products thus obtained.

摘要

The present invention relates to the pharmaceutical field and particularly to the manufacturing of a pharmaceutical product named etofibrate in the form of sustained release microgranules, wherein each microgranule consists entirely of an etofibrate composition and polyethylene glycol 4000, said microgranules being placed in capsules that, size of known capsules being equal, display an higher concentration of the active ingredient, the process for preparing the above microgranules comprising mainly the manufacturing of a compound consisting of etofibrate and solvent, wherein said compound is obtained in rotatory pan, then submitting this compound to a first sieving, placing it again in rotatory pan, drying the product thus obtained and sieving it once more, separating the microgranules which are replaced in the rotatory pan and then coated in rotatory pan with further etofibrate added with a suitable amount of polyethylene glycol 4000 to give, after a last sieving, the desired microgranules whose size corresponds to the requested size and is normally comprised between 400 and 2000 microns.