THE EFFERVESCENT PHARMACEUTICAL DOSAGE FORM OF ESTERS AND ESTER SALTS OF 6 alpha METHYLPREDNISOLONE SUCCINATE, PROCEDURE FOR ITS OBTAINING AND APPLICATION

摘要

The invention relates to a pharmaceutical product in the form of an effervescent water soluble tablet, which contains as an active substance 6 alpha Methylprednisolone derivatives in the form of Methylprednisolone Hydrogen Succinate ester or Methylprednisolone Sodium Succinate ester type salt. The invention is related to qualitative and quantitative composition as well as to the procedure of obtaining a new galenic form. The effervescent product is made of granulate, composed of stabilised effervescent cores, whereby such cores are stabilised with a layer of citrate - buffer substance. The cores contain inorganic salts of potassium and/or sodium carbonate and organic acid - lemon acid and docusate sodium as surfactant, whereby the active component is incorporated in the effervescent core with the use of the surfactant. In the course of the incorporation process, stabilisation is performed and complete solubility of the active principle is provided.