THE EFFERVESCENT PHARMACEUTICAL DOSAGE FORM OF ESTERS AND ESTER SALTS OF 6 alpha METHYLPREDNISOLONE SUCCINATE, PROCEDURE FOR ITS OBTAINING AND APPLICATION
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 i...
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| Format: | Patent |
| Sprache: | eng ; fre |
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| Zusammenfassung: | 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.
L'invention concerne un produit pharmaceutique sous la forme de pastille effervescente hydrosoluble contenant en tant que substance active des dérivés de 6 alpha- méthylprednisolone sous la forme d'hydrogénosuccinate de méthylprednisolone et de succinate de méthylprednisolone sel de sodium. L'invention concerne une composition qualitative et quantitative ainsi qu'un procédé d'obtention de cette forme galénique. Le produit effervescent est constitué de particules de coeur effervescentes stabilisées, en granules, enrobées d'une substance de tampon au citrate. Les particules de coeur contiennent des sels inorganiques de carbonate de sodium et/ou de potassium et un acide organique-acide citrique et du docusate de sodium en tant que tensioactif, le composant actif étant incorporé dans le coeur effervescent au moyen du tensioactif. Lors du processus d'incorporation, la stabilisation est réalisée et la solubilité complète du principe actif est obtenue. |
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