| 简介 |
Solid pharmaceutical composition for oral administration of acid or a salt or a [...] pharmaceutically acceptable hydrate thereof, method for preparing said composition by direct compression, pharmaceutical formulations containing said composition and process for preparing the said formulations. The present invention relates to a solid pharmaceutical composition in the form of a unit dosage, for oral administration of ibandronic acid, obtained by a process of direct compression, comprising 30 37% by weight of ibandronic acid or a pharmaceutically acceptable salt or hydrate thereof, at least one diluent, in amount of approximately 55 65% by weight, at least one scattering agent in the amount of approximately 0.5 1.5% by weight and at least one lubricant in amount of approximately 4.5 5.5% by weight. The invention also comprises a process of direct compression to prepare the compositions, as well as, pharmaceutical formulations comprising covering said compositions and a process for preparing said pharmaceutical formulations covered. |
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