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|Title:||Pharmaceutical composition containing diphosphonic acid or salt thereof|
|Abstract:||The invention relates to a solid pharmaceutical form of administration containing a diphosphonic acid or a physiologically compatible salt thereof as the active substance, wherein the active substance is present in granulate form, optionally together with pharmaceutical adjuvants in the inner phase, and the outer phase contains a lubricant in the form of less than 5% by weight of stearic acid relative to the total weight of the form of administration.|
|Inventor(s):||Gabel; Rolf-Dieter (Schwetzingen, DE), Preis; Walter (Neustadt, DE), Woog; Heinrich (Laudenbach, DE)|
|Assignee:||Hoffmann-La Roche Inc. (Nutley, NJ)|
|Filing Date:||Jul 20, 2001|
|Claims:||1. A process for producing a pharmaceutical composition in solid unit dosage form comprising granulating a binder and a ibandronic acid, a physiologically compatible salt thereof or hydrate and one or more pharmaceutically acceptable additives with water to form a granulate, the ibandronic acid being present in the dosage form in an amount of from about 0.2% to 30% by weight of the dosage form, wherein an inner phase comprises about 80% by weight of the dosage form and an outer phase comprises from about 0.1% to about 20% by weight of the dosage form; mixing the granulate with less that about 5% stearic acid to form a mixture having the inner phase and the outer phase wherein the inner phase of the mixture contains stearic acid in an amount of about less that 5% by weight of said mixture; and forming a solid unit dosage form from said mixture. |
2. A process according to claim 1, wherein at least one adjuvant is added to the stearic acid prior to mixing the stearic acid with the granulate.
3. A process according to claim 1, wherein the outer phase of the mixture includes at least one adjuvant wherein the adjuvant is added individually to the granulate.
4. A process according to claim 1, wherein at least one adjuvant is granulated with the binder and diphosphonic acid or physiologically compatible salt, said adjuvant being selected from the group consisting of lactose, starch, glucose, mannitol, microcrystalline cellulose, hydroxypropyl methyl cellulose and polyvinyl pyrrolidone.