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Summary for Patent: 6,294,196
|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)|
1. A pharmaceutical composition in solid unit dosage form, said dosage form comprising an inner phase containing as the active substance ibandronic acid, or a physiologically
compatible salt or hydrate thereof, said active substance being present in the dosage form in an amount of from about 0.2% to 30% by weight of the dosage form, and an outer phase containing stearic acid in an amount of about less than 5% by weight of the
dosage form, wherein said inner phase comprises about at least 80% by weight of the dosage form and said outer phase comprises from about. 0.1% to 20% by weight of the dosage form.
2. The composition according to claim 1, wherein the outer phase of the dosage form contains stearic acid in an amount of from about 0.1 to about 3% by weight of said dosage form.
3. The composition according to claim 1, wherein the outer phase of the dosage form contains stearic acid in an amount of from about 0.98 to about 3% by weight of said dosage form.
4. The composition according to claim 1, wherein the outer phase of the dosage form contains stearic acid in an amount of from about 1.5 to about 2.7% by weight of said dosage form.
5. The composition according to claim 1, wherein the active substance is present in said dosage form in an amount of from about 0.5 to about 50 mg.
6. The composition according to claim 1, wherein the outer phase of said dosage form contains a disintegrating agent.
7. The composition according to claim 6, wherein the disintegrating agent is cross-linked polyvinyl pyrrolidone.
8. The composition according to claim 1, wherein said solid unit dosage form is selected from the group consisting of tablets, capsules, film tablets, dragees, pellets, effervescent tablets, chewing tablets and granulates in sachets.
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