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Claims for Patent: 6,610,327

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Claims for Patent: 6,610,327

Title: Pharmaceutical moxifloxacin preparation
Abstract:The present invention relates to a pharmaceutical preparation for oral administration which comprises moxifloxacin, its salt and/or hydrate and lactose, to a process for its preparation, and to the use of this preparation for controlling bacterial infections in humans and animals.
Inventor(s): Bosche; Patrick (Odenthal, DE), Mahler; Hans Friedrich (Koln, DE), Weisemann; Claus (Apex, NC)
Assignee: Bayer Aktiengesellschaft (Leverkusen, DE)
Application Number:09/830,770
Patent Claims: 1. Pharmaceutical preparation for oral administration which comprises moxifloxacin or a salt and/or hydrate thereof, at least one dry binder, at least one disintegrant, and at least one lubricant, characterized in that the preparation comprises from 2.5% to 25% of lactose.

2. Pharmaceutical preparation for oral administration according to claim 1, characterized in that the preparation comprises from 50 to 800 mg of moxifloxacin or its salts and/or hydrates, based on an individual dosage.

3. Pharmaceutical preparation for oral administration according to claim 1 or 2, characterized in that the dry binder is microcrystalline cellulose.

4. Pharmaceutical preparation for oral administration according to claim 1, characterized in that the disintegrant is croscarmellose sodium.

5. Pharmaceutical preparation for oral administration according to claim 1, characterized in that the lubricant is magnesium stearate.

6. Pharmaceutical preparation for oral administration according to claim 1, characterized in that it comprises: from 60 to 76% of moxifloxacin or a salt and/or hydrate thereof, from 7.5 to 16% of lactose, from 2 to 6% of croscarmellose sodium from 0.5 to 1.1% of magnesium stearate, and up to 30% of microcrystalline cellulose.

7. Tablet preparation for oral administration which comprises a core of the pharmaceutical preparation according to claim 1 and a film coating.

8. Pharmaceutical preparation for oral administration according to claim 1, characterized in that it comprises moxifloxacin hydrochloride.

9. Process for preparing the pharmaceutical preparation for oral administration according to claim 1, characterized in that moxifloxacin, its salt and/or hydrate, at least one dry binder and lactose are granulated using water, the granules are subsequently mixed with at least one disintegrant and at least one lubricant.

10. A method of treating a bacterial infection in a human or animal, comprising administering to a patient in need thereof an effective amount of an oral pharmaceutical preparation according to claim 1.
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