Appeal No. 2003-0913 2
Application No. 09/277,049
meloxicam and a conventional powdered carrier or excipient. In a specific embodiment
the meloxicam salt is a meloxicam meglumin salt monohydrate or dihydrate. A separate
embodiment is also directed to a method for the preparation of the meloxicam meglumin
monohydrate and dihydrate salts. Additional limitations are described in the following
illustrative claims.
THE CLAIMS
Claims 1, 6 and 14 are illustrative of appellants’ invention and are reproduced below.
1. A solid pharmaceutical composition suitable for oral administration comprising:
(a) a salt of meloxicam selected from the group consisting of the
sodium salt, the potassium salt, the ammonium salt, the salt formed
with meglumin, the salt formed with Tris-
(hydroxymethyl)aminomethane, and the salts formed with basic
amino acids; and
(b) a conventional powdered carrier or excipient.
6. Crystalline meloxicam meglumin salt monohydrate or crystalline meloxicam
meglumin salt dihydrate.
14. A process for preparing an orally administrable solid pharmaceutical preparation
containing meloxicam in the form of the crystalline meloxicam-meglumin salt
monohydrate, the process comprising:
(a) heating meloxicam and meglumin in a solvent mixture of a water-
miscible organic solvent and water;
(b) adding meloxicam-meglumin salt monohydrate seed crystals to the
solvent mixture containing meloxicam and meglumin to obtain
crystalline meloxicam-meglumin salt monohydrate;
(c) separating crystalline meloxicam-meglumin salt monohydrate from
the solvent mixture;
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