New galenic formulations of meloxicam for oral administration

摘要

A salt of meloxicam (4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-ca rboxamide 1,1-dioxide) with an inorganic or organic base (especially the sodium, potassium, ammonium, meglumine, tris or basic amino acid salt) is used to prepare an orally administrable solid dosage form from which the active ingredient is rapidly released and absorbed in the treatment of pain. Independent claims are also provided for the following: (1) an orally administrable solid meloxicam dosage form comprising a salt of meloxicam with an organic or inorganic base as above, optionally together with excipients and/or carriers, in a rapidly disintegrating tablet produced by direct tabletting; (2) production of an orally administrable solid meloxicam dosage form having a short disintegration time and providing rapid release and absorption of meloxicam by mixing an optionally pulverized salt of meloxicam with an organic or inorganic base as above with pulverized excipients and/or carriers and directly compressing the ungranulated powder into tablets; (3) crystalline meloxicam meglumine salt monohydrate (I) and crystalline meloxicam meglumine salt dihydrate (II); (4) production of (I) by heating meloxicam and meglumine in a mixture of water and a water-miscible organic solvent (especially acetone, methanol, ethanol, n-propanol, i-propanol, tetrahydrofuran or dioxan) and adding seed crystals of (I); (5) production of (II) by keeping crystalline (I) at an air humidity of at least 75 %; (6) a process as in (2) using (I) prepared as in (4); (7) a process as in (2) using (II) prepared as in (5).