Acetic acid-solvate of risedronate, useful e.g. to treat or prevent bone resorption disorder, tumors or a disturbed calcium- or phosphate-metabolism

摘要

Acetic acid-solvate of risedronate, is claimed. Independent claims are included for: (1) a polymorph Ac 1 of the monosodium risedronate-diacetic acid-solvate designated by the characteristic diffraction lines (2theta in angle degree of +- 0.2[deg] ) in the X-ray powder diffractogram at 8.1, 9.1, 10.1, 12.1, 14.3, 15, 17, 18, 18.9, 19.6, 20.7, 21.3, 23.2, 23.6, 24.7, 25.5, 27.8 and 31.6, preferably by the use of copper potassium alpha-1 radiation and absorption in transmission; (2) a pharmaceutical composition comprising the acetic acid-solvate or polymorph Ac 1 as active substance, optionally together with one or more carriers and/or one or more auxiliary materials; and (3) preparing acetic acid-solvate, comprising: either dissolving the risedronate in acetic acid or an acetic acid/solvent-mixture under heating and precipitating the risedronate-acetic acid-solvate by cooling the obtained solution or by adding the same or other solvents; or suspending the risedronate in acetic acid or an acetic acid/solvent-mixture. ACTIVITY : Osteopathic; Cytostatic; Metabolic. MECHANISM OF ACTION : None given.