PROCESS FOR PRODUCING OMPERAZOLE AND MAGNESIUM CARBONATE HYDROXYD DOUBLE SALT IN NOTSTOICHIOMETRIC PORTIO AND PHARMACEUTICAL COMPOSITIONS CONTAINING IT

• Main Authors: DAVID AGOSTON, BENKOCZI ZOLTAN, GAL LIVIA, OESZI ZSOLT, BARDOS ATTILA, ACS ZOLTAN, GRESKOVITS DAVID
• Format: Patent
• Language: English
• Published: 28.09.2002
• Edition: 7

Preparation of a novel non-stoichiometric solid-phase addition compound, omeprazole-magnesium-carbonate-hydroxide (pharmacopoeia name), comprises e.g.: preparing magnesium-dihydroxy-tricarbonate by adding to one mole of omeprazole, a quantity equivalent to 0.5-2.0 Mg-ions taken from a double salt prepared according to the rules of the pharmacopoiea, and containing 22.5-25.4 Mg ions. Preparation of a novel non-stoichiometric solid-phase addition compound, omeprazole-magnesium-carbonate-hydroxide (pharmacopoeia name), comprises: preparing magnesium-dihydroxy-tricarbonate by adding to one mole of omeprazole, a quantity equivalent to 0.5-2.0 Mg-ions taken from a double salt prepared according to the rules of the pharmacopoiea, and containing 22.5-25.4 Mg ions. The preparation is conducted in the presence of an organic solvent or a mixture of solvents, preferably 0.3-0.5 pts.wt. of 96% ethanol, with kneading and agitation of the heterogeneous phase. The preparation is allowed to stand for 30 minutes prior to granulation followed by drying to constant weight at 40 [deg]C and final regranulation. This non stoichiometric omeprazole magnesium-carbonate-hydroxide is formulated with excipients to form enterosolvent film-coated acid resistant capsules, tablets or uncoated rectal preparations.