A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 31/485 (2006.01) A61K 9/16 (2006.01) A61K 9/20 (2006.01) A61K 9/26 (2006.01) A61K 9/28 (2006.01) A61K 9/50 (2006.01) A61K 9/52 (2006.01) A61K 31/135 (2006.01) A61K 31/137 (2006.01) A61K 31/522 (2006.01)
Patent
CA 2127166
In order to provide a sustained release pharmaceutical formulation containing morphine which is suitable for administration on a once daily basis, in a first aspect, an orally administrable sustained release dosage unit form contains morphine, or a pharmaceutically acceptable salt thereof, as active ingredient, which formulation gives a peak plasma level at 1.0 to 6 hours after administration. In a second aspect, the formulation contains an effective amount of morphine or a pharmaceutically acceptable salt thereof, characterised by a W50 for the M-6-G metabolite or for morphine of between 4 and 12 hours. In a third aspect, the pharmaceutical dosage unit form is obtainable by compressing multiparticulates comprising a pharmaceutically active substance in a matrix of hydrophobic fusible material having a melting point of from 35 to 150°C, the dosage form optionally containing conventional tabletting excipients. In a further aspect of the invention, sustained release multiparticulates containing morphine or a pharmaceutically acceptable salt thereof are produced by mechanically working in a high-speed mixer a mixture of particulate morphine or a pharmaceutically acceptable salt thereof and a particulate, hydrophobic fusible carrier or diluent having a melting point from 35 to 150°C and optionally a release control component comprising a water soluble fusible material or a particulate soluble or insoluble organic or inorganic material at a speed and energy input which allows the carrier or diluent to melt or soften whereby it agglomerates, and breaking down the agglomerates to give controlled release particles.
Brown Miller Ronald
Chasin Mark
Goldenheim Paul
Heafield Joanne
Kaiko Robert F.
Borden Ladner Gervais Llp
Brown Miller Ronald
Chasin Mark
Euro-Celtique S.a.
Goldenheim Paul
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