Patent ID: 6194005
Filing Date: 2001-02-27
Classification: A61K

Abstract:
Process for the manufacture of a pharmaceutical composition with modified release of active principle whereina powder comprised of an active principle and, optionally, an adjuvant, is mixed, while heating and fluidizing, in order to obtain individual grains;a lipid matrix agent comprised of partial esters of alcohol with at least one fatty acid is liquefied separately under warm conditions;the powder is then coated under warm conditions by spraying from 1 to 15% by weight of the final composition of the liquefied lipid matrix agent over the individual grains, wherein the spraying air pressure, and optionally the spraying rate, are varied throughout the coating operation so as to promote either the formation of a homogeneous film around the individual grains or the agglomeration of the individual grains with one another;finally, the temperature of the combined product is lowered in order to allow the lipid matrix agent to solidify around the grains.