The production of pellets composed of an ephedrine derivative

A - Human Necessities – 61 – K

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A61K 31/135 (2006.01) A61K 9/16 (2006.01) A61K 9/56 (2006.01) B01J 2/00 (2006.01)

Patent

CA 2105002

A process for producing pellets which are markedly spherical and have a particle size in the range from 0.1 to 4 mm and an apparent density above 0.5 g/cm3, and which are composed of 90-100% by weight of an ephedrine derivative and 0-10% by weight of a pharmaceutical aid, entails suspending ephedrine derivative powder with an average particle size of from 0.5 to 50 µm at 0-90°C with stirring in a water- immiscible non solvent with a boiling point in the range from 60 to 160°C, adding 5-60% by weight, based on the ephedrine derivative, of an agglomerating liquid while continuing stirring, and, if there has been previous heating, cooling to from -5 to 25°C at 5-40 K per. hour, with the stirring speed being adjusted after the agglome- ration of the powder particles to a value which is necessary for the required average particle size, and removing and drying the resulting pellets. A drug which contains the active ingredient in the form of such pellets, with or without slowing of release, is also described.

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