Granular delayed-release form of pharmaceutically active substances
AssigneeZyma SA
InventorKimon Ventouras
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Abstract
A granular delayed-release form of pharmaceutically active substances, which is prepared by coating a granulated or crystalline pharmaceutically active substance, or mixtures thereof, with a coating material mixture consisting essentially of a homogeneous mixture of a poly(H+meth)-acrylic acid-(methyl+ethyl)ester which is insoluble but dispersible in water and an ethyl cellulose which is insoluble but dispersible in water in the weight ratio of 20:1 to 1:5, is presented, which is characterized by the fact that the coated granules are heated for at least 5 minutes at elevated temperatures ranging from between 50.degree. to 120.degree. C.
Claims22
A process for the manufacture of a granular delayod-release form of a pharmaceutically active substance, or mixtures thereof, wherein a granulated or crystalline pharmaceutically active substance, or mixtures thereof, is coated with a coating material mixture consisting essentially of a homogeneous mixture of a poly(H+meth)-acrylic acid-(methyl+ethyl) eater which is insoluble but dispersible in water and ethyl cellulose which is insoluble but dispersible in water in the weight ratio of 20:1 to 1:5, characterised in that the dry coated granules are then heated for at least 5 minutes at elevated temperature ranging from between 50.degree. to 120.degree. C. whereby the instant heat treated coated granules have improved storage stability, slower release of active substance, and release rate kinetics closer to zero order kinetics than identical granules not so heat treated.
A granular delayed-release form of a pharmaceutically active substance, or mixtures thereof, which is prepared by coating a granulated or crystalline pharmaceutically active substance, or mixtures thereof, with a coating material mixture consisting essentially of a homogeneous mixture of a poly(H+meth)-acrylic acid-(methyl+ethyl) ester which is insoluble but dispersible in water and an ethyl cellulose which is insoluble but dispersible in water in the weight ratio of 20:1 to 1:5, characterised in that the coated granules are heated for at least 5 minutes at elevated temperatures ranging from between 50.degree. to 120.degree. C. whereby the instant heat treated coated granules have improved storage stability, slower release of active substance, and release rate kinetics closer to zero order kinetics than identical granules not so heat treated.
Dependencies are inferred from the claim text.