Pharmaceutical processing
AssigneeDrug Delivery International Ltd.
InventorsHoward Norman Ernest Stevens, Alexander Balfour Mullen, Vivekanand Bhardwaj, Fiona Jane MacDougall, David Smith
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Abstract
A method for making a controlled release material, comprising the steps of: — (a) forming granules comprising one or more wax and one or more disintegrant; (b) spheronisation of the granules and (c) compaction of the spheronised granules of step so as to form the controlled release material. The invention also relates to a tablet and delayed and sustained release material made according to the method.
Claims11
A method for making an erodible controlled release tablet, comprising:
- (a) forming granules comprising 20 to 80% by weight of one or more waxes and 12-50% by weight of one or more disintegrants, wherein the one or more waxes are insoluble in water, and wherein the granules are formed by mixing the one or more disintegrants and the one or more waxes, in molten form, to form a mixture, whilst retaining the one or more waxes in molten form, and solidifying the mixture by cooling below melting point whilst mixing to form the granules;
- (b) spheronising the granules;
- and
- (c) compacting the spheronised granules around a core tablet comprising an Active Pharmaceutical Ingredient to form a controlled release barrier layer.
A tablet comprising a core and a first layer encapsulating the core, wherein the first layer is an erodible controlled release barrier layer comprising compacted spheronized granules comprising 20 to 80% by weight of one or more waxes and 12-50% by weight of one or more disintegrants;
- wherein the one or more waxes is insoluble in water;
- wherein the tablet is formed via the steps comprising:
- (a) forming granules comprising 20 to 80% by weight of one or more waxes and 12-50% by weight of one or more disintegrants, wherein the one or more waxes is are insoluble in water, and wherein the granules are formed by mixing the one or more disintegrants and the one or more waxes, in molten form, to form a mixture, whilst retaining the one or more waxes in molten form, and solidifying the mixture by cooling below melting point whilst mixing to form the granules;
- (b) spheronising the granules;
- and
- (c) compacting the spheronised granules around a core tablet comprising an Active Pharmaceutical Ingredient to form a controlled release barrier layer.
Dependencies are inferred from the claim text.