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|Abstract:||Controlled release preparation containing a number of insoluble beads applied with one or more pharmaceutically active compounds, a method for the production thereof and the use in a treatment where a controlled release of a pharmaceutically active compound is needed.|
|Inventor(s):||Dahlinder; Lars-Erik D. (Molndal, SE), Johansson; Mats O. (Goteborg, SE), Sandberg; John A. (Molndal, SE), Sjogren; John A. (Molnlycke, SE)|
|Assignee:||Aktiebolaget Hassle (Molndal, SE)|
1. Controlled release beads, each comprising a compact inert core consisting of a plastic resin selected from the group consisting of polypropylene and polyethylene; an active layer
applied to the surface of the insoluble core consisting essentially of one or more pharmaceutically active compounds; and a release controlling polymeric membrane covering the active layer.
2. Beads according to claim 1 wherein the core has a size of 0.1-2 mm and the combination of the core and the layer has a size of 0.2-3.0 mm.
3. Beads according to claim 2, wherein the core has a size of 0.1-0.5 mm and the combination of the core and the active layer has a size of 0.3-1.0 mm.
4. Beads according to claim 1 wherein the pharmaceutically active compound is to be administered orally or parenterally.
5. Beads according to claim 1 wherein the pharmaceutically active compound is used in the cardiovascular, gastrointestinal or chemotherapeutic field.
6. Beads according to claim 1 wherein the pharmaceutically active compound is selected from the group consisting of a salt of an adrenergic beta-blocking agent, an antibiotic and a gastric acid secretion inhibitor.
7. A process for the preparation of beads for use in controlled release products consisting essentially of
(a) dissolving a pharmaceutically active compound in a solvent;
(b) applying the dissolved active compound to an insoluble core consisting of a plastic resin selected from the group consisting of polypropylene and polyethylene having a size of 0.2 to 2.00 mm;
(c) drying the insoluble core to remove the solvent and form beads having a coating of active compound and a size of 0.2 to 3.0 mm; and
(d) further coating the beads with a release controlling polymeric membrane.
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