Manufacture of oral dosage forms delivering both immediate...

A - Human Necessities – 61 – K

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Details

A61K 9/22 (2006.01) A61K 9/20 (2006.01) A61K 9/24 (2006.01) A61K 31/155 (2006.01) A61K 31/4015 (2006.01) A61K 45/06 (2006.01)

Patent

CA 2417686

A method is disclosed for manufacturing a pharmaceutical tablet for oral administration, the tablet combining both immediate-release and prolonged- release modes of drug delivery and using an immediate-release drug that is either insoluble in water or only sparingly soluble and is present in a very small amount compared to the prolonged-release drug. The method involves the use of particles of the immediate-release drug that are equal to or less than 10 microns in diameter, applied as a layer or coating over a core of the prolonged-release drug, the layer or coating being either the drug particles themselves, applied as an aqueous suspension, or a solid mixture containing the drug in admixture with a material that disintegrates rapidly in gastric fluid. The result in both cases is a high degree of uniformity in the proportions of the immediate-release and prolonged-release drugs, uniformity that is otherwise difficult to achieve in view of the insolubility of the immediate- release drug and its relatively small amount compared to the prolonged- released drug.

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