Patent ID: 9381198
Filing Date: 2016-07-05
CPC Classification: A61K,A61L,A61P,C07D

Claim Text:
1. A pharmaceutical composition in unit dosage form comprising: (a) a solid support core of substantially water soluble, swellable or insoluble material comprising one or a plurality of spheroid granules, pellets or beads; (b) a substrate layer comprising a binder and microparticles of anagrelide hydrochloride monohydrate in hydrated crystal form in an amount that is equivalent to from about 100 μg to about 1000 μg of anagrelide free base, wherein at least 90% of the microparticles are 25 microns or less, and the binder is present at about 2-4% by weight of the composition; (c) a seal coat layer comprising a substantially water-soluble polymer, wherein the seal coat is present at about 1-5% by weight of the composition; and (d) a release control component comprising a water insoluble polymer and a plasticizer, wherein the release control component is present at about 1-5% by weight of the composition; wherein the seal coat layer is disposed between the substrate layer and the release control component and reduces chemical interaction between the anagrelide hydrochloride monohydrate in the substrate layer and the plasticizer in the release control component, and the anagrelide hydrochloride monohydrate in the composition has a shelf stability of at least three months.