Composition for treatment of essential thrombocythemia
The present invention relates to a novel pharmaceutical composition free of gastric coating comprising anagrelide hydrochloride in combination with a non-pH dependent polymer and a pharmaceutically acceptable water soluble acid and its use for the treatment of essential thrombocythemia.
1. A pharmaceutical composition free of gastric coating comprising anagrelide HCl having a mean particle size of 5 μm in an amount of between 2 mg and 3 mg, poylacrylacid, and citric acid in an amount of between 15 mg and 19 mg, wherein the amount of the polyacrylacid is between 1.5 and 2.5 fold of the anagrelide (w/w).
2. The pharmaceutical composition according to claim 1 , further comprising microcrystalline cellulose.
3. The pharmaceutical composition according to claim 2 , wherein the microcrystalline cellulose is present in an amount of between 10 mg and 150 mg.
4. The pharmaceutical composition according to claim 1 having an in-vitro release rate of at least 45% within 8 hours.
5. The pharmaceutical composition according to claim 1 , comprising anagrelide HCl, a polyacrylacid, citric acid, microcrystalline cellulose and magnesium stearate.
6. The pharmaceutical composition according to claim 1 , wherein the pharmaceutical composition is in the form of a tablet.
7. The pharmaceutical composition according to claim 1 , wherein the polyacrylacid is present in an amount of between 3 and 4 mg.
8. The pharmaceutical composition according to claim 3 , wherein the microcrystalline cellulose is present in an amount of between 70 mg and 80 mg.
9. A method of treating essential thrombocythemia, comprising administering to a patient in need thereof the pharmaceutical composition of claim 1 .