Salts and solid forms of (S)-3-(4- (4-(morpholinomethyl)benzyl)oxy)-1-oxoisoindolin-2-yl)piperidine-2,6-dione and compositions comprising and methods of using the same
US-9221788-B2 · Dec 29, 2015 · US
US9757355B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-9757355-B2 |
| Application number | US-201213978869-A |
| Country | US |
| Kind code | B2 |
| Filing date | Jan 9, 2012 |
| Priority date | Jan 10, 2011 |
| Publication date | Sep 12, 2017 |
| Grant date | Sep 12, 2017 |
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Provided herein are controlled release oral dosage forms of poorly soluble drugs, methods of making the dosage forms, and methods of their use for the treatment of various diseases and/or disorders.
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What is claimed is: 1. An oral dosage form consisting of about 9% by weight of a compound of formula (I): or a pharmaceutically acceptable salt thereof, about 34% by weight of mannitol, about 5% by weight of sodium croscarmellose, about 1% by weight of calcium stearate and about 51% by weight of polyvinylpyrrolidone-vinylacetate copolymer. 2. The oral dosage form of claim 1 , wherein the oral dosage form is prepared by the following process: (i) blend the compound of formula (I) with hydroxypropyl methylcellulose or polyvinylpyrrolidone-vinylacetate copolymer; (ii) process the blended product of (i) by hot melt extrusion at 190° C.; (iii) mill the extruded product of (ii) using 18 mesh screen; (iv) blend the milled extrudate of (iii) with prescreened crosscarmellose sodium and mannitol; (v) blend the product of (iv) with prescreened calcium stearate; and (vi) encapsulate the blended product of (v). 3. The oral dosage form of claim 2 , wherein the blending of steps (i) and (iv) is for 460 rotations each using a shaker mixer. 4. The oral dosage form of claim 2 , wherein the blending of step (v) is for 75 rotations using a shaker mixer. 5. The oral dosage form of claim 2 , wherein a semi-automatic encapsulator is used in step (vi).
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