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Immediate release 4-methyl-3-4[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-N-[5-(4-methyl-1H-imidazol-1-YL)-3-(trifluoromethyl)phenyl] benzamide formulation
US9301957B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-9301957-B2 |
| Application number | US-201414273874-A |
| Country | US |
| Kind code | B2 |
| Filing date | May 9, 2014 |
| Priority date | Nov 14, 2011 |
| Publication date | Apr 5, 2016 |
| Grant date | Apr 5, 2016 |
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Abstract
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A solid dosage form of nilotinib is disclosed that comprises: (i) a core comprising 4-Methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-N-[5-(4-methyl-1H-imidazol-1-yl)-3-(trifluoromethyl)phenyl]benzamide or a pharmaceutically acceptable salt thereof and excipients; and (ii) at least one polymer, said polymer coating said core, wherein disintegration of said solid dosage form is delayed.
First claim
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What is claimed: 1. A solid dosage form comprising: (i) a core comprising 4-Methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-N-[5-(4-methyl-1H-imidazol-1-yl)-3-(trifluoromethyl)phenyl]benzamide or a pharmaceutically acceptable salt thereof and excipients; and (ii) at least one polymer, said polymer coating said core, wherein disintegration of said solid dosage form is delayed 4-15 minutes, and wherein 7-13% of the solid dosage form is the polymer that coats the core. 2. The solid dosage form of claim 1 , wherein the polymer is hydroxypropylmethyl cellulose. 3. The solid dosage form of claim 1 , wherein 0-8% of the solid dosage form is dissolved after 5 minutes at pH 2.0. 4. The solid dosage form of claim 1 , wherein 45-60% of the solid dosage form is dissolved after 30 minutes at pH 2.0. 5. A solid dosage form comprising: (i) a core comprising 4-Methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-N-[5-(4-methyl-1H-imidazol-1-yl)-3-(trifluoromethyl)phenyl]benzamide or a pharmaceutically acceptable salt thereof and excipients; and (ii) at least one polymer, said polymer coating said core and wherein 7-13% of the solid dosage form is the polymer that coats the core, having a fasted state bioavailability equivalent to a hard gelatin capsule, wherein its C max and AUC are in the bioequivalent range when compared with capsules comprising 4-Methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-N-[5-(4-methyl-1H-imidazol-1-yl)-3-(trifluoromethyl)phenyl]benzamide or a pharmaceutically acceptable salt thereof. 6. The solid dosage form of claim 5 , wherein the polymer is hydroxypropylmethyl cellulose. 7. The solid dosage form of claim 5 , wherein 0-8% by weight of the solid dosage form is dissolved after 5 minutes at pH 2.0. 8. The solid dosage form of claim 5 , wherein 45-60% by weight of the solid dosage form is dissolved after 30 minutes at pH 2.0.
Assignees
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Classifications
Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose · CPC title
Tablet coating processes (mechanical aspects A61J3/06) · CPC title
- A61K31/506Primary
not condensed and containing further heterocyclic rings · CPC title
obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates · CPC title
Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose · CPC title
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- What does patent US9301957B2 cover?
- A solid dosage form of nilotinib is disclosed that comprises: (i) a core comprising 4-Methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-N-[5-(4-methyl-1H-imidazol-1-yl)-3-(trifluoromethyl)phenyl]benzamide or a pharmaceutically acceptable salt thereof and excipients; and (ii) at least one polymer, said polymer coating said core, wherein disintegration of said solid dosage form is delayed.
- Who is the assignee on this patent?
- Bhardwaj Upkar, Comfort Ann Reese, Li Ping, and 4 more
- What technology area does this patent fall under?
- Primary CPC classification A61K31/506. Mapped technology areas include Human Necessities.
- When was this patent published?
- Publication date Tue Apr 05 2016 00:00:00 GMT+0000 (Coordinated Universal Time) (B2). Legal status and post-grant events are not shown on this page.
- What related patents are in patentsdb?
- We list 8 related publications on this page (citations in our corpus or others sharing the same primary CPC).