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Imatinib compositions

A technology of composition and mixture, applied in the field of imatinib composition

Inactive Publication Date: 2011-01-19
TEVA PHARMA IND LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Imatinib mesylate is considered soluble in aqueous buffers with a pH less than or equal to 5.5, but very slightly soluble to insoluble in neutral / basic aqueous buffers

Method used

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  • Imatinib compositions
  • Imatinib compositions
  • Imatinib compositions

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0082] Example 1: Preparation of imatinib solid solution.

[0083] A 1:1 (w / w) solid solution of imatinib mesylate in povidone was prepared by dissolving povidone in ethanol and adding imatinib mesylate to the resulting solution / mixture . A solid solution of imatinib in povidone was prepared by evaporation of ethanol.

[0084] production process

[0085] 1) Dissolve 1 gram of povidone (PVP K-30) in 100 grams of ethanol in a suitable container.

[0086] 2) 1 gram of imatinib mesylate raw material was dissolved in the solution obtained in step 1.

[0087] 3) Evaporate the solvent from the solution (at a temperature of 55°C) using a rotary evaporation for 30-50 minutes.

[0088] 4) Collect the obtained solid solution from the container.

Embodiment 2

[0089] Embodiment 2: Preparation of imatinib solid solution.

[0090] A 1:2 solid solution of imatinib mesylate in povidone was prepared by dissolving povidone in ethanol and adding imatinib mesylate to the resulting solution / mixture. A solid solution of imatinib mesylate in povidone was prepared by evaporating ethanol.

[0091] production process

[0092] 1) Dissolve 2 grams of povidone (PVP K-30) in 100 grams of ethanol in a suitable container.

[0093] 2) 1 gram of imatinib mesylate raw material was dissolved in the solution obtained in step 1.

[0094] 3) Evaporate the solvent from the solution (at a temperature of 55°C) using a rotary evaporation for 30-50 minutes.

[0095] 4) Collect the obtained solid solution from the container ( figure 2 ).

Embodiment 3

[0097] Example 3: A formulation comprising a solid solution of imatinib (imatinib:PVP 1:0.5).

[0098] A formulation comprising the following excipients and a solid solution of imatinib mesylate (imatinib:PVP 1:0.5) was prepared. This formulation was prepared by direct compression of a mixture of the following materials.

[0099]

[0100] Magnesium stearate

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Abstract

Provided are compositions of imatinib, methods for their preparation, and methods for treatment using the same.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to US Provisional Patent Application 60 / 841,707, filed September 1, 2006, the contents of which are incorporated herein by reference. technical field [0003] The present invention relates to compositions of imatinib, methods for their preparation, and methods of treatment using them. Background technique [0004] Imatinib, from mesylate or 4-[(4-methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridyl) -2-Pyrimidinyl]amino]-phenyl]benzamide mesylate is exemplified and has the following chemical structure: [0005] [0006] It is reported as a white to off-white to brown or yellowish crystalline powder. Imatinib mesylate is believed to be soluble in aqueous buffers with a pH of less than or equal to 5.5, but very slightly soluble to insoluble in neutral / basic aqueous buffers. In non-aqueous solvents, the drug substance is remarkably soluble to very slightly soluble in dimethylsu...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K9/20A61K31/506
CPCA61K31/506A61K9/2054A61K9/146A61K9/2018A61K9/2059
Inventor I·扎利特B·帕尔
Owner TEVA PHARMA IND LTD
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