Delayed release pharmaceutical composition of duloxetine

A technology of duloxetine and composition, which is applied in the field of duloxetine sustained-release pharmaceutical composition, and can solve problems such as difficulties in enteric-coated preparations with drug loading

Inactive Publication Date: 2011-01-05
ALPHAPHARM PTY LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Further, it was found to be particularly difficult to prepare enteric formulations with higher drug loadings that did not allow some release of duloxetine in an acidic environment, which would create a problem for the release of the drug in the stomach. Likelihood or probability, contrary to the desired method of administration

Method used

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  • Delayed release pharmaceutical composition of duloxetine
  • Delayed release pharmaceutical composition of duloxetine
  • Delayed release pharmaceutical composition of duloxetine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0112] The following examples relate to hard gelatin capsules containing a tablet core composition prepared by standard wet granulation techniques. The capsule exemplifies a single 60 mg dose of duloxetine and contains 3 unit dosage forms in the form of tablets compressed at 50 mg each and each tablet contains 20 mg of duloxetine in hydrochloride form . The data in the following examples refer to the combined values ​​of the three tablets in the capsule. It will of course be understood that the number of unit dosage forms and the actual effective amount in each unit dosage form may vary according to dosage requirements. For example a 20 mg dose of duloxetine may be formed in capsules, a single unit dosage form containing 20 mg duloxetine or an equivalent amount of a pharmaceutically acceptable salt, or two unit dosage forms each containing 10 mg duloxetine.

[0113]

[0114]

[0115]

[0116]

[0117] The following examples relate to duloxetine hydrochloride coat...

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Abstract

A pharmaceutical composition comprising duloxetine or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipient(s) characterised in that the duloxetine has a D90 particle size of 2 to 40 [mu]m.

Description

technical field [0001] The present invention relates to a pharmaceutical composition comprising duloxetine or a pharmaceutically acceptable salt thereof having a defined particle size, a process for the preparation of said composition and a therapeutic use of said composition. The present invention further relates to duloxetine or any pharmaceutically acceptable salt thereof having a defined particle size. Background of the invention [0002] Duloxetine, chemical name (+)-N-methyl-3-(1-naphthyloxy)-3-(2-thienyl)propylamine, has the structure (I) shown below and is a double 5- Serotonin and norepinephrine reuptake inhibitors (SNRIs). It is sold by Eli Lilly & Co in the form of the hydrochloride salt under the tradename Marketed for the treatment of major depressive episodes, stress urinary incontinence and diabetic peripheral neuropathic pain. [0003] [0004] Duloxetine and methods for its preparation are disclosed in documents such as US Patent No. 5,023,269, Europe...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/381A61K9/52A61P25/24A61P25/02A61P29/00
CPCA61K9/2886A61K9/2866A61K31/381A61P25/00A61P25/02A61P25/04A61P25/24A61P29/00
Inventor 布莱特·安东尼·穆尼帕纳吉奥塔斯·克莱米达斯菲利普·约翰·费尔库桑
Owner ALPHAPHARM PTY LTD
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