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Tamsulosin tablets

A technology of tamsulosin and tablet, applied in unit dosage form for treating or improving benign prostatic hyperplasia, the field of preparing tamsulosin tablet

Inactive Publication Date: 2007-02-07
SYNTHON BV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

While dry methods are generally well known, including direct compression and dry granulation techniques, such methods are considered unsuitable for dosage forms in which the active substance is used in an amount of less than 2% by weight, when less than 1% of the active substance is used Such methods are unacceptable when

Method used

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  • Tamsulosin tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] Three batches of monolithic tablets were prepared by step-blending and direct compression methods:

[0064] (％)

Tamsulosin Hydrochloride

0.4mg

0.5

anhydrous lactose

26.4mg

33.0

Dicalcium Phosphate Anhydrous

26.4mg

33.0

Hydroxypropyl Methyl Cellulose (HPMC)

26.4mg

33.0

Magnesium stearate

0.4mg

0.5

total

80mg

100

[0065] The difference from batch to batch is only the viscosity value of the selected hydroxypropyl methylcellulose:

[0066] Batch A contains METHOCEL K4M CR PREMIUM

[0067] Batch B contains METHOCEL K15M CR PREMIUM

[0068] Batch C contains METHOCEL K100M CR PREMIUM

[0069] b) Operation method

[0070] Tamsulosin hydrochloride was blended (15 minutes) with anhydrous lactose in a 1:9 ratio (10% active substance), ground (15 seconds) and then blended again (5 minutes). This pre-blend was then mixed with the remainder of the lactose,...

Embodiment 3

[0078] Tamsulosin Hydrochloride

Embodiment 4

[0080] Monolithic tablets prepared by dry compaction

[0081] Two batches of tablets were produced by a process involving compression, milling, blending and tabletting.

[0082] Batch 4a.: Compressed monolithic tablets, 6 mm diameter. Contains 33.0% METHOCEL K15M P.

[0083] Batch 4b. Compressed monolithic erodible sheet, 9mm diameter. Contains 13.2% METHOCEL K15MP.

[0084] Batch 4a

Batch 4b

Tamsulosin Hydrochloride

0.4mg

0.4mg

lactose

65.6mg

215.6 mg

Hydroxypropyl Methyl Cellulose (HPMC)

33.0mg

33.0mg

Magnesium stearate

1.0mg

1.0mg

total

100mg

250mg

[0085] b) Operation method

[0086] the batch

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PUM

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Abstract

The present invention relates to pharmaceutical tablets comprising low amounts of tamsulosim. The invention further relates to the manufacturing process and the therapeutic use of these compounds for the treatment of bening prostatic hyperplasia.

Description

Background of the invention [0001] The present invention relates to pharmaceutical tablets comprising tamsulosin, unit dosage forms prepared therefrom and methods of preparing the pharmaceutical tablets. [0002] Tamsulosin is the common name for 5-[2-[[2-(2-ethoxyphenoxy)ethyl]amino]propyl]-2-methoxy-benzenesulfonamide of the following formula (1) . [0003] [0004] It is disclosed in EP 34432 and US 4731478 as a pharmaceutically active substance having alpha-adrenergic blocking activity for the treatment of cardiac insufficiency and benign prostatic hyperplasia. [0005] The enantiomer (R)-Tamsulosin in hydrochloride form has been marketed in various countries, including the United States, for the treatment of symptoms of benign prostatic hyperplasia (also known as BPH), such as problems with urine output and frequency. The above-mentioned approved drug product is an oral capsule dosage form containing only 0.4 mg of tamsulosin hydrochloride. The capsules provide cont...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/18A61K9/20A61K9/48A61K9/28A61P13/08A61K9/26A61K47/02A61K47/04A61K47/12A61K47/26A61K47/32A61K47/38
CPCA61K9/2054A61K9/2009A61K31/18A61K9/2027A61K9/2846A61K9/2095A61K9/4808A61K9/2018A61P13/00A61P13/08A61P43/00A61P9/00A61K47/02
Inventor J·J·普拉图夫F·范达兰J·M·莱蒙斯
Owner SYNTHON BV
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