Extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof

Inactive Publication Date: 2006-03-09
BOEHRINGER INGELHEIM INT GMBH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, it has proved difficult to formulate a tablet having a suitable combination of modified, extended or sustained-release and handling properties, where the drug is one having relatively high solubility, as in the case of pramipexole dihydrochlor

Method used

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  • Extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof
  • Extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof
  • Extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof

Examples

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example 1

[0107] One embodiment of the qualitative and quantitative composition of pramipexole extended release tablets according to the present invention is shown in Table 1.

TABLE 1Qualitative and Quantitative Composition ofPramipexole Extended Release Tabletmg per 0.75Reference toIngredientmg tabletFunctionStandardsPramipexole dihydrochloride0.750ActiveCorporatemonohydrate, peg-milledingredientstandardHypromellose 2208157.500SwellingPh.Eur. / USP(Methocel K 15 M)agentPregelatinized starch185.100FillerPh.Eur. / NF(Starch 1500)Carbomer 9413.500GellingPh.Eur. / NF(CARBOPOL ® 71 G)agentColloidal silicon dioxide1.400GlidantPh.Eur. / NFMagnesium stearate1.750LubricantPh.Eur. / NFTotal350.000

example 2

[0108] A further embodiment of the qualitative and quantitative composition of pramipexole extended release tablets according to the present invention is shown in Table 2.

TABLE 2Qualitative and Quantitative Compositionof Pramipexole Extended Release Tabletmg per 0.75Reference toIngredientmg tabletFunctionStandardsPramipexole dihydrochloride0.750ActiveCorporatemonohydrate, peg-milledingredientstandardHypromellose 2208157.500SwellingPh.Eur. / USP(Methocel K 15 M)agentPregelatinized starch174.600FillerPh.Eur. / NF(Starch 1500)Carbomer 94114.000GellingPh.Eur. / NF(CARBOPOL ® 71 G)agentColloidal silicon dioxide1.400GlidantPh.Eur. / NFMagnesium stearate1.750LubricantPh.Eur. / NFTotal350.000

example 3

[0109] The batch formula for the two pramipexole tablet formulations of Example 1 and 2 is shown in Table 3. The batch size of the final mixture corresponds to a batch size of 2000 tablets.

TABLE 3Composition per Batch of Pramipexole 0.75 mg ER TabletsGrams perGrams perbatchbatchIngredientExample 1Example 2Pramipexole dihydrochloride1.5001.500monohydrate, peg-milledHypromellose 2208315.000315.000Pregelatinized starch370.200349.200Carbomer 9417.00028.000Colloidal silicon dioxide2.8002.800Magnesium stearate3.5003.500Total Mass700.000700.000

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Abstract

An extended release tablet formulation comprising pramipexole or a pharmaceutically acceptable salt thereof in a matrix, the matrix comprising at least two water swelling polymers, wherein one of the polymers is pregelatinized starch, and wherein another one of the polymers is an anionic polymer.

Description

RELATED APPLICATIONS [0001] This application claims priority to European Application No. 04019248.6 filed Aug. 13, 2004, which is hereby incorporated by reference in its entirety. FIELD OF THE INVENTION [0002] The present invention is directed to an extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof, method for manufacturing the same, and use thereof. BACKGROUND OF THE INVENTION [0003] Pramipexole is a known dopamine D2 receptor agonist. It is structurally different from the ergot-derived drugs, e.g., bromocriptine or pergolide. It is also pharmacologically unique in that it is a full agonist and has receptor selectivity for the dopamine D2 family of dopamine receptors. [0004] Pramipexole is designated chemically as (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole and has the molecular formula C10H17N3S and a relative molecular mass of 211.33. The chemical formula is as follows: [0005] The salt form commonly used is p...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K9/28A61K31/428A61K31/4745
CPCA61K9/14A61K9/2027A61K9/2031A61K9/2054A61K31/428A61K9/2846A61K9/2866A61K9/2886A61K9/2059A61P25/00A61P25/14A61P25/16A61P25/28A61P43/00A61K9/20A61K9/28A61K31/4745
Inventor FRIEDL, THOMASEISENREICH, WOLFRAM
Owner BOEHRINGER INGELHEIM INT GMBH
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