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Pramipexole sustained-release tablet and preparation method

A technology for pramipexole and sustained-release preparations, which is used in pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., and can solve the problem that the release is greatly affected by ionic strength.

Active Publication Date: 2021-03-02
BEIJING WBL PEKING UNIV BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] 3. The release is greatly affected by the ionic strength

Method used

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  • Pramipexole sustained-release tablet and preparation method
  • Pramipexole sustained-release tablet and preparation method
  • Pramipexole sustained-release tablet and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach

[0093] According to one embodiment, the sustained release formulation provided by the invention has the following components by weight percentage:

[0094]

[0095] According to another embodiment, the sustained release formulation provided by the invention has the following components by weight percentage:

[0096]

[0097] According to another embodiment, the sustained release formulation provided by the invention has the following components by weight percentage:

[0098]

[0099] According to another embodiment, the sustained release formulation provided by the invention has the following components by weight percentage:

[0100]

[0101] According to another embodiment, the sustained release formulation provided by the invention has the following components by weight percentage:

[0102]

[0103] According to another embodiment, the sustained release formulation provided by the invention has the following components by weight percentage:

[0104]

[01...

Embodiment 1

[0141] prescription:

[0142]

[0143] Process:

[0144] 1. Mix pramipexole with micropowder silica gel, magnesium stearate, carbomer, and HPMC in equal amounts until it reaches 10% of the total weight of the prescription;

[0145] 2. Sieve the mixture through a 60-mesh sieve for 3 times;

[0146] 3. Add the remaining excipients and mix well;

[0147] 4. Tablet pressing.

[0148] The release results of different pH media are shown in Figure 2.

[0149] The slow release effect can be achieved at different pH values, the moldability is good, the surface is smooth, and the moisture is less than 2.5%, which is significantly lower than about 6% of commercially available preparations.

Embodiment 2

[0151] prescription:

[0152]

[0153] Process:

[0154] 1. Mix pramipexole with micropowder silica gel, magnesium stearate, carbomer, and HPMC in equal amounts until it reaches 10% of the total weight of the prescription;

[0155] 3. Sieve the pre-mixture through a 60-mesh sieve for 3 times;

[0156] 4. Add the remaining excipients and mix well;

[0157] 5. Tablet pressing.

[0158] The release results of the pH6.8 medium are shown in Figure 3.

[0159] The release in pH6.8 media slowed down with the increase of carbomer dosage.

[0160] The release results in water are shown in Figure 4.

[0161] The results of release in water show that the amount of carbomer in the prescription increases and the release in water is less, but all are significantly higher than commercially available preparations (batch number: 308044D specification: 0.375mg), that is, the prescription of the present invention is weaker than the commercially available preparations under the influence ...

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Abstract

The invention relates to a sustained-release pramipexole tablet and a preparation method thereof. The sustained-release pramipexole tablet comprises, by weight, 0.05 to 3% of pramipexole or a salt thereof, 55 to 85% of a water-swelling framework material, 10 to 40% of a water-insoluble framework material and a proper amount of other excipients, wherein the weight percentages of the above components sum to 100%.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a pramipexole sustained-release tablet, its preparation method and application. Background technique [0002] pramipexole known as dopamine D 2 receptor agonists. It is structurally distinct from ergot-derived drugs such as bromocriptine or pergolide. It is a full agonist of dopamine, and the D of dopamine 2 Family receptors are selective. The chemical name of pramipexole is: (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole, the molecular formula is C 10 h 17 N 3 S, the relative molecular weight is 211.33. The chemical formula is as follows: [0003] [0004] The commonly used pramipexole salt is pramipexole dihydrochloride monohydrate (molecular formula C 10 h 17 N 3 S 2HCl H 2 O; relative molecular weight 302.27). Pramipexole dihydrochloride monohydrate is white to yellow-white, odorless, crystalline powder. Melting occurs at 29...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/22A61K47/32A61K47/38A61K47/44A61K47/12A61K31/428A61P25/16
CPCA61K9/2013A61K9/2027A61K9/2054A61K31/428
Inventor 郭树仁彭博樊利青潘健腾薛兰王茹萍
Owner BEIJING WBL PEKING UNIV BIOTECH
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