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Pramipexole dihydrochloride sustained-release tablet composition and preparation method thereof

A technology for pramipexole hydrochloride and sustained-release tablets, applied in the field of pramipexole hydrochloride sustained-release tablets and their preparation, can solve the problems of unqualified content uniformity, incomplete late release, insufficient prescription stability, etc. Good fluidity, stable drug release behavior, stable and controllable release behavior

Active Publication Date: 2016-04-06
JIANGSU SHENLONG PHARMA +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since pramipexole hydrochloride is an easily soluble compound, it has been verified by experiments that the dosage of ethyl cellulose and hydroxypropyl methylcellulose must account for more than 30% of the prescription in order to effectively control the release rate of the main drug. When cellulose exceeds 40% of the prescribed amount, it will cause delayed drug release or incomplete late release
On the one hand, more sustained-release excipients are used for direct powder compression; on the other hand, the dosage range of ethyl cellulose as the main sustained-release excipient is strict, and the amount of diluent used is too small. The proportion of pramipexole hydrochloride is 0.1%~1.5%. Low-dose and low-content drugs will cause insufficient stability of the formulation, and there is a risk of unqualified content uniformity and standard deviation (RSD) of in vitro release, which may cause quality differences between batches

Method used

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  • Pramipexole dihydrochloride sustained-release tablet composition and preparation method thereof
  • Pramipexole dihydrochloride sustained-release tablet composition and preparation method thereof
  • Pramipexole dihydrochloride sustained-release tablet composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Prescription (measured per tablet):

[0044]

[0045] Pretreatment: pass the active ingredient, acrylic resin, hydroxypropyl methylcellulose, and pregelatinized starch through an 80-mesh sieve for later use;

[0046] Pre-mixing: step (1) treated pramipexole hydrochloride and pregelatinized starch are mixed in equal amounts;

[0047] Total mixing: hydroxypropyl methylcellulose, acrylic resin, colloidal silicon dioxide and the mixture in step (2) are passed through a 40-mesh sieve and mixed twice, then three-dimensionally mixed for 15 minutes, and then magnesium stearate is added and mixed for 3 minutes to obtain the total mixture;

[0048] Tablet compression: the total mixture obtained in step (3) is compressed into tablets to prepare sustained-release tablets, tablet hardness 5kg / cm 2 ~18kg / cm 2 .

Embodiment 2

[0050] Prescription (measured per tablet):

[0051]

[0052] Pretreatment: pass the active ingredient, acrylic resin, hydroxypropyl methylcellulose, and pregelatinized starch through an 80-mesh sieve for later use;

[0053] Pre-mixing: step (1) treated pramipexole hydrochloride and pregelatinized starch are mixed in equal amounts;

[0054] Total mixing: hydroxypropyl methylcellulose, acrylic resin, colloidal silicon dioxide and the mixture in step (2) are passed through a 40-mesh sieve and mixed twice, then three-dimensionally mixed for 15 minutes, and then magnesium stearate is added and mixed for 3 minutes to obtain the total mixture;

[0055] Tablet compression: the total mixture obtained in step (3) is compressed into tablets to prepare sustained-release tablets, tablet hardness 5kg / cm 2 ~18kg / cm 2 .

Embodiment 3

[0057] Prescription (measured per tablet):

[0058]

[0059] Pretreatment: pass the active ingredient, acrylic resin, hydroxypropyl methylcellulose, and pregelatinized starch through an 80-mesh sieve for later use;

[0060] Pre-mixing: step (1) treated pramipexole hydrochloride and pregelatinized starch are mixed in equal amounts;

[0061] Total mixing: hydroxypropyl methylcellulose, acrylic resin, colloidal silicon dioxide and the mixture in step (2) are passed through a 40-mesh sieve and mixed twice, then three-dimensionally mixed for 15 minutes, and then magnesium stearate is added and mixed for 3 minutes to obtain the total mixture;

[0062] Tablet compression: the total mixture obtained in step (3) is compressed into tablets to prepare sustained-release tablets, tablet hardness 5kg / cm 2 ~18kg / cm 2 .

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Abstract

The invention provides a pramipexole dihydrochloride sustained-release tablet composition and a preparation method thereof. The composition comprises the following components by weight: 0.1%-1% of pramipexole dihydrochloride, 10%-40% of hydroxypropyl methyl cellulose, 25%-50% of polyacrylic acid resin, 20-60% of pregelatinized starch, 0.3%-1.5% of colloidal silicon dioxide and 0.5%-1% of magnesium stearate.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a pramipexole hydrochloride sustained-release tablet and a preparation method thereof. Background technique [0002] Pramipexole is an anti-Parkinson's disease drug developed by Boehringer Ingelheim in Germany. It is a dopamine D2 receptor agonist with a chemical name of (S)-2-amino-4,5,6,7- Tetrahydro-6-propylamine-benzothiazole, molecular formula C 10 h 17 N 3 S and its relative molecular mass are 211.32, and its chemical structural formula is as follows: [0003] . [0004] The commonly used solvate form is pramipexole dihydrochloride monohydrate (molecular formula: C10H21Cl2N3OS; relative molecular mass: 302.27). Pramipexole dihydrochloride monohydrate is a highly soluble compound with a water solubility greater than 20mg / ml. Solubility in buffered media from pH 2.0 to pH 7.4 is generally higher than 10 mg / ml. Pramipexole dihydrochloride monohydrate is non-h...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/428A61K47/38A61K47/32A61P25/16
Inventor 秦勇康振华陈远东徐成游剑蔡雄
Owner JIANGSU SHENLONG PHARMA
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