Pramipexole hydrochloride sustained-release tablet composition and preparation method thereof

A technology for pramipexole hydrochloride and sustained-release tablets, which is applied in the field of pramipexole hydrochloride sustained-release tablets and its preparation, can solve problems such as unqualified content uniformity, insufficient prescription stability, and incomplete release in the later period, and achieve Good fluidity, stable and controllable release behavior, and stable drug release behavior

Active Publication Date: 2019-11-05
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 hydrochloride sustained-release tablet composition and preparation method thereof
  • Pramipexole hydrochloride sustained-release tablet composition and preparation method thereof
  • Pramipexole hydrochloride sustained-release tablet composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Prescription (based on each tablet):

[0044]

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

[0046] Pre-mixing: Step (1) The processed pramipexole hydrochloride is mixed with pregelatinized starch in equal amounts;

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

[0048] Tableting: tableting the total mixture obtained in step (3) to prepare a sustained-release tablet with a tablet hardness of 5kg / cm 2 ~18kg / cm 2 .

Embodiment 2

[0050] Prescription (based on each tablet):

[0051]

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

[0053] Pre-mixing: Step (1) The processed pramipexole hydrochloride is mixed with pregelatinized starch in equal amounts;

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

[0055] Tableting: tableting the total mixture obtained in step (3) to prepare a sustained-release tablet with a tablet hardness of 5kg / cm 2 ~18kg / cm 2 .

Embodiment 3

[0057] Prescription (based on each tablet):

[0058]

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

[0060] Pre-mixing: Step (1) The processed pramipexole hydrochloride is mixed with pregelatinized starch in equal amounts;

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

[0062] Tableting: tableting the total mixture obtained in step (3) to prepare a sustained-release tablet with a tablet hardness of 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, and specifically relates 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, Germany. It is a dopamine D2 receptor agonist with the chemical name (S)-2-amino-4,5,6,7- Tetrahydro-6-propylamine-benzothiazole, molecular formula is C 10 H 17 N 3 S and relative molecular mass is 211.32, and the chemical structure 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. The solubility in buffer media from pH 2.0 to pH 7.4 is usually higher than 10 mg / ml. Pramipexole dihydrochloride monohydrate is non-hygroscopic and h...

Claims

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Application Information

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Patent Type & Authority Patents(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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