Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

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
View PDF10 Cites 0 Cited by
  • 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

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • 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 .

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

PropertyMeasurementUnit
hardnessaaaaaaaaaa
hardnessaaaaaaaaaa
Login to View More

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

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
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
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com