Pramipexole dihydrochloride pharmaceutical composition and preparation method thereof

A technology of pramipexole hydrochloride and copolymer, which is applied in the field of pramipexole hydrochloride orally dissolving film pharmaceutical composition and its preparation, can solve the strict requirements of packaging, storage and transportation, complex preparation process of orally disintegrating tablets, Solve the problems of low tablet hardness, achieve the effect of low cost, good for personnel health protection, and not easy to be brittle

Pending Publication Date: 2021-03-30
SICHUAN KELUN PHARMA RES INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the preparation process of orally disintegrating tablets is more complicated, usually requires more special production equipment and production conditions, and the cost is high...

Method used

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  • Pramipexole dihydrochloride pharmaceutical composition and preparation method thereof
  • Pramipexole dihydrochloride pharmaceutical composition and preparation method thereof
  • Pramipexole dihydrochloride pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0081] Prescription composition (make 1000 tablets)

[0082] Composition of raw materials Dosage (g) pramipexole hydrochloride 0.1 polyvinyl alcohol 12.77 Crospovidone 3 polyethylene glycol 400 2 glycerin 1 Sucralose 0.1 orange flavor 1 sunset yellow 0.03 Unit film weight (total) 20

[0083] Preparation Process

[0084] (1) Heat polyvinyl alcohol in 100-130 g of purified water to 75-85° C., stir to dissolve, leave to cool to room temperature to replenish volatile water, and obtain solution I;

[0085] (2) Dissolving pramipexole hydrochloride, polyethylene glycol 400, glycerin, sucralose, and orange essence in solution I to obtain solution II;

[0086] (3) Add crospovidone and sunset yellow to solution II and stir to mix evenly to obtain matrix solution III, and vacuumize -0.05Mpa—-0.08Mpa to remove air bubbles for more than 20 minutes, and control the solid content to 15-20 %;

[0087] (4) Apply matrix sol...

Embodiment 2

[0090] Prescription composition (make 1000 tablets)

[0091] Composition of raw materials Dosage (g) pramipexole hydrochloride 0.25 Polyvinyl alcohol-polyethylene glycol graft copolymer 16 Crospovidone 4 microcrystalline cellulose 13 polyethylene glycol 400 3 glycerin 2 Sucralose 0.11 orange flavor 1.6 sunset yellow 0.04 Unit film weight (total) 40

[0092] Preparation Process

[0093] (1) Heat the polyvinyl alcohol-polyethylene glycol graft copolymer in 160-200g of purified water to 75-85°C, stir to dissolve, leave to cool to room temperature to replenish the volatile water, and obtain solution I;

[0094] (2) Dissolving pramipexole hydrochloride, polyethylene glycol 400, glycerin, sucralose, and orange flavor in solution I to obtain solution II;

[0095] (3) Add crospovidone, microcrystalline cellulose, and sunset yellow into solution II and stir and mix evenly to obtain matrix liquid III, and remove...

Embodiment 3

[0099] Prescription composition (make 1000 tablets)

[0100]

[0101]

[0102] Preparation Process

[0103] (1) Heat polyvinyl alcohol in 200-240g of purified water to 75-85°C, stir to dissolve, leave to cool to room temperature to supplement the volatilized water, and obtain solution I;

[0104] (2) Dissolving pramipexole hydrochloride, polyethylene glycol 400, glycerin, sucralose, and orange flavor in solution I to obtain solution II;

[0105] (3) Add crospovidone, microcrystalline cellulose, and sunset yellow into solution II and stir and mix evenly to obtain matrix liquid III, and remove air bubbles for more than 20 minutes under vacuum-0.05Mpa—-0.08Mpa conditions, and control solid The content is 25-30%;

[0106] (4) Coat the matrix solution III with a coating machine, control the coating wet thickness to 200-250um, and dry and roll at 60-75°C;

[0107] (5) Cut the winding film, the cutting width of the film is: 2×4cm 2 , the control stresses the difference ± 6%, ...

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PUM

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a pramipexole dihydrochloride oral film-dissolving agent pharmaceutical composition and a preparation method thereof. The composition provided by the invention comprises a polymer film-forming material, a plasticizer and the like. The film agent does not need to be taken with water, is convenient to take, good in taste and rapid to dissolve out, is very suitable for Parkinson's disease patients, especially patients suffering from chewing, dysphagia and hand tremor, greatly improves the compliance of the patients, and has good economic benefits and social benefits.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a pramipexole hydrochloride orally dissolving film pharmaceutical composition and a preparation method thereof. Background technique [0002] Pramipexole hydrochloride (Pramipexole) is a new generation of non-ergot dopamine receptor agonist developed by Boehringer Ingelheim, Germany. It can highly selectively act on dopaminergic D2 and D3 receptors, stimulate the release of dopamine in the brain, and improve motor symptoms. It is the first-line drug for the treatment of Parkinson's disease. [0003] The chemical name of pramipexole is S-2-amino-4,5,6,7-tetrahydro-6-(propylamino)-benzothiazole, molecular formula C 10 h 17 N 3 S, relative molecular weight 211.33. Pramipexole hydrochloride is white or off-white crystalline powder, easily soluble in water, soluble in methanol, insoluble or slightly soluble in ethanol, almost insoluble in dichloromethane, very stable in ...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K47/10A61K47/32A61K47/34A61K47/38A61K31/428A61P25/16
CPCA61K9/006A61K47/32A61K47/34A61K47/38A61K31/428A61P25/16A61K9/7007
Inventor 徐飞邹笑一赵栋王晶翼
Owner SICHUAN KELUN PHARMA RES INST CO LTD
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