Pramipexole orally disintegrating tablets and preparation method thereof

A technology of orally disintegrating tablets and pramipexole, which is applied in the preparation of orally disintegrating tablets of pramipexole, in the field of orally disintegrating tablets. Improve bioavailability, shorten dissolution time, and fully absorb the effect

Inactive Publication Date: 2009-04-08
BEIJING TRADE STAR MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, pramipexole tablets have been listed in the domestic market

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0033] Embodiment 1 Orally disintegrating tablet of pramipexole and preparation method thereof

[0034] Components:

[0035] Ingredients (raw and auxiliary materials) Dosage (weight percentage, %)

[0036] Pramipexole 0.5

[0037] Crospovidone 6

[0038] Microcrystalline Cellulose pH301 30

[0039] Lactose 30

[0040] Sucrose 25

[0041] Sodium Saccharin 2

[0042] Acrylic Eudragit L30D-55 5.5

[0043] Orange Flavor 1

[0044] Preparation:

[0045] Add pramipexole to the Eudragit L30D-55 suspension, add an appropriate amount of deionized water, stir evenly, add crospovidone, microcrystalline cellulose, lactose, sucrose, sodium saccharin and orange flavor in turn, while adding Stir, heat to 30-40°C, stir and mix for 1 hour to form a uniform suspension, pour into a suitable mold for freeze-drying, and seal and package after freeze-drying.

Example Embodiment

[0046] Embodiment 2 Orally disintegrating tablet of pramipexole and preparation method thereof

[0047] Components:

[0048] Ingredients (raw and auxiliary materials) Dosage (weight percentage, %)

[0049] pramipexole 1

[0050] Mannitol 10

[0051] Pregelatinized starch 10

[0052] Guar Gum 5

[0053] gum arabic 10

[0054] Erythritol 40

[0055] Microcrystalline Cellulose 14

[0056] Sucrose 9.8

[0057] Vanilla Flavor 0.2

[0058] Preparation:

[0059] Add pramipexole to the mixture of guar gum and gum arabic, add an appropriate amount of water, stir well, add mannitol, erythritol and sucrose, until it is completely dissolved, add pregelatinized starch, microcrystalline cellulose and vanilla The essence is added and stirred for 1 hour to form a uniform suspension, which is poured into a suitable mold for freeze-drying.

Example Embodiment

[0060] Embodiment 3 Orally disintegrating tablet of pramipexole and preparation method thereof

[0061] Components:

[0062] Ingredients (raw and auxiliary materials) Dosage (weight percentage, %)

[0063] pramipexole 1

[0064] Gelatin 20

[0065] Xylitol 18

[0066] Aspartame 4.9

[0067] Novagel RCN--15 50

[0068] Croscarmellose sodium 6

[0069] Peach Flavor 0.1

[0070] Preparation:

[0071] Suspend pramipexole, gelatin, xylitol, aspartame, croscarmellose sodium, and RCN-15 in water, stir for 1 hour to prepare a suspension, and pour it into a suitable mold In the process, freeze-drying is performed, and after the freeze-drying molding is completed, it is sealed and packaged.

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PUM

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Abstract

The invention relates to the technical field of pharmaceutical preparation, in particular to an orally disintegrating tablet containing pramipexole and a method for preparing the same, wherein the orally disintegrating tablet comprises effective amount of the pramipexole and a pharmaceutic adjuvant which is acceptable in pharmacy and can rapidly collapse and release drugs in an oral cavity. The orally disintegrating tablet containing the pramipexole has the advantages of faster action speed compared with the prior tablets and capsulated drugs, has convenient use and good taste in taking, and is more suitable for children, the elderly, and patients who can not swallow solid medicines.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing pramipexole, more specifically, the invention relates to a pramipexole orally disintegrating tablet. The invention also relates to a preparation method of the orally disintegrating pramipexole tablet. Background technique [0002] Pramipexole was developed by Boehringer Ingelheim in Germany. On May 10, 1997, the FDA approved Pramipexole for listing. The trade name was Mirapex, and it was jointly sold by Boehringer Ingelheim and Pharmacia in the United States. It is the first FDA-approved drug for Parkinson's in the past 6 years. [0003] Pramipexole is a non-ergot derivative, and its main advantages are: Pramipexole acts highly selectively on DA-2 receptors; it can be used alone to treat Parkinson's disease in the early stage, and it can be used in combination with dopamine to treat Parkinson's disease in the late stage At the same time, overseas studies on pramipexole for the treatment...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/428A61P25/16
Inventor 张耀春司成桃
Owner BEIJING TRADE STAR MEDICAL TECH
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