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A kind of 5-HT receptor agonist orally disintegrating tablet and preparation method thereof

A technology for orally disintegrating tablets and drugs, which is applied in pill delivery, pharmaceutical formulations, medical preparations with non-active ingredients, etc. It can solve the problems of gritty feeling, affecting the patient's taste and compliance, and slow disintegration of preparations.

Active Publication Date: 2015-09-30
BEIJING QUANTUM HI TECH PHARMA TECHCO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In China, the preparation technology of orally disintegrating tablets started relatively late. At present, the direct compression method is mostly used to prepare orally disintegrating tablets. Most disintegrants are insoluble in water, so the orally disintegrating tablets prepared by this method often have a gritty feeling after tasting, which affects the taste and compliance of patients when taking it; and the disintegration of the preparation will be very slow

Method used

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  • A kind of 5-HT receptor agonist orally disintegrating tablet and preparation method thereof
  • A kind of 5-HT receptor agonist orally disintegrating tablet and preparation method thereof
  • A kind of 5-HT receptor agonist orally disintegrating tablet and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0152] The preparation formula of the present invention is made up of following components:

[0153] Zolmitriptan 2.50g

[0154] Mannitol 7.00g

[0155] Pullulan 9.00g

[0156] Xanthan gum 0.06g

[0157] Acesulfame K 0.50g

[0158] Mint essence 0.20g

[0159] Purified water 180.74g

[0160] A total of 1000 pieces were made.

[0161] The specific preparation method is as follows: Zolmitriptan, mannitol, pullulan, acesulfame potassium, and peppermint essence are added to the fully dissolved xanthan gum solution, and mixed to form a homogeneous solution; After degassing, pour it into the mold accurately; pre-freeze at -40°C to -170°C for 1 to 60 minutes, then transfer it to a freeze dryer, under the conditions of 0.01mbar to 10mbar and -30°C to 30°C Freeze-dry for 1-10 hours to obtain zolmitriptan orally disintegrating tablets of the present invention; in the above method, after the pre-freezing step, before transferring to the lyophilizer, an ice crystal incubation step c...

Embodiment 2

[0163] The preparation formula of the present invention is made up of following components:

[0164] Zolmitriptan 2.50g

[0165] Glycine 7.00g

[0166] Pullulan 9.00g

[0167] Xanthan gum 0.06g

[0168] Acesulfame K 0.50g

[0169] Mint essence 0.20g

[0170] Purified water 180.74g

[0171] A total of 1000 pieces were made.

[0172] The specific preparation method is as follows: add zolmitriptan, glycine, pullulan, acesulfame potassium, and peppermint essence into the fully dissolved xanthan gum solution, and mix to form a homogeneous solution; the following preparation method is the same as Example 1.

Embodiment 3

[0174] The preparation formula of the present invention is made up of following components:

[0175] Zolmitriptan 2.50g

[0176] Glycine 3.20g

[0177] Mannitol 3.80g

[0178] Sodium alginate 7.00g

[0179] Konjac gum 0.36g

[0180] Sucralose 0.16g

[0181] Mint essence 0.20g

[0182] Purified water 182.78g

[0183] A total of 1000 pieces were made.

[0184] The specific preparation method is as follows: Zolmitriptan, glycine, mannitol, sodium alginate, sucralose, and peppermint flavor are added to the fully dissolved konjac gum solution, and mixed to form a uniform solution; the following preparation Method is with embodiment 1.

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Abstract

An orally disintegrating tablet of 5-HT receptor agonist and a preparation method thereof are disclosed. The invention relates to an orally disintegrating tablet of 5-HT receptor agonist as well as a prescription and a process for preparing the orally disintegrating tablet of 5-HT receptor agonist by a freeze-drying method. The orally disintegrating tablet of 5-HT receptor agonist disclosed by the invention is prepared from main medicines and pharmaceutical excipients, without the need of water while administration, capable of being rapidly disintegrated in mouth, and suitable for the administration of patients with difficulty in swallowing, such as the old and children; simultaneously, the orally disintegrating tablet of 5-HT receptor agonist is suitable for administration in a condition that water is not easy to obtain during travelling; and the orally disintegrating tablet of 5-HT receptor agonist has the advantages of being convenient to take, fast in absorption, small in first pass effect, small in irritation on digestive tract mucosa and the like, as well as has wide market application prospect. Moreover, the orally disintegrating tablet of 5-HT receptor agonist disclosed by the invention can obviously reduce the side effects of 5-HT receptor agonist. Additionally, the invention further relates to a preparation method for the orally disintegrating tablet of 5-HT receptor agonist.

Description

Technical field: [0001] The invention relates to a 5-HT receptor agonist orally disintegrating tablet and a preparation method thereof, in particular to a 5-HT receptor agonist orally disintegrating tablet prepared by a freeze-drying method. Background technique: [0002] Migraine is a common primary angioneural headache characterized by moderate to severe throbbing headache lasting 4-72 hours, mostly hemilateral, often accompanied by nausea, vomiting, phonophobia and photophobia Wait, with or without aura. Migraine begins in children, mainly adults aged 25 to 55 who are at their peak working capacity. Epidemiological surveys show that the incidence of migraine in western countries is 10%, and most patients are women; in my country, the incidence is 4.2% to 14.6%, and the ratio of male to female is 1:4, of which 85% are female and 82% are male. The above patients lose their ability to work during the migraine attack, which significantly affects their daily activities. The ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K45/00A61K47/36A61K31/422A61P25/06
Inventor 王丛威王洪飞赵淑欣王丽滨周立运
Owner BEIJING QUANTUM HI TECH PHARMA TECHCO
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