Orally disintegrated galantamine hydrobromide tablet and its prepn process

A technology of galantamine hydrobromide and hydrobromic acid is applied in the directions of pill delivery, nervous system diseases, active ingredients of heterocyclic compounds, etc., and can solve the problems of adverse effects of disease treatment, difficult swallowing of drugs, inconvenient use, and the like, Achieving stable blood drug concentration levels, improving compliance, and easy control

Inactive Publication Date: 2007-03-21
耿燕
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0007] Since the treatment of senile dementia requires long-term medication, and most of the drug users are elderly people, the oral preparations of galantamine hydrobromide currently on the market are all conventional preparations, such as tablets and capsules, which are difficult for the elderly who have difficulty swallowing. It is very inconvenient for children to use, and often elderly patients or children are unwilling to take these conventional solid preparations, and complain that the medicine is difficult to swallow or blocks the esophagus
At the same time, drinking water is also required when taking the above-mentioned conventional oral preparations, and it is very inconvenient to use the medicine in many situations where water is scarce or inconvenient to drink, thus bringing adverse effects to the treatment of diseases.

Method used

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  • Orally disintegrated galantamine hydrobromide tablet and its prepn process
  • Orally disintegrated galantamine hydrobromide tablet and its prepn process

Examples

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example 1

[0050] Example 1: An orally disintegrating tablet of immediate-release galantamine hydrobromide and its preparation method

[0051] The orally disintegrating tablet of galantamine hydrobromide is composed of main drug and auxiliary materials, and the ratio is: main drug 8.5%, auxiliary materials 91.5%. The proportion of each component is as follows:

[0052] Galantamine Hydrobromide 5.5g

[0053] Microcrystalline Cellulose 45.0g

[0054] Low-substituted hydroxypropyl cellulose 5.0g

[0055] Cross-linked polyvinylpyrrolidone 4.5g

[0056] Micronized silica gel 2.0g

[0057] Magnesium Stearate 2.0g

[0058] Stevioside 1.0g

[0059] Sweet orange solid essence 0.01g

[0060] A total of 1000 pieces were made

[0061] The preparation method of the galantamine hydrobromide disintegrating tablet of this example is as follows: sieve the galantamine hydrobromide and each auxiliary material through 80 sieves, and set aside. Weigh galanthamine hydrobromide and auxiliary materials a...

example 2

[0066] Example 2: A slow-release galantamine hydrobromide orally disintegrating tablet and its preparation method

[0067] Suspend 9 g of 200 mesh sulfonic acid cation exchange resin (Amberlite IRP 64, Rohm&Hass Company) in 150 ml of purified water, add 5.0 g of galantamine hydrobromide, heat and stir at 60°C for 4 hours, filter, and dry at 80°C to obtain Galantamine hydrobromide-sulfonic acid type cation exchange resin drug adsorbate. The drug adsorbate was added to 150ml of 0.5% ethylcellulose cyclohexane solution, heated and stirred, refluxed for 1 hour, cooled to 10°C, filtered, and dried at 60°C for 12 hours to obtain the coated drug adsorbate.

[0068] Sustained-release galantamine hydrobromide orally disintegrating tablets were prepared according to the following formula:

[0069] Coated drug adsorbate 14.75g

[0070] Mannitol 25.0g

[0071] Microcrystalline Cellulose 20.0g

[0072] Cross-linked polyvinylpyrrolidone 4.0g

[0073] Low-substituted hydroxypropyl cellu...

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Abstract

The present invention discloses one kind of quickly releasing orally disintegrated galantamine hydrobromide tablet and one kind of slowly releasing orally disintegrated galantamine hydrobromide tablet and their preparation process. The quickly releasing orally disintegrated galantamine hydrobromide tablet is prepared with galantamine hydrobromide, filler, disintegrant, lubricant, etc and through mixing and direct tabletting. The slowly releasing orally disintegrated galantamine hydrobromide tablet is prepared through adsorbing galantamine hydrobromide with powdered sulfonic acid type ion resin via ion exchange, coating with coating agent, mixing with filler, disintegrant, lubricant, etc and final direct tabletting. The orally disintegrated galantamine hydrobromide tablets of the present invention have fast disintegration, good taste and raised patient's compliance.

Description

1. Technical field [0001] The invention relates to a medicine and a preparation method thereof, in particular to an orally disintegrating tablet of quick-release and sustained-release galanthamine hydrobromide and a preparation method thereof. 2. Background technology [0002] Alzheimer's disease (AD), commonly known as senile dementia, is a common progressive neurodegenerative disorder in the elderly, and its clinical manifestations are mainly memory loss and cognitive dysfunction. Alzheimer's disease seriously affects the life of tens of thousands of elderly people and their family members, and also adds a heavy burden to the society. In recent years, it has attracted widespread attention from the international community. With the aging of the social population, the incidence of senile dementia is relatively increasing. Currently, the prevalence of dementia over the age of 65 is 5% to 10%, and it is still increasing. Alzheimer's disease ranks third in medical costs in the...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/55A61P25/28
Inventor 王宗贵耿燕孙宏张
Owner 耿燕
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