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Oral disintegrant tablet and its preparation method

A technology of orally disintegrating tablets and disintegrants, which can be used in pharmaceutical formulations, medical preparations of non-active ingredients, and pill delivery, and can solve the problems of long disintegration time, high cost, and large investment in equipment

Inactive Publication Date: 2004-02-25
北京中西经纬释药技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The earliest development of freeze-drying method is a very mature technology in foreign countries, but this method requires large equipment investment, long production cycle, low tablet strength, special requirements for packaging, small drug loading, and high cost
Its biggest advantage is that it disintegrates very quickly and disintegrates within 10 seconds in the oral cavity. There are a variety of patented technologies for tablet compression, such as flash release drug delivery technology (FlashDose), microencapsulated drug technology (Orasolv), wet method Tablet compression technology, direct compression technology, etc. Some of these methods require special equipment and special packaging equipment and technology, and some have simple processes that do not require special equipment and technology, but the disintegration time is longer, generally 30 seconds, or the taste is not good. it is good

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment Construction

[0023] The present invention is described in detail below in conjunction with embodiment:

[0024] The orally disintegrating tablets provided by the invention include:

[0025] 1. Drug active ingredient: it can be any drug suitable for or required to be made into disintegrating tablets, such as risperidone (psychotropic drug), ribavirin (antiviral drug), roxithromycin (anti-infective drug) drugs), etc. The minimum specification of the active ingredient of the above-mentioned medicine is 2 mg, and the maximum is 100 mg. When it is difficult to obtain a better effect by adding flavoring agents, the powder of the active ingredient of the drug can be taste-masked and coated. After coating, the active ingredient of the drug will increase in weight by 2 times, and the particle size after coating should be below 200 μm to reduce oral cavity The gritty feeling.

[0026] 2. Diluent: use mannitol and lactose. Mannitol dissolves and absorbs heat, and there is a cool feeling in the mo...

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PUM

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Abstract

The present invention relates to an oral disintegration tablet and its preparation method. It includes the medicinal active component and auxiliary material. Auxiliary material includes diluting agent and disintegrant, in which the diluting agent is mannite and lactose and the disintegrant is microcrystal cellulose, low-substituted hydroxypropyl cellulose and cross-linked polyvinylpyrrolidone, the weight of disintegrant is less than 25% of total weight of the auxiliary material, the weight ratio of medicinal active component and auxiliary material is 1:2-75. Said disintegration tablet has enough hardness (strength).

Description

technical field [0001] The invention relates to a new drug dosage form, in particular to an orally disintegrating tablet and a preparation method thereof. The orally disintegrating tablet preparation disintegrates rapidly by saliva without taking water or chewing in the oral cavity. Background technique [0002] Develop a new dosage form that disintegrates the tablet quickly by saliva in the mouth without taking water, and enters the stomach with the action of swallowing. very necessary. [0003] At the end of the 1970s, a high-porosity oral freeze-dried preparation was prepared by the British Weyth company (Weyth) using freeze-drying technology. It developed rapidly in the 1990s. At present, dozens of drugs have been made into this dosage form and sold abroad. , [0004] From the perspective of preparation technology of orally disintegrating tablets, it can be divided into two categories, namely freeze-drying method and tableting method. The freeze-drying method was the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/38
Inventor 王朝权门旦旦刘眉
Owner 北京中西经纬释药技术有限公司
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