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Oral disintegrating tablet and preparation method thereof

An orally disintegrating tablet and technology of disintegrating tablet, which are applied in the field of oral disintegrating tablet containing two components as binder and its preparation field

Inactive Publication Date: 2012-08-01
QUANTUM HI TECH BEIJING RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In order to solve the above-mentioned technical problems, the inventor of the present invention, after long-term research and experimental exploration, through a large number of experiments, found that gelatin and pullulan can make up for their respective deficiencies

Method used

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  • Oral disintegrating tablet and preparation method thereof
  • Oral disintegrating tablet and preparation method thereof
  • Oral disintegrating tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Prepare orally disintegrating tablets according to the prescription in the table below.

[0050]

[0051] Accurately weigh quantitative ibuprofen, glycine, gelatin, pullulan, sucralose, and peppermint essence according to the prescription given in the above table, add them to the fully dissolved xanthan gum aqueous solution, and mix them in a homogeneous emulsifier to form a uniform Solution, that is, matrix solution; after degassing the homogeneous matrix solution prepared in the above steps under vacuum conditions, inject it into the mold accurately according to the specification of injection volume of 0.4ml; After freezing for 1 to 60 minutes under the condition of 0.01 mbar to 10 mbar and freeze drying for 1 to 10 hours under the conditions of 0.01 mbar to 10 mbar and -30°C to 30°C, the ibuprofen orally disintegrating tablet of the present invention can be obtained. . According to actual needs, the injection volume can be 0.1ml~2.0ml. Under the same ratio of eac...

Embodiment 2

[0054] Prepare orally disintegrating tablets according to the prescription in the table below.

[0055]

[0056]

[0057]The preparation method is the same as in Example 1.

Embodiment 3

[0059] Prepare orally disintegrating tablets according to the prescription in the table below.

[0060]

[0061] The preparation method is the same as in Example 1.

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Abstract

The invention discloses an oral disintegrating tablet and a preparation method thereof, and especially discloses an oral disintegrating tablet containing a bicomponent as a binder, and a preparation method thereof. The oral disintegrating tablet of the invention is prepared through adopting a lyophilizing process, and components of the tablet comprise effective doses of drug active components, a skeleton supporting agent, the binder, and a suspending aid, wherein the binder comprises pullulan and an auxiliary binder. The preparation method which utilizes the compound use of pullulan and the auxiliary binder in a specific application amount range solves problems of slow disintegration and incomplete dissolving-out when the lyophilized oral disintegrating tablet loads a large dose of the drug. Compared with lyophilized oral disintegrating tablets which are prepared with the prior art and have large drug loading doses, the lyophilized oral disintegrating tablet prepared in the invention, which has the advantages of rapid disintegration and complete dissolving-out, has a very good application value.

Description

technical field [0001] The invention relates to an orally disintegrating tablet and a preparation method thereof, in particular to an orally disintegrating tablet containing two components as a binder and a preparation method thereof. Background technique [0002] Orally disintegrating tablets, or orally dissolving tablets, refer to preparations that can rapidly disintegrate or dissolve in the oral cavity. Such preparations can quickly disintegrate and mostly dissolve when encountering saliva in the oral cavity, and can be taken without water. Orally disintegrating preparations appeared in the late 1970s. Gregory et al. used freeze-drying technology to manufacture a high-porosity pharmaceutical dosage form, which disintegrated after encountering saliva in the oral cavity. Orally disintegrating preparations are mainly suitable for the following situations: young children, the elderly, patients who are difficult to change in bed position and lack of water; patients with dyspha...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/36A61K47/42A61K8/73A61K8/02A61K8/81A61J3/00A23L1/05A23L29/20
Inventor 王丛威王洪飞刘荣周立运
Owner QUANTUM HI TECH BEIJING RES INST
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