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Desloratadine sublingual tablet and preparation method thereof

A technology of desloratadine and loratadine, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve the problem of gastric emptying time limitation of onset time and other problems , to achieve the effects of improving bioavailability, fast blood flow, and avoiding the first-pass effect

Inactive Publication Date: 2016-09-28
ZHEJIANG KAIRUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Currently, there are tablets, dispersible tablets, dry suspensions, syrups, and oral liquids available for patients on the market. After administration, the drugs are absorbed into the blood through the gastrointestinal tract to play a curative effect; the onset time is determined by gastric emptying. Time and intestinal absorption limitations

Method used

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  • Desloratadine sublingual tablet and preparation method thereof
  • Desloratadine sublingual tablet and preparation method thereof
  • Desloratadine sublingual tablet and preparation method thereof

Examples

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preparation example Construction

[0052] A method for preparing desloratadine sublingual tablets as described above, the preparation method includes:

[0053] a) Preparation of desloratadine dispersion: After desloratadine is dissolved in ethanol, it is added to the inclusion agent or inclusion agent, filler or inclusion agent, filler, disintegrant mixture to make a soft material, and Prepared by drying at a temperature of at least 50°C;

[0054] b) Mixing the obtained desloratadine dispersion with fillers or flavoring-containing fillers, disintegrants, stabilizers and other pharmaceutically acceptable carriers as auxiliary materials to prepare tablets.

[0055] In the step a) of the present invention, the preparation of desloratadine dispersion is: desloratadine is dissolved in 5-10ml ethanol and then added to sulfobutyl-β-cyclodextrin as an inclusion agent, micro The crystalline cellulose is used as a filler and croscarmellose sodium is used as a disintegrant to make a soft material in a homogeneous mixture, which...

Embodiment 1

[0067] Composition of plain tablets

[0068]

[0069] Preparation method:

[0070] (1) Preparation of desloratadine dispersion: PEG2000, microcrystalline cellulose, and croscarmellose sodium are mixed uniformly. Deloratadine is dissolved in 5-10ml of ethanol and then added to the above mixture to make a soft material, which is dried at 60°C to obtain a desloratadine dispersion.

[0071] (2) Mix the desloratadine dispersion with the above-mentioned auxiliary materials uniformly. Tablet.

Embodiment 2

[0073] Composition of plain tablets

[0074]

[0075]

[0076] Preparation method:

[0077] (1) Preparation of desloratadine dispersion: PEG4000, microcrystalline cellulose, and croscarmellose sodium are mixed uniformly. Deloratadine is dissolved in 5-10ml of ethanol and then added to the above mixture to make a soft material, which is dried at 60°C to obtain a desloratadine dispersion.

[0078] (2) Mix the desloratadine dispersion with the above-mentioned auxiliary materials uniformly. Tablet.

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Abstract

A kind of desloratadine sublingual tablet and its preparation method. It is a plain tablet or a film-coated tablet composed of a layer of film coating on the surface of the plain tablet. The plain tablet is dispersed by desloratadine. The body is used as the main material, mixed with fillers or flavoring-containing fillers, disintegrants, stabilizers and other pharmaceutically acceptable carriers as auxiliary materials and made into tablets; the desloratadine dispersion is : Desloratadine is prepared by dissolving it with ethanol and then adding it to a mixture of inclusion agent or inclusion agent, filler or inclusion agent, filler and disintegrant to make a soft material and then drying; the preparation method includes: a ) Preparation of desloratadine dispersion: Desloratadine is dissolved in ethanol and added to the mixture of inclusion agent, filler or inclusion agent, filler and disintegrant to make a soft material, and then Prepared by drying at a temperature of at least 50°C; b) Mix the obtained desloratadine dispersion with fillers or flavoring-containing fillers, disintegrants, stabilizers and other pharmaceutically acceptable carriers as excipients and press Made of slices.

Description

Technical field [0001] The invention relates to a desloratadine sublingual tablet and a preparation method thereof, and belongs to the technical field of pharmaceuticals and their preparation. Background technique [0002] Desloratadine is a non-sedating, long-acting histamine antagonist with potent and selective antagonism of peripheral H1 receptors. Desloratadine has been proven to have anti-allergic, antihistamine and anti-inflammatory effects. After oral administration, desloratadine is effectively excluded from the central nervous system (CNS), thus selectively blocking the peripheral nervous system. Amine H1 receptor. [0003] The clinically selected dosage forms of desloratadine include tablets, dispersible tablets, syrups, oral solutions, etc. A large number of research literature reports show that desloratadine has strong anti-allergic effects and is widely used in clinical applications, including chronic idiopathic urticaria, perennial allergic rhinitis and other...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/40A61K47/38A61K47/10A61K31/4545A61P37/08
CPCA61K9/006A61K9/2054A61K9/2059A61K31/4545
Inventor 莫荣喜沈阳邱兵
Owner ZHEJIANG KAIRUN PHARMA
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