Ebastine dispersible tablet and preparation method thereof

A technology of ebastine and ebastine fever, which is applied in the direction of medical preparations of non-active ingredients, pharmaceutical formulas, active ingredients of heterocyclic compounds, etc., to avoid excessive drug concentration, high bioavailability, and easy to take convenient effect

Active Publication Date: 2013-06-05
杭州仟源保灵药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, only ebastine ordinary tablets are on the market in China. For patients with swallowing inconvenience, ebastine dispersible t

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0021] The method for preparing ebastine dispersible tablets of the present invention is as follows: firstly, ebastine is hot-melt-dispersed in an adhesive solution at a temperature of 86-100°C in proportion, and the dispersion time is 5-20 Minutes; then mix the filler, disintegrant and the hot melt adhesive together and then granulate. After 30-45 mesh wet granulation, drying at 45-55℃ for 4-6 hours, 35-40 mesh granulation Add disintegrant, corrective agent, glidant and lubricant, and then press the tablet to prepare ebastine dispersible tablet.

[0022] 60-70% of the disintegrant is used in the preliminary granulation process, and the remaining 30-40% is used in the final mixing process after granulation.

[0023] A preferred technical solution of the present invention is: first disperse 10 parts of ebastine in 105 parts of adhesive solution at a temperature of 90-95°C by hot melt, and the dispersion time is 10-15 minutes; and then 148 fillers , 35 parts of 66.7% disintegrant an...

Example Embodiment

[0025] Example 1: Comparison of the influence of different hot melt temperatures on the dispersion of ebastine hot melt dispersion.

[0026] Weigh 5 parts by weight of hypromellose into 100 parts by weight of water, stir until it is clear and transparent, heat to different temperatures, weigh 10 parts by weight of ebastine and add it to it to melt and disperse, the dispersion time is 10 minutes.

[0027] Weigh 108 parts by weight of mannitol, 40 parts by weight of microcrystalline cellulose, 11 parts by weight of cross-linked polyvinylpyrrolidone, and 11 parts by weight of cross-linked sodium carboxymethyl cellulose, add hot melt adhesive to granulate, Wet sizing through 30 to 40 mesh, drying at 45°C to 55°C for 4-6 hours, adding 5 parts by weight of cross-linked polyvinylpyrrolidone, 5 parts by weight of croscarmellose sodium, 1 part by weight of stevioside, 2 parts by weight of finely powdered silica gel, and 2 parts by weight of magnesium stearate were mixed for 20 minutes, and...

Example Embodiment

[0031] Example 2: Disintegrant selection experiment.

[0032] 66.7% disintegrant was added during granulation (process A), the entire amount of disintegrant was added during granulation (process B), no disintegrant was added during granulation (process C), and the final tablet content was uniform. degree.

[0033] Table 2: Content uniformity of process Ebastine dispersible tablets with different disintegrants

[0034] Craft

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PUM

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Abstract

An ebastine dispersible tablet comprises the following components: ebastine, disintegrating agent, filling agent, corrigent, glidant, lubricant and adhesive solution. The ebastine is dispersed in the adhesive solution in a hot-melt mode. The adhesive solution is taken as a carrier to form a hot-melt solid-liquid dispersoid. The ebastine dispersible tablet is obtained by tabletting the hot-melt solid-liquid dispersoid together with the disintegrating agent and the filling agent after wet granulation, drying and total mixing. A preparation method of the ebastine dispersible tablet includes the steps of proportionally dispersing the ebastine in the adhesive solution of 86-100DEG C in a hot-melt mode, wherein the dispersing time period is 5 to 20 minutes; mixing the filling agent, the disintegrating agent and the hot-melt adhesive together to pelletize; adding the disintegrating agent, the corrigent, the glidant and the lubricant after 30-45 meshes of wet granulation, 4-6 hours of drying at 45-55 DEG C and 35-40 meshes of granulation; and obtaining the ebastine dispersible tablet after total mixing and tabletting. The ebastine dispersible tablet is rapid in dissolution, high in dissolution rate, non-toxic, high in safety, capable of being rapidly disintegrated and dispersed, and good in flavor and taste.

Description

technical field [0001] The invention relates to an ebastine dispersible tablet and a preparation method thereof, belonging to the technical field of medicine and preparation. Background technique [0002] Ebastine is a new type of anti-allergic drug developed by Almirall in Spain. It is a new type of long-acting, non-sedating second-generation histamine H1 receptor antagonist of the new cloperidine class. It has been marketed in more than 50 countries. Compared with first-generation H1 antihistamines, second-generation H1 antihistamines have relatively fewer adverse reactions. The incidence of adverse events caused by overdose is low. The first-generation antihistamines have side effects such as sedation and anticholinergic due to their poor specificity, but they still occupy a certain proportion; the second-generation antihistamines are difficult to penetrate the blood-brain barrier. There are few adverse reactions such as dryness and blurred vision, and the second-genera...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/445A61K47/38A61K47/32A61P37/08
Inventor 虞英民赵源徐承智沈文忠楼聪胡晓岚楼晓燕朱金梁汤丽倩
Owner 杭州仟源保灵药业有限公司
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