Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

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
View PDF2 Cites 5 Cited by
  • 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 tablets have great clinical advantages. Therefore, it is necessary to find out a kind of ebastine dispersible tablets and its preparation method.

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0021] The preparation method of the ebastine dispersible tablet according to the present invention, the method is: first disperse the ebastine in the binder solution whose temperature is 86-100 DEG C by hot melt in proportion, and the dispersion time is 5-20 Minutes; then mix the filler, disintegrant and the above-mentioned hot-melt adhesive together and then granulate, pass through 30-45 mesh wet granulation, dry at 45-55°C for 4-6 hours, and then granulate after 35-40 mesh granulation Add disintegrating agent, corrective agent, glidant, lubricant, and after total mixing, compress into tablets to obtain ebastine dispersible tablets.

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

[0023] A preferred technical solution of the present invention is: first hot-melt disperse 10 parts of ebastine in 105 parts of binder solution at a temperature of 90-95 ° C, and the dis...

Embodiment 1

[0025] Embodiment 1: Comparing the influence of different hot-melt temperatures on the dispersion degree of ebastine hot-melt dispersion.

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

[0027] Take by weighing the mannitol of 108 parts by weight, the microcrystalline cellulose of 40 parts by weight, the cross-linked polyvinylpyrrolidone of 11 parts by weight, the cross-linked carboxymethyl cellulose sodium of 11 parts by weight, add hot-melt adhesive granulation, Pass 30 mesh to 40 mesh wet granulation, dry at 45°C to 55°C for 4-6 hours, add 5 parts by weight of cross-linked polyvinylpyrrolidone, 5 parts by weight of croscarmellose sodium, 1 weight part of stevioside, 2 weight parts of micropowdered silica gel, and 2 weight parts of magnesium stearate wer...

Embodiment 2

[0031] Embodiment 2: Disintegrant selection experiment.

[0032] Add 66.7% disintegrant (process A) when granulating, add the whole amount of disintegrant (process B) when granulating, and add no disintegrant (process C) when granulating, and compare the content of the final tablet with uniformity Spend.

[0033] Table 2: Content uniformity of ebastine dispersible tablets with different disintegrants added

[0034] craft

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

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

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
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
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com