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

Bilastine composition and novel preparation process thereof

A technology of bilastine and bilastine tablets, which is applied in the field of pharmaceutical preparations, can solve problems affecting product quality, loose tablets and splits, and difficult to reach, and achieve the effects of improving sticking phenomenon, improving requirements, and stabilizing quality

Active Publication Date: 2021-03-30
CHONGQING HUAPONT PHARMA
View PDF4 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, bilastine tablets are compressed by the direct compression process, but existing studies have found that the preparation process of this product is particularly affected by the humidity of the environment, and sticking phenomenon will occur during the compression process of the direct compression process. thereby affecting product quality
Therefore, if the direct compression process is used for tableting, the environmental humidity must be strictly controlled, and the lower the humidity, the less the impact, which puts extremely high requirements on the production or test environment, including production equipment and instruments, and sometimes it is difficult to achieve
In addition, the prepared bilastine tablets are also easier to absorb moisture, and the longer the time, the more obvious the moisture absorption, which may cause loose tablets and cracks.

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

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Bilastine composition and novel preparation process thereof
  • Bilastine composition and novel preparation process thereof
  • Bilastine composition and novel preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] 1. Preparation prescription

[0030]

[0031] 2. Preparation process

[0032] 1) After mixing bilastine, 62.5 parts of lactose, microcrystalline cellulose and croscarmellose sodium in the formula quantity, pass through a 60-mesh sieve, and dissolve povidone in water to prepare a solution; (environment Humidity: 55%±10%)

[0033] 2) Fluidized bed granulation parameters are: material temperature: 35-55°C; air inlet temperature: 40-90°C; air volume: 7-35m 3 / h, the spray speed of the adhesive is 1-5rpm, and it starts to dry after the adhesive solution is sprayed;

[0034] 3) Fluidized bed drying parameters are: material temperature: 30-60°C; air inlet temperature: 35-95°C; air volume: 5-40m 3 / h, when the temperature of the material reaches 60°C, the material is discharged;

[0035] 4) granulate the dried particles through a 40-mesh sieve;

[0036] 5) Add colloidal silicon dioxide and remaining lactose to the sized granules, and mix evenly; add magnesium stearate, ...

Embodiment 2

[0038] 1. Preparation prescription

[0039]

[0040] 2. Preparation process

[0041] 1) After mixing the amount of bilastine, 35 parts of lactose, microcrystalline cellulose and croscarmellose sodium, pass through an 80-mesh sieve, and dissolve povidone in water to prepare a solution; (environmental humidity : 55%±10%)

[0042] 2) Fluidized bed granulation parameters are: material temperature: 35-55°C; air inlet temperature: 40-95°C; air volume: 7-35m 3 / h, the spray speed of the adhesive is 1-5rpm, and it starts to dry after the adhesive solution is sprayed;

[0043] 3) Fluidized bed drying parameters are: material temperature: 30-60°C; inlet air temperature: 35-95°C; air volume: 5-42m 3 / h, when the temperature of the material reaches 60°C, the material is discharged;

[0044] 4) granulate the dried particles through a 40-mesh sieve;

[0045] 5) Add colloidal silicon dioxide and remaining lactose to the sized granules, and mix evenly; add magnesium stearate, mix for ...

Embodiment 3

[0047] 1. Preparation prescription

[0048]

[0049]

[0050] 2. Preparation process

[0051] 1) After mixing the formula amount of bilastine, 30 parts of lactose, microcrystalline cellulose and croscarmellose sodium, pass through a 100-mesh sieve, and dissolve povidone in water to prepare a solution; (environmental humidity : 55%±10%)

[0052] 2) Fluidized bed granulation parameters are: material temperature: 35-55°C; air inlet temperature: 40-95°C; air volume: 7-35m 3 / h, the spraying speed of the adhesive is 1-4rpm, and it starts to dry after the adhesive solution is sprayed;

[0053] 3) Fluidized bed drying parameters are: material temperature: 30-60°C; inlet air temperature: 35-95°C; air volume: 5-45m 3 / h, when the temperature of the material reaches 60°C, the material is discharged;

[0054] 4) the dried particles are sized through a 24-mesh sieve;

[0055] 5) Add colloidal silicon dioxide and remaining lactose to the sized granules, and mix evenly; add magnes...

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

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a bilastine composition, a novel preparation process thereof and a prepared bilastine tablet, in particular to a method for reducing moisture absorption and sticking phenomena of the bilastine tablet and preventing the bilastine tablet from loosening and cracking. The composition is prepared from the following components in parts by weight: 20 parts of bilastine, 52-82.5 parts of lactose, 22.5-38 parts of microcrystalline cellulose, 2.5-6.0 parts of povidone, 1.5-5.0 parts of croscarmellosesodium, 0.5-3.0 parts of colloidal silicon dioxide and 0.5-3.0 parts of magnesium stearate. The new preparation process of the bilastine composition adopts fluidized bed granulation and drying. According to the bilastine composition and the fluidized bed granulation method, the requirement of the bilastine composition for the production environment is remarkably improved, and then the productioncost can be reduced; and the moisture absorption phenomenon of the bilastine tablet is obviously improved, and the sticking phenomenon in the tabletting process can be obviously improved, so that thebilastine tablet with stable quality is prepared.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a bilastine composition, a new preparation process thereof, and prepared bilastine tablets, a method for reducing the moisture absorption and stickiness of bilastine tablets, and making bilastine Sting tablets are not easy to loose and split the method. Background technique [0002] Bilastine, the chemical name is 2-[4-[2-[4-[1-(2-ethoxyethyl)benzodiimazol-2-yl]-1-yl]ethyl]benzene Base]-2-dimethylacetic acid is a non-sedating long-acting antihistamine developed by Spanish FAES FARMA company, which can selectively antagonize peripheral H1 receptors, has no affinity for muscarinic receptors, and has no affinity for other Receptor affinity is low. For the treatment of urticaria and seasonal allergic rhinoconjunctivitis in adolescents over 12 years of age and adults. [0003] At present, bilastine tablets are compressed by the direct compression pro...

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): A61K9/20A61K47/32A61K47/38A61K31/454A61P11/02A61P17/00A61P37/08
CPCA61K9/2095A61K9/2054A61K9/2027A61K31/454A61P11/02A61P17/00A61P37/08Y02A50/30
Inventor 胡敏陈博程刚
Owner CHONGQING HUAPONT PHARMA
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