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Bilastine orally disintegrating tablet and preparing method thereof

A disintegrating tablet and prescription technology, applied in the field of bilastine orally disintegrating tablets and its preparation, can solve problems such as sensitization and toxicity

Inactive Publication Date: 2015-03-11
万全万特制药江苏有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although solubilizers have a strong solubilizing effect, such solubilizers and their metabolites are likely to cause biological changes in the body, and long-term use may cause side effects including toxicity, teratogenicity, carcinogenicity, sensitization, Safety issues such as hemolysis

Method used

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  • Bilastine orally disintegrating tablet and preparing method thereof
  • Bilastine orally disintegrating tablet and preparing method thereof
  • Bilastine orally disintegrating tablet and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034]

[0035] Preparation process: This dosage form can be produced by conventional tablet pharmaceutical equipment and prepared by direct tableting process. The specific preparation method is as follows: the main drug is ground and passed through an 80-mesh sieve, and cross-linked carboxymethylcellulose sodium (CMC-Na) is passed through a 100-mesh sieve. Sieve, microcrystalline cellulose and lactose are respectively passed through 40 mesh sieves, respectively weighed according to the amount and then added to the main drug and mixed evenly, then the prescribed amount of magnesium stearate is added, sieved and mixed evenly, and the intermediate content is detected. After determining the weight of the tablet, the tablet is compressed by direct compression technology, and the product is obtained.

Embodiment 2

[0037]

[0038] Preparation process: This dosage form can be produced by conventional tablet pharmaceutical equipment and prepared by direct compression process. The specific preparation method is as follows: the main drug is ground and passed through an 80-mesh sieve, low-substituted hydroxypropyl cellulose is passed through a 100-mesh sieve, microcrystalline cellulose and The lactose is respectively passed through a 40-mesh sieve, weighed according to the amount and added to the main drug and mixed evenly, then the prescribed amount of magnesium stearate is added, sieved and mixed evenly, and the content of the intermediate is detected. After determining the weight of the tablet, the tablet is compressed by direct compression technology, and the product is obtained.

Embodiment 3

[0040]

[0041] Preparation process: This dosage form can be produced by using conventional tablet pharmaceutical equipment and prepared by dry granulation and tabletting process. The specific preparation method is as follows: pass the main drug, lactose, microcrystalline cellulose and cross-linked polyvinylpyrrolidone through a 100-mesh sieve, Weigh and add in sequence according to the amount, sieve and mix evenly, press into tablets, pass through a 18-mesh sieve for dry granulation. Then add the magnesium stearate of prescription quantity, sieve and mix, carry out intermediate content detection. After determining the weight of the tablet, it can be obtained by pressing the tablet.

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Abstract

The invention belongs to the technical field of medicines, and relates to a bilastine orally disintegrating tablet and a preparing method of the bilastine orally disintegrating tablet. The bilastine orally disintegrating tablet comprises, by weight, 15%-30% of bilastine, 35%-74% of microcrystalline celluloses, 10%-40% of lactose, 0%-10% of dry binding agents, 2.0%-10% of disintegrating agents and 0.4%-3% of lubricating agents. According to a preparation process, the direct powder compression technology and the dry granulating technology are adopted. The bilastine orally disintegrating tablet is simple in preparation process, low in cost, convenient to take and high in effect taking on adaptation diseases. After being orally taken, the bilastine orally disintegrating tablet is rapidly disintegrated and dispersed into fine particles or powder in the oral cavity, and is particularly suitable for patients difficult in swallowing and psychopaths; in addition, before reaching the gastrointestinal tract, the preparations has been generated in the mode of fine particles or powder, the medicines are dissolved in an accelerated mode; the distribution area of the medicines in the gastrointestinal tract is large; the number of absorbing points is large; and the bioavailability of the bilastine orally disintegrating tablet can be improved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to bilastine orally disintegrating tablets and a preparation method thereof. Bilastine is used as an active ingredient in an oral solid dosage form for the treatment of allergic rhinoconjunctivitis (seasonal and perennial) and urticaria. Background technique [0002] Bilastine (4-[2-[4-(2-ethoxyethyl)-1H-benzimidazol-2-yl]-1-piperidinyl]ethyl]-α,α-dimethyl Phenylacetic acid) is the second-generation histamine H1-receptor antagonist developed by Spanish FAES Pharmaceutical Company, which is used for the treatment of allergic rhinoconjunctivitis (seasonal and perennial) and urticaria. Studies in healthy subjects and patients with rhinitis have shown that this product is safe, without the sedative effect and cardiotoxicity of commonly used antihistamines. The description of bilastine for treating allergic rhinoconjunctivitis and urticaria diseases is mentioned i...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/454A61K47/38A61K47/26A61P37/08A61P11/02A61P17/00
Inventor 鲍晶晶刁媛媛马苏峰
Owner 万全万特制药江苏有限公司
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