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Bilastine orally disintegrating tablet and preparation method thereof

A technology of disintegrating tablets and flakes, which is applied in the field of bilastine orally disintegrating tablets and its preparation, can solve the problems of large variation range between contents, black spots on the surface of tablets, and large variation range of contents, etc., to achieve potential Low risk, good durability, good taste effect

Pending Publication Date: 2021-11-19
NANJING CHANGAO PHARMA SCI & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Question 1: The original preparation has strong hygroscopicity, and the disintegration time becomes slower after long-term storage. The study of influencing factors shows that black spots will appear on the surface of the tablet when it is placed at a high temperature of 60°C
[0007] Question 2: Orally disintegrating tablets need to disintegrate in the mouth, so taste is particularly important. In the CDE research meeting, it is required that the dosage form should have no gritty feeling after disintegration. Patent CN104398481A uses a water-insoluble auxiliary material microcrystalline cellulose As the main filler, and dry granulation is adopted, the resulting granules are relatively hard, which seriously affects the taste
[0008] Question 3: Although the content uniformity of the original preparation complies with the Pharmacopoeia standard, the content varies widely. The inventor found that bilastine raw material and excipients are easily re-stratified during the transfer process after being evenly mixed, mainly in the discharge During the process and tablet vibration process, the content uniformity is poor, and the content of each tablet varies in a large range

Method used

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

Examples

Experimental program
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Effect test

Embodiment 1-6

[0060] The prescription of embodiment 1-6 is as shown in table 3:

[0061] The prescription of table 3 embodiment 1-6

[0062]

[0063]

[0064] In Table 3, the mannitol used in Example 1 is the mannitol 160C produced by Roquette, France, and the mannitol used in Example 2 is the mannitol Granutol F produced by Japan Furende Sangyo Co., Ltd., and the mannitol used in Example 3. The mannitol is the mannitol 25C that French Roquette produces, and the mannitol that embodiment 4 uses is the mannitol 50C (the mannitol particle diameter of embodiment 1-4 is shown in Table 1) that French Roquette produces, and embodiment 5 The mannitol used is the mannitol produced by Roquette, France. After crushing at 160C, the particle size is controlled to 48.86μm50 90 50 90 <134.72 μm. The pulverized mannitol was confirmed to be in the form of flakes through a microscope.

[0065] The technological process of embodiment 1-6:

[0066] (1) Weigh the prescribed amount of hypromellose and a...

Embodiment 7

[0072] Embodiment 7 quality evaluation

[0073] 1. Detection method of content uniformity: take 10 tablets of the comparative example and the embodiment tablet respectively, put 10 tablets in 10 measuring bottles respectively, add solvent to dissolve and dilute the main ingredient to make about 1 ml of Bilas The need testing solution of bilastine 0.5mg is injected into the high performance liquid chromatograph, and the chromatogram is recorded; the reference substance solution containing about 0.5mg of bilastine is prepared in the same way, and each single dose is calculated by the peak area according to the external standard method The indicated amount is 100% relative content.

[0074] 2. Moisture absorption weight gain detection method: take 10 tablets of the comparative example and the embodiment, accurately weigh its weight m1, place it under the environment of RH90%±5% for 10 days, accurately weigh its weight m2, and calculate the weight gain percentage for

[0075] ...

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Abstract

The invention discloses a bilastine orally disintegrating tablet and a preparation method thereof. The bilastine orally disintegrating tablet is mainly characterized in that the bilastine orally disintegrating tablet is composed of a bilastine raw material medicine, mannitol, croscarmellose sodium, hydroxypropyl methylcellulose and sodium stearyl fumarate, a filling agent in the prescription is flaky mannitol, and the particle size is controlled within a certain range. The bilastine orally disintegrating tablet prepared by the method is small in content uniformity potential risk, stable in process, controllable in quality and good in taste, and the bilastine orally disintegrating tablet is better in quality.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparation research, and in particular relates to a bilastine orally disintegrating tablet and a preparation method thereof. Background technique [0002] Bilastine is a histamine H1 receptor antagonist produced by FAES FARMA in Spain. The 20mg ordinary tablet was first approved in Germany on September 8, 2010 for symptomatic rhinitis (seasonal and perennial) and urticaria. The symptomatic treatment of measles was subsequently approved in the EU / EEA (28 countries including France, UK), and as of August 2020, it has been approved in 122 countries / regions including Singapore, Brazil, Mexico, and Japan. But currently there is no bilastine preparation on the market in China. [0003] The oral administration form of ordinary tablets can meet the needs of ordinary adults, but for children, the specifications are large and difficult to swallow, which affects the compliance of drug therapy. Or solid prepa...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/26A61K31/454A61P11/02A61P37/08A61P17/00
CPCA61K9/0056A61K9/2018A61K9/2095A61K31/454A61P11/02A61P37/08A61P17/00
Inventor 黄洋臧萍钟雪彬李纬张雪宜王益群
Owner NANJING CHANGAO PHARMA SCI & TECH CO LTD
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