Bilastine tablet and preparation method thereof

Abstract

The invention belongs to the technical field of medicinal preparations, and particularly relates to a bilastine tablet capable of realizing direct powder compression adopting silicified microcrystalline cellulose, and a preparation method thereof. The tablet is prepared from the following components by weight percent: 1 to 10 percent of bilastine, 10 to 90 percent of silicified microcrystalline cellulose, 3 to 20 percent of a disintegrating agent, 0.5 to 5 percent of a lubricating agent, and 0 to 5 percent of a flow aid. According to the bilastine tablet and the preparation method thereof provided by the invention, the defects of poor fluidity and compressibility of the bilastine are overcome, a recipe and a technology of direct bilastine compression are realized, the preparation technology is simpler, the stability of the product quality is ensured, and the method is suitable for mass production.

Description

technical field [0001] The application belongs to the technical field of pharmaceutical preparations, and in particular relates to a bilastine tablet which adopts silicified microcrystalline cellulose powder and can be directly compressed into tablets and a preparation method thereof. Background technique [0002] Bilastine 4-[2-[4-(2-ethoxyethyl)-1H-benzimidazol-2-yl]-1-piperidinyl]ethyl]-α,α-dimethyl Phenylacetic acid is a second-generation histamine H1 receptor antagonist developed by Spanish FAES Pharmaceutical Company for the treatment of allergic rhinoconjunctivitis (seasonal and perennial) and urticaria diseases. [0003] Prior art CN201410591282.7 discloses an orally disintegrating tablet containing bilastine and its preparation method, wherein the preparation process can adopt dry granulation and powder direct compression technology, but in actual production it is found that bilastine Poor fluidity and compressibility can pose higher technical challenges to quality...

AI Technical Summary

Problems solved by technology

[0003] Prior art CN201410591282.7 discloses an orally disintegrating tablet containing bilastine and its preparation method, wherein the preparation process can adopt dry granulation and powder direct compression technology, but in actual production it is found that bilastine Poor fluidity and compressibility can pose higher technical challenges to quality standards such as direct powder compression to ensure product content uniformity. Common types of microcrystalline cellulose have low bulk density, high lubrication sensitivity, and high flowability. Poor performance and compressibility are easily affected by water content and other reasons

Cannot meet all requirements of the powder direct compression process