Fexofenadine hydrochloride orally disintegrating tablet and preparation method thereof

Abstract

The invention discloses a fexofenadine hydrochloride orally disintegrating tablet, which consists of fexofenadine hydrochloride, a composite disintegrating agent, a filling agent, a lubricating agent and a composite flavoring agent. The fexofenadine hydrochloride orally disintegrating tablet is characterized in that the composite disintegrating agent is a highly efficient disintegrating agent, the highly efficient disintegrating agent is added internally and externally; and the composite flavoring agent is also added internally and externally. The orally disintegrating tablet of the inventionhas more excellent quality, can completely disintegrate in the oral cavity within 30 seconds, and has no gravel sense and no bitterness, and the dissolution can be more than 80 percent when determining the dissolution with water as the medium for ten minutes.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a fexofenadine hydrochloride orally disintegrating tablet. [0002] The "high-efficiency disintegrant" in the present invention refers to an excipient added to the tablet to overcome the binder or the physical force required for tablet compression, and to promote the rapid disintegration of the tablet into small particles. [0003] The "internal addition method" in the present invention refers to the addition of pharmaceutical excipients before granulation during preparation. [0004] The "external addition method" in the present invention refers to the addition of pharmaceutical excipients to the sized dry granules during the preparation of the preparation. [0005] The "internal and external addition" in the present invention means that the pharmaceutical excipients are added according to the internal and external addition. [0006] "Composite" in the present invention refers ...

AI Technical Summary

Problems solved by technology

[0010] Chinese patent CN10113980A discloses a pharmaceutical composition of fexofenadine hydrochloride, which uses fexofenadine hydrochloride as a raw material and uses a high-efficiency disintegrant as an auxiliary material to prepare an immediate-release preparation. This patent provides a high-efficiency The disintegrating agent is a technical inspiration for the preparation of orally disintegrating tablets through internal and external addition. Although it meets the dissolution evaluation indicators specified in the Pharmacopoeia, the best fexofenadine hydrochloride oral disintegration has not been optimized according to the characteristics of orally disintegrating tablets. tablet (such as 1 minute disintegration in the oral cavity, very bitter taste, etc.), and there is no flavoring agent in the prescription, which will reduce the patient's compliance; US Patent 995975 discloses a fexofenadine orally disintegrating tablet , the patent gives the technical inspiration of using 3%-15% tablet weight disintegrant, but its evaluation index is the dissolution index of hydrochloric acid as the medium, although it can meet the requirements, but using hydrochloric acid as the dissolution medium is not compatible with Therefore, the patent does not optimize the prescription of the best oral disintegrating agent for the properties of the raw material fexofenadine hydrochloride

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