Imidafenacin film-coated tablet and preparation method thereof

Abstract

The invention provides an imidafenacin film-coated tablet. The imidafenacin film-coated tablet comprises raw and auxiliary materials in parts by weight as follows: 1-5 parts of imidafenacin, 700-850 parts of pregelatinized starch, 600-700 parts of microcrystalline cellulose, 3-6 parts of lubricants and appropriate coating agents. The invention further provides a preparation method of the film-coated tablet. According to research findings, the imidafenacin can dissolve completely even in 5min in a specific prescription ratio of the tablet; meanwhile, a specific fluidized bed granulation process is adopted, so that the uniformity of the content of the imidafenacin in the preparation can be remarkably improved; and the content of main drugs in the imidafenacin tablet is quite low, so that the quality uniformity of drugs is well guaranteed with the preparation method.

Description

technical field [0001] The invention relates to a midanacin film sheet and a preparation method thereof. Background technique [0002] Overactive Bladder (OAB) is a symptom syndrome that presents symptoms of urinary incontinence, frequent urination, and a sense of urgency to urinate. People with overactive bladder experience frequent urination and urinary incontinence due to involuntary contractions of the bladder (overactive bladder muscle). In overactive bladder, involuntary contractions may be caused by neuropathology and other cases, the former being called neuropathic bladder dysfunction and the latter being called unstable bladder disorder. At present, there are seven kinds of antimuscarinic drugs used in the treatment of OAB in the world, oxybutynin, tolterodine, propiverine, trospamine, darfinacin, solifenacin, etc. [0003] Midanacin is a bladder-selective anticholinergic compound with a butane imidazolamide skeleton structure, which has dual effects of inhibiting...

AI Technical Summary

Problems solved by technology

In terms of industrial production, the preparation process of mixing granulation with the binder containing the main drug of midanacin and the auxiliary materials is currently mainly used, but this process has a high risk of poor product content uniformity; in view of the above situation, the researchers The above-mentioned problems are mainly solved by means of micronization of raw materials or introduction of solubilizers. The effect of the former is not ideal in the transformation into industrial production, and the safety of the latter needs further investigation.

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