Imidafenacin tablet and preparation method thereof

Abstract

The invention discloses an imidafenacin tablet which is prepared from the components including imidafenacin, water-soluble polymer, a filling agent, a disintegrating agent and lubricant; the water-soluble polymer is selected from one or more of poloxamer, polyethyleneglycol, hydroxypropyl methylcellulose, polyvinyl alcohol and copovidone and accounts for 0.1 percent to 3 percent (w / w) of the total weight of the whole tablet; and the disintegrating agent is pregelatinized starch or a mixture of common starch and pregelatinized starch and accounts for 15 percent to 50 percent (w / w) of the total weight of the whole tablet. The tablet provided by the invention can be dissolved in a water-based medium at an unexpected high level in relative time and has a very good dissolution characteristic and remarkable physical stability.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a midanacin tablet and a preparation method thereof, in particular to a midanacin tablet prepared by solid dispersion technology and a process thereof. Background technique [0002] Imidafenacin has a diphenylbutanamide structure and is a new type of high-efficiency anticholinergic drug. It selectively acts on M3 and M1 receptors, blocks the contraction of choline on detrusor muscle, and makes detrusor muscle Relax and reduce the side effects of drugs. At the same time, midanacin has dual effects of inhibiting the contraction of bladder smooth muscle and inhibiting the release of acetylcholine, and its selectivity to bladder is stronger than that of salivary glands, but its affinity to alkali receptors in brain tissue is low, so the central and peripheral side effects are less, and it has a high degree of Bladder selective, suitable for the treatm...

AI Technical Summary

Problems solved by technology

However, this Midanaxin tablet adopts fluidized bed spray granulation, and Midanaxin and fillers such as starch are prepared into granules, and then the water-soluble polymer is sprayed and coated on the outside of the granules, and then pressed It is said that a tablet with a certain light-shielding effect has been obtained, but after the granules obtained by this method are compressed into tablets, the water-soluble film coating wrapped will deform and rupture under the action of pressure, and the weight of the tablet of the patented preparation is too large , the production process is complex and infeasible, which increases a lot of production cost and low efficiency

[0007] CN102579393A discloses a solid pharmaceutical composition containing midanacin, which is micronized with hydrophilic adjuvant and midanacin, and the particle size of the obtained material is required to be less than 5 microns. However, the operation method of this patent is more efficient in industrial production. Low and reproducible particle size of micronized materials needs to be investigated

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