Tablet containing imidafenacin and preparation method thereof

A midanacin and tablet technology, which is applied in the field of midanacin tablets and their preparation, can solve the problems of complex operation, low dosage, high material property requirements, etc. Actionable effect

Active Publication Date: 2018-03-06
NANJING HEALTHNICE MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The process is complicated to operate, and the selection of auxiliary materials, especially non-volatile solvents, is very limited, and the dosage must be very low, so there are many operating limitations
[0007] Chinese patent CN106580899A discloses a method for preparing midanacin tablets. Take midanacin and a cosolvent, disperse and dissolve them in absolute ethanol, then spray them on auxiliary materials, add a lubricant, and directly compress them into tablets after mixing. The process is not very mature, and has high requirements on the properties of materials

Method used

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  • Tablet containing imidafenacin and preparation method thereof
  • Tablet containing imidafenacin and preparation method thereof
  • Tablet containing imidafenacin and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Tablet formulation (10000 formulation units):

[0040]

[0041] Preparation Process:

[0042] 1. Pretreatment

[0043] 1.1 Ingredients: Weigh pregelatinized starch and microcrystalline cellulose according to the formula, pass through 80-mesh sieve respectively, and set aside.

[0044] 1.2 Preparation of adhesive solution: Add the formula amount of midanacin to 480g of 95% ethanol, stir to dissolve, slowly add 42g of povidone K30 to disperse evenly, stir to dissolve, add 600g of purified water to stir evenly, set aside.

[0045] 2. Granulation, drying, granulation

[0046] 2.1 Mix microcrystalline cellulose and pregelatinized starch, slowly add midanacin povidone K30 ethanol aqueous solution to make soft material, and granulate with 20 mesh.

[0047] 2.2 Place the wet granules in a decompression drying oven, dry at 50°C until the moisture content of the granules is not higher than 5%, and granulate with 20 mesh.

[0048] 3. Total mix

[0049] Get the granule and mi...

Embodiment 2

[0056] Tablet formulation (10000 formulation units):

[0057]

[0058] Preparation Process:

[0059] 1. Pretreatment

[0060] 1.1 Ingredients: Weigh pregelatinized starch and microcrystalline cellulose according to the formula, pass through 80-mesh sieve respectively, and set aside.

[0061] 1.2 Preparation of adhesive solution: Add the formula amount of midanacin to 480g of 95% ethanol, stir to dissolve, slowly add 28g of povidone K30 to disperse evenly, stir to dissolve, add 600g of purified water to stir evenly, set aside.

[0062] 2. Granulation, drying, granulation

[0063] 2.1 Mix microcrystalline cellulose and pregelatinized starch, slowly add midanacin povidone K30 ethanol aqueous solution to make soft material, and granulate with 20 mesh.

[0064] 2.2 Place the wet granules in a decompression drying oven, dry at 50°C until the moisture content of the granules is not higher than 5%, and granulate with 20 mesh.

[0065] 3. Total mix

[0066] Get the granule and ...

Embodiment 3

[0073] Tablet formulation (10000 formulation units):

[0074]

[0075] Preparation Process:

[0076] 1. Pretreatment

[0077] 1.1 Ingredients: Weigh pregelatinized starch and microcrystalline cellulose according to the formula, pass through 80-mesh sieve respectively, and set aside.

[0078] 1.2 Preparation of adhesive solution: Add the formula amount of midanacin to 48g of 95% ethanol, stir to dissolve, slowly add 21g of povidone K30 to disperse evenly, stir to dissolve, add 60g of purified water to stir evenly, set aside.

[0079] 2. Granulation, drying, granulation

[0080] 2.1 Take part of microcrystalline cellulose, slowly add midanacin povidone K30 ethanol solution to make soft material, and granulate with 20 mesh.

[0081] 2.2 Place the wet granules in a decompression drying oven, dry at 50°C until the moisture content of the granules is no higher than 5%, and granulate with 60 mesh.

[0082] 3. Total mix

[0083] The granules were mixed with the remaining micro...

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Abstract

The invention discloses a tablet containing imidafenacin and a preparation method thereof. The tablet or a tablet core contains an active ingredient imidafenacin, a filling agent, an adhesive and a lubricating agent. The preparation method comprises the following steps: dissolving the active ingredient into an ethanol solvent or a mixed solvent of ethanol and water; adding the adhesive and water to prepare an adhesive solution; and granulating and tabletting with the filling agent and the lubricating agent. According to the method disclosed by the invention, the finished product can be rapidlydissolved out, and the raw materials and the adhesive are dissolved in the ethanol solution in steps and added into other mixed powder in a solution state, so that the content uniformity can be greatly improved; and a reduced pressure drying process is adopted to isolate from air, and the oxidative degradation impurities can be well reduced. According to the technical scheme, the tablet disclosedby the invention has the advantages of being rapid in dissolution, less in oxidative impurities, excellent in content uniformity and the like, and the preparation process is simple and suitable for large-scale production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a midanacin tablet and a preparation method thereof. Background technique [0002] Overactive bladder (OAB) is a syndrome characterized by urinary urgency symptoms, often accompanied by frequency, urgency, and nocturia, or accompanied by urge incontinence, which seriously reduces the quality of life of patients. About 50-100 million people worldwide suffer from overactive bladder, which is more common than diabetes and peptic ulcer. Midanacin has a diphenylbutanamide structure and is a new type of high-efficiency anticholinergic drug, which selectively acts on M3 and M1 receptors, blocks the contraction effect of choline on detrusor muscle, and has fewer central and peripheral adverse reactions. Midana's new film (trade name ) was launched in Japan in June 2007 with a specification of 0.1mg. [0003] Due to the extremely small size of this product, it is necessar...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/30A61K47/32A61K47/36A61K47/38A61K31/4174A61P13/10
CPCA61K9/2027A61K9/2054A61K9/2059A61K9/2095A61K9/282A61K31/4174
Inventor 石文晶蔡信用王华娟辛妮
Owner NANJING HEALTHNICE MEDICAL TECH
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