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Imidafenacin pharmaceutical composition with improved oral-taking absorbency

A technology of midanacin and its composition, which is applied in the field of midanacin pharmaceutical composition and its preparation, can solve the problems of low release rate, poor particle fluidity, sticky punching, etc. Bioavailability, effects of process maturity

Inactive Publication Date: 2013-01-09
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The conventional preparation method in the prior art prepares the new preparation of midana. Due to the physical and chemical properties of the new material of midana, it is easy to cause the particles in the prepared tablet to have poor fluidity, sticky punching, unqualified appearance of the tablet, and low release rate.
Cannot be mass-produced
[0010] In order to improve product quality and overcome the problem of incapable of industrialized production, we have carried out a lot of design and research on technical solutions, selected the optimal prescription and process, and solved the above technical defects

Method used

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  • Imidafenacin pharmaceutical composition with improved oral-taking absorbency
  • Imidafenacin pharmaceutical composition with improved oral-taking absorbency

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0078] Embodiment 1 (prior art)

[0079] (1) Prescription

[0080] Midana New 4g

[0081] Crospovidone 10g

[0082] Microcrystalline Cellulose 50g

[0083] Pregelatinized starch 20g

[0084] Magnesium Stearate 1g

[0085] 5% povidone absolute ethanol appropriate amount

[0086] Made 40000 pieces

[0087] (2) Preparation method

[0088] 5) Pulverize the midazine, sieve, and set aside; sieve the microcrystalline cellulose, crospovidone, pregelatinized starch and magnesium stearate, respectively, and set aside;

[0089] 6) Weigh the raw and auxiliary materials according to the prescription amount respectively, and set aside;

[0090] 7) Take the uniformly mixed raw and auxiliary materials and use 50% ethanol solution to granulate with a 20-mesh sieve, dry at 50°C, and dry for 20

[0091] Mesh sieve whole grain;

[0092] 8) According to the content, adjust the filling amount and press the tablet.

Embodiment 2

[0094] (1) Prescription

[0095] Composition 1

[0096] Midana New 4g

[0097] Alpha cyclodextrin 25g

[0098] Composition 2

[0099] Crospovidone 20g

[0100] Microcrystalline Cellulose 50g

[0101] Pregelatinized starch 20g

[0102] Magnesium Stearate 1g

[0103] 5% povidone absolute ethanol solution appropriate amount

[0104] Made 40000 pieces

[0105] (2) Preparation method

[0106] 1) Spray-dry the aqueous solution of midanacine and α-cyclodextrin to obtain spray-dried granules, mix the spray-dried granules with a water-soluble diluent to obtain a premix, mix the premix with a lubricant and finally The mixture is obtained and directly compressed into tablets;

[0107] 2) Sieve microcrystalline cellulose, croscarmellose sodium, pregelatinized starch, crospovidone and magnesium stearate respectively, use 5% povidone absolute ethanol solution, mix well, and prepare Form into 30-40 mesh granules, dry below 50°C, granulate, add lubricant, mix evenly, and directly c...

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Abstract

The invention relates to an imidafenacin pharmaceutical composition with improved oral-taking absorbency, which is characterized by comprising the following components of imidafenacin and Alpha-cyclodextrin, as a first part; and crospovidone, microcrystalline cellulose, pregelatinized starch, magnesium stearate and 5% povidone anhydrous ethanol solution, as a second part.

Description

technical field [0001] The invention relates to a midanacin pharmaceutical composition and a preparation method thereof. Dispersing midanacin in α-cyclodextrin can greatly increase the release rate in vitro, thereby improving the bioavailability. Background technique [0002] Overactive bladder (OAB) is a common condition characterized by urinary urgency, with or without urge incontinence, often accompanied by frequency and nocturia. The symptoms of OAB are caused by the involuntary contraction of the detrusor muscle during bladder filling. The etiology is still not very clear. It may be caused by damage to the central inhibitory efferent pathway, the peripheral sensory afferent pathway or the bladder muscle itself. . [0003] The number of patients worldwide is about 50 million to 100 million. There are slightly more women than men in patients, and the incidence rate increases with age. At present, there is no epidemiological data of this disease in our country, but the...

Claims

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Application Information

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IPC IPC(8): A61K31/4164A61K9/20A61K47/32A61K47/38A61P13/10
Inventor 严洁李轩
Owner TIANJIN HANKANG PHARMA BIOTECH