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Darifenacin sustained release preparation and preparation method thereof

A new technology of sustained-release preparation, darfina, which is applied in the direction of medical preparations with non-active ingredients, pharmaceutical formulas, and medical preparations containing active ingredients, etc., which can solve the problem of slow onset of action

Active Publication Date: 2012-07-25
COSCI MED TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Imipramine, a central nervous system drug, not only has anticholinergic sympathomimetic effects, but also centrally inhibits the voiding reflex. It is recommended for mixed urgency-stress urinary incontinence. Disadvantages: slow onset, take for several weeks only after

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Embodiment 1: Darfinacine Sustained-release Tablets

[0024] Darfenacin

75.0g

sodium alginate

80.0g

Calcium hydrogen phosphate

37.0g

Povidone K30

7.0g

water

Appropriate amount

[0025] Magnesium stearate

1.0g

Co-made

1000 pieces

[0026] Preparation:

[0027] Mix the main ingredients in the prescription, sodium alginate, calcium hydrogen phosphate, and povidone K30, add water as a wetting agent, granulate, dry at 50°C, granulate with a 20-mesh sieve, add magnesium stearate, and compress into tablets.

Embodiment 2

[0028] Embodiment 2: Darfinacine Sustained-release Tablets

[0029] Darfenacin

10.0g

Chitosan

10.0g

carnauba wax

10.0

Calcium hydrogen phosphate

164.0g

Povidone K30

5.0g

water

Appropriate amount

Magnesium stearate

1.0g

Co-made

1000 pieces

[0030] Preparation:

[0031] 1. The main drug darfenacin is micronized, with a particle size of 10 μm;

[0032] 2. Mix the main ingredients in the prescription, chitosan, carnauba wax, calcium hydrogen phosphate, and povidone K30, then add water as a wetting agent, granulate, dry at 50°C, granulate with a 20-mesh sieve, and then add stearic acid Magnesium, compressed.

Embodiment 3

[0033] Embodiment 3: Darfinacine Sustained-release Tablets

[0034] Darfenacin

100.0g

Alginic acid

50.0g

microcrystalline cellulose

44.0g

Povidone K30

5.0g

water

Appropriate amount

Magnesium stearate

1.0g

Co-made

1000 pieces

[0035] Preparation:

[0036] 1. The main drug darfenacin is micronized, with a particle size of 10 μm;

[0037] 2. Mix the main ingredients in the prescription, alginic acid, microcrystalline cellulose, and povidone K30, add water as a wetting agent, granulate, dry at 50°C, granulate with a 20-mesh sieve, add magnesium stearate, and press into tablets .

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PUM

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Abstract

The invention provides a darifenacin sustained release preparation with good patient compliance, small side effect and lasting and stable pesticide effect and a preparation method of the darifenacin sustained release preparation. The darifenacin sustained release preparation comprises a main medicine and a pH-sensitive high polymer; furthermore, when darifenacin and auxiliary materials are prepared into tablets or pellets, the high polymer can be as a coating material to prepare a sustained release coating. The darifenacin sustained release preparation further comprises a hydrophobic substrate. The hydrophobic substrate can be selected according to requirements of a preparation, can be a filling agent, a lubricating agent and the like and further can be a sustained release framework material; furthermore, the hydrophobic substrate can control release of the darifenacin with the high polymer together.

Description

technical field [0001] The invention relates to a darfinacine sustained-release preparation and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Overactive bladder (OAB) is a common disease, which is a syndrome with frequent urination, urgency and urge incontinence as the main symptoms. The Urinary Continence Group of the Urology Branch of the Chinese Medical Association defines Overactive Bladder Clinical Guidelines as: OAB is a symptom composed of frequent urination, urgency, and urge urinary incontinence. These symptoms can appear alone or in any combination. form appears. The etiology is still not very clear, it may be due to central inhibitory efferent pathways, peripheral sensory afferent pathways or damage to the bladder muscle itself, these reasons can exist alone or in combination. Causes of exercise urge incontinence include: 1. Urinary tract obstruction below the bladder; 2. Nervous syst...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K9/52A61K31/4025A61K47/32A61K47/34A61K47/36A61P13/10
Inventor 蒋海松王锦刚
Owner COSCI MED TECH CO LTD
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