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Darifenacin hydrobromide sustained-release tablet and preparation method

A technology of darfenazine hydrobromide and sustained-release tablets, which is applied in the new field of medicine, can solve the problems of poor production controllability, increased material consumption, and small adjustable space, so as to reduce production costs, reduce material consumption, The effect of reducing production costs

Active Publication Date: 2011-05-11
SHANDONG CHUANGXIN PHARMA RES & DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the above method has achieved the ideal in vitro sustained release effect and bioavailability, the use of high weight and high proportion of blockers not only results in a great increase in the amount of materials used, thereby increasing the cost, but also makes the prescription adjustable. Small, poor production controllability

Method used

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  • Darifenacin hydrobromide sustained-release tablet and preparation method
  • Darifenacin hydrobromide sustained-release tablet and preparation method
  • Darifenacin hydrobromide sustained-release tablet and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment １

[0024] Carbomer 974P 5.6g

[0025] Calcium hydrogen phosphate 133.47g

[0026] Lactose 50.0g

[0027] Magnesium Stearate 2.0g

[0028] Total weight 200g

[0029] Makes 1000 pieces

[0030] Pass darfenacine hydrobromide, carbomer 974P, calcium hydrogen phosphate and lactose through an 80-mesh sieve, and mix them evenly with a three-dimensional mixer. Lubricant magnesium stearate is added to the above powder, mixed evenly in a three-dimensional mixer, f8mm shallow concave punched tablets, and coated with gastric-soluble coating powder.

[0031] Example 2

Embodiment 2

[0033] Carbomer 971P 2g

[0034] Calcium hydrogen phosphate 137.07g

[0035] Lactose 50.0g

[0036] Magnesium Stearate 2.0g

[0037] Total weight 200g

[0038] Makes 1000 pieces

[0039] Pass darfenacine hydrobromide, carbomer 971P, calcium hydrogen phosphate and lactose through an 80-mesh sieve, and mix them evenly in a three-dimensional mixer. Lubricant magnesium stearate is added to the above powder, mixed evenly in a three-dimensional mixer, f8mm shallow concave punched tablets, and coated with gastric-soluble coating powder.

[0040] Example 3

Embodiment 3

[0042] Carbomer 934P 10g

[0043] Calcium hydrogen phosphate 129.07g

[0044] Lactose 50.0g

[0045] Magnesium Stearate 2.0g

[0046] Total weight 200g

[0047] Makes 1000 pieces

[0048] Pass darfenacine hydrobromide, carbomer 934P, calcium hydrogen phosphate and lactose through an 80-mesh sieve, and mix them evenly in a three-dimensional mixer. Lubricant magnesium stearate is added to the above powder, mixed evenly in a three-dimensional mixer, f8mm shallow concave punched tablets, and coated with gastric-soluble coating powder.

[0049] Example 4

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PUM

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Abstract

The invention belongs to the field of new medicament technologies, and in particular relates to a darifenacin hydrobromide sustained-release tablet and a preparation method. The darifenacin hydrobromide sustained-release tablet adopts carbomer as a new retardant, and the dosage of the carbomer is 1-5% by weight of the preparation and can reach considerable vitro release and bioavailability compared with the dosage of the retardant in the prior art, which is more than half of the dosage of a prescription. The dosage of the retardant in the new method is greatly reduced so that the consumption of materials can be greatly reduced, the process is simpler, the controllability is better, the efficiency is improved, and the production cost is greatly reduced.

Description

technical field [0001] The invention belongs to the field of new medicine technology, and in particular relates to a darfinacin hydrobromide sustained-release tablet using carbomer as a blocking agent and a preparation method thereof. Background technique [0002] Darfenacine Hydrobromide Sustained-release Tablets are used for the treatment of overactive bladder (OAB) such as urinary incontinence, urgency and frequency of urination, and the US FDA approved Novartis Pharmaceuticals’ darfenacine hydrobromide on December 22, 2004 Extended-release tablets (Enablex ? ) listed. Darfenacin plays a role by blocking the M3 receptor that mainly responds to bladder muscle contraction. It is a potent muscarinic receptor blocker, which helps to reduce the incidence of urinary incontinence, increase bladder urine storage, and reduce the frequency of urination And reduce pressure and urgency to urinate. The M3 effect of darfenacine hydrobromide is unique among all OAB treatment drugs, a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K47/32A61K31/4025A61P13/10
Inventor 邢来田吕传涛秦玉荣阎志猛焦培想
Owner SHANDONG CHUANGXIN PHARMA RES & DEV
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