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Method for preparing darifenacin hydrobromide sustained release tablets and use thereof

A technology of darfinacine hydrobromide and sustained-release tablets, which is applied in the new field of medicine, can solve the problems of no patent application for this product, no darfinacine hydrobromide sustained-release tablet being marketed, etc., and the method is simple, Stable and high-quality effects

Inactive Publication Date: 2009-07-01
BEIJING HOPE HUGE PHARM SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] At present, there is no darfenacine hydrobromide sustained-release tablet on the market in China, and there is no patent application for this product

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Embodiment 1: specification 1000 pieces

[0037] prescription:

[0038] Darfenacin Hydrobromide 10g

[0039] Acrylic resin No. 3 30g

[0040] Hydroxypropyl Methyl Cellulose K 4M 20g

[0041] Microcrystalline Cellulose 90g

[0042] Lactose 50g

[0043] PEG6000 80g

[0044] 2% pvp ethanol solution appropriate amount

[0045] Magnesium Stearate Appropriate amount

[0046] Prescription of coating solution

[0047] Hydroxypropyl Methyl Cellulose 5g

[0048] Polyethylene glycol 400g

[0049] Talc powder 1.5g

[0050] Distilled water 30ml

[0051]80% ethanol solution to 100ml

[0052] Preparation method:

[0053] Pass darfinesin hydrobromide through a 120 mesh sieve, weigh the darfinesine hydrobromide of the prescription ratio, acrylic resin No. 3, microcrystalline cellulose, HPMC K 4M , lactose, and PEG6000 are mixed evenly, and the soft material is made with 2% pvp ethanol liquid. Granulate with 18-mesh sieve, dry at 70-80°C, granul...

Embodiment 2

[0054] Embodiment 2: specification 10000 pieces

[0055] prescription:

[0056] Darfenacin Hydrobromide 100g

[0057] Acrylic resin No. 3 300g

[0058] Hydroxypropyl Methyl Cellulose K 4M 200g

[0059] Microcrystalline Cellulose 900g

[0060] Lactose 500g

[0061] PEG6000800g

[0062] 2% pvp ethanol solution appropriate amount

[0063] Magnesium Stearate Appropriate amount

[0064] Prescription of coating solution

[0065] Hydroxypropyl Methyl Cellulose 50g

[0066] Polyethylene glycol 4000g

[0067] Talc powder 15g

[0068] Distilled water 300ml

[0069] 80% ethanol solution to 1000ml

[0070] Preparation method:

[0071] Pass darfinesin hydrobromide through a 120 mesh sieve, weigh the darfinesine hydrobromide of the prescription ratio, acrylic resin No. 3, microcrystalline cellulose, HPMC K 4M , lactose, and PEG6000 are mixed evenly, and the soft material is made with 2% pvp ethanol liquid. Granulate with 18-mesh sieve, dry at 70-80...

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PUM

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Abstract

The invention belongs to the novel technical field of medicament, relates to a novel formulation of drifenacin hydrobromide applied to the treatment of overactive bladder accompanied by urinary incontinence, urgency of micturition, and frequent micturition. The characteristic of the novel preparation is that the invention is sustained-release tablet. Each tablet contains 3mg-30mg [of] drifenacin hydrobromide, preferably 5-20mg. The inventive medicament releases slowly to maintain comparatively stable blood concentration and longer acting time. The invention has reduced toxicity and side effect and is more convenient to take.

Description

technical field [0001] The invention belongs to the field of new medicine technology, and relates to a new dosage form of darfenazine hydrobromide, a pharmaceutical preparation for treating overactive bladder accompanied by symptoms of urgency urinary incontinence, urgency, and frequent urination, and a preparation method thereof. Specifically, it relates to a preparation method and application of darfinacine hydrobromide sustained-release tablets. Background technique [0002] As we age, the bladder's sphincter, which controls the flow of fluid, tends to weaken in strength. In addition, the sensory sensitivity of the bladder is reduced in the elderly, which means that they have no warning before urination, and the urgency of urination occurs. As people enter old age, frequent urination or nocturia often occurs. [0003] (1) Frequent urination: Physiological frequent urination: seen in excessive drinking water, mental stress or climate change. Pathological frequent urinat...

Claims

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Application Information

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IPC IPC(8): A61K31/4025A61K9/22A61P13/10
Inventor 王翰斌
Owner BEIJING HOPE HUGE PHARM SCI
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