Darifenacin hydrobromide sustained-release capsules

A technology of darfenacine hydrobromide and sustained-release capsules, which is applied in the new field of medicine, can solve the problem of low drug withdrawal rate of patients, and achieve the effects of stable blood drug concentration, long action time, and extensive social and economic benefits

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

A total of 98 clinical studies involving more than 10,000 cases have been conducted on Enablex. The most common adverse reactions are dry mouth and constipation, and the rate of drug withdrawal due to adverse reactions is low.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

specific Embodiment approach

[0045] Specific embodiments are as follows, but do not limit the present invention in any way.

Embodiment

[0047] (1) Preparation of pill core

[0048] Darfenacin Hydrobromide 10g

[0049] Blank ball core 50g

[0050] 7% PVP solution (solvent is 90% ethanol) 30g

[0051] Talc powder 1.5g

[0052] Preparation Process:

[0053]Pass darfenazine hydrobromide through a 160-mesh sieve, weigh the prescription amount, and pour it into the lower hopper. Start the granulation coating machine, the air inlet pressure is 0.5bar, CYL (air inlet air pressure) 3bar, CAP1 (atomization pressure) 0.9bar, pour blank ball cores, granulate, feeding speed 4rpm, peristaltic pump 10%, Turn blue at 150rpm, and dry at 50°C. The granulation is finished, and the output is 65g.

[0054] (2) Eight kinds of specific prescriptions are as follows: (determine the type and quantity of sustained release agent)

[0055] Prescription A:

[0056] With pill core 500g

[0057] Ethylcellulose 2g

[0058] Stearic acid 5g

[0059] Diethyl phthalate 0.2g

[0060] Talc powder 10g

[0061] 95% ethanol 1000g

[0062...

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PUM

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Abstract

The invention belongs to the novel technical field of medicament and relates to a novel dosage form of darifenacin hydrobromide sustained release capsules used for treating urinary bladder with symptoms of urge urinary incontinence, urgent micturition and frequent micturition and composed of darifenacin hydrobromide, sugar spheres, sustained release agent, plasticizer and antisticking agent between which the weight ratio is 10:100:(0-20):(0-20):(0-25). Ethanol is used to prepare slurry, and weight of the antisticking agent is 1% that of the ethanol. The preparation technique comprises steps of preparing medicament containing spheres by granule coater, after drying, coating sustained release coating layer, drying by blowing, packing in hard capsules, thus obtaining the darifenacin hydrobromide sustained release capsules. The inventive Chinese traditional medicine is slowly released so as to maintain relatively stable blood concentration and longer action time, and has advantages of reducing side effect, more convenient administration etc.

Description

technical field [0001] The invention belongs to the field of new medicine technology, in particular to a darfenacine hydrobromide sustained-release capsule, which is used for treating overactive bladder accompanied by symptoms of urgency urinary incontinence, urgency and frequent urination. 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 urination:—increased frequency of urination and normal urine volume each time: seen in diabetes, diabetes insipidus, renal failure, polyuria period, etc. -Increased fr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4025A61K9/52A61K47/34A61K47/38A61P13/10
Inventor 王翰斌
Owner BEIJING HOPE HUGE PHARM SCI
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