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Rivastigmine hydrogen tartrate dry suspension and preparation method thereof

A technology of rivastigmine bitartrate and dry suspension, which is applied in the field of rivastigmine bitartrate dry suspension and its preparation, which can solve the difficulty of increasing the care of family members, the high incidence of adverse reactions, and the inability to take care of themselves, etc. To achieve the effect of simplifying the difficulty of home care, reducing the incidence of adverse reactions, and improving the quality of life

Active Publication Date: 2022-03-11
ZHUOHE PHARM GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, the existing common oral preparations need to be administered in multiple doses, and the incidence of adverse reactions is relatively high
Since most of the patients with AD are elderly patients, they are usually unable to take care of themselves and have difficulty swallowing. The multiple doses of medication in a day also increase the difficulty of nursing care for family members.

Method used

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  • Rivastigmine hydrogen tartrate dry suspension and preparation method thereof
  • Rivastigmine hydrogen tartrate dry suspension and preparation method thereof
  • Rivastigmine hydrogen tartrate dry suspension and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] The rivastigmine bitartrate dry suspension disclosed in this example is used in the preparation of 1000 bags, 1.4 g per bag.

[0025] components Dosage (g) Rivastigmine Bitartrate 12 Amberlite IRP 69 100 Ethyl cellulose 30 castor oil 0.9 Polyvinylpyrrolidone K30 0.2 Poloxamer 200 Sodium carboxymethyl cellulose 800 colloidal silica 80 aspartame 100 apple flavor 50

[0026] The preparation method of above-mentioned rivastigmine bitartrate dry suspension is:

[0027] S1. Dissolve the prescribed amount of rivastigmine bitartrate in purified water, add 45-90 μm Amberlite IRP69, and react at 40°C for 10 hours. Filter, rinse the filtrate with purified water, and dry at 40°C to obtain the drug-loaded complex;

[0028] S2. Prepare an ethanol solution containing ethyl cellulose, castor oil, and polyvinylpyrrolidone K30, add the drug-loaded complex in step S1, and stir to disperse. Set the inlet air temp...

Embodiment 2

[0031] The rivastigmine bitartrate dry suspension disclosed in this example is used in the preparation of 1000 bags, 1.4 g per bag.

[0032]

[0033]

[0034] The preparation method of above-mentioned rivastigmine bitartrate dry suspension is:

[0035] S1. Dissolve the prescribed amount of rivastigmine bitartrate in purified water, add 45-90 μm Amberlite IRP69, and react at 40°C for 12 hours. Filter, rinse the filtrate with purified water, and dry at 40°C to obtain the drug-loaded complex;

[0036] S2. Prepare an ethanol solution containing ethyl cellulose, triethyl citrate, and polyethylene glycol 6000, add the drug-loaded compound in step (1), and stir to disperse. Set the air inlet temperature to 60°C, the centrifugal speed to 15000rpm, and start spray drying.

[0037] S3. Put the spray-dried product in S2 into a three-dimensional mixer together with sodium lauryl sulfate, sodium alginate, aspartame, orange essence, and colloidal silicon dioxide, mix evenly, and pac...

Embodiment 3

[0039] The rivastigmine bitartrate dry suspension disclosed in this example is used in the preparation of 1000 bags, 1.4 g per bag.

[0040]

[0041]

[0042] The preparation method of above-mentioned rivastigmine bitartrate dry suspension is:

[0043] S1. Dissolve the prescribed amount of rivastigmine bitartrate in purified water, add 45-90 μm Amberlite IRP69, and react at 40°C for 12 hours. Filter, rinse the filtrate with purified water, and dry at 40°C to obtain the drug-loaded complex;

[0044] S2. Prepare an ethanol solution containing ethyl cellulose, triethyl citrate, and galactose, add the drug-loaded compound in step (1), and stir to disperse. Set the inlet air temperature to 55°C, the centrifugal speed to 11000rpm, and start spray drying.

[0045] S3. Put the spray-dried product in S2 into a three-dimensional mixer together with poloxamer, sodium carboxymethylcellulose, sucralose, orange essence, and colloidal silicon dioxide, mix evenly, and pack in divided ...

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Abstract

The invention provides a rivastigmine hydrogen tartrate dry suspension. The rivastigmine hydrogen tartrate dry suspension is prepared from the following components: 1 to 35g of rivastigmine hydrogen tartrate, 10 to 700g of ion exchange resin, 1 to 100g of retardant material, 1 to 600g of wetting agent, 600 to 2000g of suspending aid, 3 to 120g of flow aid and 60 to 300g of flavoring agent. Wherein the weight ratio of the ion exchange resin to the rivastigmine hydrogen tartrate is (4: 1)-(16: 1). The invention also discloses a preparation method of the dry suspension. The invention discloses a rivastigmine hydrogen tartrate dry suspension with a slow release effect and a preparation method of the rivastigmine hydrogen tartrate dry suspension, and the rivastigmine hydrogen tartrate dry suspension can reduce the administration frequency, maintain stable blood concentration and reduce the occurrence rate of adverse reactions. Meanwhile, the medicine is orally taken in a liquid form, so that the nursing difficulty is simplified, and the patient compliance is improved.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to rivastigmine bitartrate dry suspension and a preparation method thereof. Background technique [0002] Alzheimer's disease (AD) is a degenerative disease of the central nervous system that occurs in old age and presenile age and is characterized by progressive cognitive dysfunction and behavioral impairment. Clinically, it is manifested as memory impairment, aphasia, apraxia, agnosia, visual-spatial ability impairment, abstract thinking and calculation impairment, personality and behavior changes, etc. AD is the most common type of dementia in old age and one of the most common chronic diseases, accounting for about 50%-70% of old age dementia. [0003] At present, there is no effective method for surgical treatment of AD, and patients can only delay the progression of AD disease by taking drugs for a long time. [0004] Rivastigmine Hydrogen Tartrate, the c...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K31/27A61K47/10A61K47/32A61K47/38A61P25/28
CPCA61K31/27A61K9/10A61K47/38A61K47/10A61K47/32A61P25/28Y02A50/30
Inventor 丁翔郁晨燕韩小霜张峰李晓明
Owner ZHUOHE PHARM GRP CO LTD
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