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Transdermal plaster of rivastigmine and preparation process thereof

A technology of transdermal patch and penetration enhancer, applied in the field of pharmacy, can solve the problems of gastrointestinal adverse reactions of large liver first-pass effect, inconvenience in patients with Alzheimer's disease, single dosage form, etc. The phenomenon of peak and valley of blood drug concentration and the effect of reducing the number of doses

Inactive Publication Date: 2011-03-16
SHANGHAI INST OF PHARMA IND CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The existing dosage forms are oral liquid and capsules developed by Novartis Pharmaceuticals, of which the capsules have been imported, and the trade name is Exelon, but the price is expensive, and it is administered twice a day
Due to the single dosage form of rivastigmine, there is a large hepatic first-pass effect and some gastrointestinal adverse reactions, and oral administration is very inconvenient for senile dementia patients, so it is necessary to improve the existing dosage form

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] The transdermal patch described in this example is an adhesive matrix patch, consisting of a backing layer, a protective layer, and a drug-containing adhesive matrix (i.e., a drug reservoir). The materials used in each layer are as follows:

[0021] Backing layer: non-woven fabric

[0022] Protective layer: polyester film

[0023] Drug-containing viscose skeleton layer (calculated based on 100 stickers):

[0024] Polyacrylic resin pressure sensitive adhesive 30g

[0025] Rivastigmine 2g

[0026] Azone 1g

[0027] Among them, the polyacrylic resin pressure-sensitive adhesive preparation components are as follows:

[0028] Polyacrylic resin IV 20g

[0029] Succinic acid 1g

[0030] Dibutyl phthalate 10g

[0031] Acetone 80mL

[0032] Preparation process: 1. Preparation of polyacrylic acid resin pressure-sensitive adhesive: take the succinic acid of the prepared component amount and dissolve it with acetone, then add polyacrylic acid resin and stir to dissolve, and...

Embodiment 2

[0035] The transdermal patch described in this example is an adhesive skeleton patch, consisting of a three-layer structure of a backing layer, a protective layer, and a drug-containing adhesive skeleton. The materials used in each layer are as follows:

[0036] Backing layer: non-woven fabric

[0037] Protective layer: siliconized paper

[0038] Drug-containing viscose skeleton layer (calculated based on 100 stickers):

[0039] Acrylic pressure sensitive adhesive 35g

[0040] Rivastigmine 3g

[0041] Oleic acid 2g

[0042] Preparation process: Take the prescribed amount of acrylate pressure-sensitive adhesive, rivastigmine and oleic acid, add appropriate amount of ethyl acetate to dissolve, adjust to a suitable consistency, apply on the protective layer, control the thickness, dry at 60°C, and cover The backing layer can be cut into a suitable area.

Embodiment 3

[0044] The transdermal patch described in this example is an adhesive layer rate-limiting patch, consisting of a five-layer structure of a backing layer, a protective layer, a drug-containing adhesive skeleton, a release-controlling film, and an adhesive layer. The materials used in each layer are as follows :

[0045] Backing layer: polyester film

[0046] Protective layer: PTFE film

[0047] Controlled Release Membrane: Polyacrylic Microporous Membrane

[0048] Adhesive layer: blank silicone pressure sensitive adhesive

[0049]Drug-containing viscose skeleton layer (calculated based on 100 stickers):

[0050] Silicone pressure sensitive adhesive 30g

[0051] Rivastigmine 5g

[0052] Eucalyptol 1g

[0053] Preparation process: 1. Preparation of drug-containing skeleton layer: Dissolve silicone pressure-sensitive adhesive, rivastigmine and eucalyptol in ethyl acetate, coat on the backing layer, control the thickness, dry at 40-60°C, and then Cover the surface of the ske...

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PUM

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Abstract

The invention relates to a method for preparing kabalatin adhere agent for treating senile dementia, wherein said adhere agent can stably hold blood drug density and reduce feeding time, with high safety.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a rivastigmine transdermal patch which is convenient for senile dementia patients to take medicine and a preparation method thereof. Background technique [0002] With the aging of the population, the number of senile dementia patients is increasing year by year, becoming the fourth largest senile disease after heart, cerebrovascular diseases and malignant tumors. Most provinces and cities in China have entered into an aging population structure. According to the survey, the incidence rate of senile dementia patients over the age of 60 is 5%, 10% over the age of 75, and 25% over the age of 85. Since the pathogenesis of senile dementia is still not very clear, there is no effective drug to completely cure senile dementia, and it only plays a role in improving cognition and delaying deterioration. Cholinesterase inhibitors are currently the mainstream drugs for the treatment of senile deme...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/27A61K9/70A61K47/06A61K47/30
Inventor 沈航孝顾林金徐惠南
Owner SHANGHAI INST OF PHARMA IND CO LTD
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