Transdermal plaster of rivastigmine and preparation process thereof

A transdermal patch and patch technology, applied in the field of pharmacy, can solve the problems of large liver first-pass gastrointestinal adverse reactions, inconvenience in patients with senile dementia, single dosage form, etc., to avoid liver first-pass effect and blood loss. The effect of drug concentration peak and valley phenomenon and reducing the number of doses

Inactive Publication Date: 2007-07-11
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 embodiment is an adhesive skeleton type patch, which is composed of a three-layer structure of a backing layer, a protective layer and a drug-containing adhesive skeleton (that is, a drug reservoir). The materials used in each layer are as follows:

[0021] Backing layer: non-woven fabric

[0022] Protective layer: polyester film

[0023] Medicated viscose skeleton layer (calculated by 100 sticks):

[0024] Polyacrylic resin pressure sensitive adhesive 30g

[0025] Rivastigmine 2g

[0026] Azone 1g

[0027] The components of the polyacrylic resin pressure-sensitive adhesive 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 resin pressure-sensitive adhesive: Dissolve the succinic acid of the prepared component with acetone, then add polyacrylic resin and stir to dissolve, and finally add...

Embodiment 2

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

[0036] Backing layer: non-woven fabric

[0037] Protective layer: siliconized paper

[0038] Medicated viscose skeleton layer (calculated by 100 sticks):

[0039] Acrylic Pressure Sensitive Adhesive 35g

[0040] Rivastigmine 3g

[0041] Oleic acid 2g

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

Embodiment 3

[0044] The transdermal patch described in this example is an adhesive layer speed-limiting type patch, which is composed of a five-layer structure of a backing layer, a protective layer, a drug-containing adhesive skeleton, a controlled release 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]Medicated viscose skeleton layer (calculated by 100 sticks):

[0050] Silicone pressure sensitive adhesive 30g

[0051] Rivastigmine 5g

[0052] Cineole 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 skeleton...

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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 medication 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, and it has become the fourth largest senile disease after heart, cerebrovascular diseases and malignant tumors. Most provinces and cities in China have entered an elderly population structure. According to a survey, the incidence of Alzheimer's patients is 5% over the age of 60, 10% over the age of 75, and 25% over the age of 85. Since the pathogenesis of Alzheimer's disease is not very clear, there is no effective drug to completely cure Alzheimer's disease, which only improves cognition and delays the deterioration. Cholinesterase inhibitors are the mainstream drugs currently on the market for the treatment of senile dementi...

Claims

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Application Information

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Patent Type & Authority Applications(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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