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Nasal gel composite and preparation method thereof

A technology for gel and nasal use, which is applied in the field of chemical pharmaceuticals, and can solve the problems of inability to self-administer drugs, high cost, and unfavorable patient acceptance.

Inactive Publication Date: 2014-05-14
SHENZHEN JYMED TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The current method of administration is intrathecal infusion. Although the onset is quick, intrathecal administration can easily cause adverse reactions such as numbness and pain in both lower limbs, headache, dizziness, nausea, vomiting, fever, and convulsions, especially numbness and pain in both lower limbs. The most common, and can not self-administration, high cost, not conducive to patient acceptance, medication limitations
[0003] In addition, injection administration needs to be completed by professionals, which is not suitable for self-administration, but the use of nasal gel overcomes this limitation and is convenient for administration.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0011] The formulation of Ziconotide Nasal Gel is: 1.0% Ziconotide, 0.5% Carbomer, 0.5% Disodium EDTA, 1.0% Sodium Chloride, 10% Glycerin, 0.30% Tertiary Trichloride butanol, sodium hydroxide to adjust the pH to 6.5.

[0012] Its preparation process is as follows: Weigh the prescribed amount of carbomer, add water, stir to make it fully swell, then add the prescribed amount of Ziconotide, and the prescribed amount of disodium edetate, sodium chloride, glycerin, trisodium Mix chlorobutanol, add water and stir evenly, adjust pH to 6.5 with sodium hydroxide to obtain a gel, stir for 30 minutes to obtain ziconotide nasal gel.

[0013] Ziconotide nasal gel and ziconotide intrathecal infusion were prepared according to this example, and their pharmacokinetics and bioavailability were investigated through animal experiments.

[0014] 10 adult, healthy Beagle dogs were divided into two groups at once, with 5 dogs in each group. The above-mentioned nasal gel of ziconotide and intrath...

Embodiment 2

[0021] Ziconotide nasal gel formula is: 5.0% Ziconotide, 1.5% Carbomer, 1.2% 2-hydroxypropyl-β-cyclodextrin, 2.0% potassium chloride, 8.0% ethanol, 0.50 % benzalkonium chloride, sodium bicarbonate to adjust the pH to 7.0.

[0022] The preparation process is as follows: Weigh the prescription amount of carbomer, add water, stir to make it fully swell, then add the prescription amount of 2-hydroxypropyl-β-cyclodextrin, potassium chloride, ethanol, benzalkonium chloride and mix , add water and stir evenly, adjust the pH to 7.0 with sodium bicarbonate to obtain a gel, stir for 30 minutes, and obtain ziconotide nasal gel.

[0023] Ziconotide nasal gel and ziconotide intrathecal infusion were prepared according to this example, and their pharmacokinetics and bioavailability were investigated through animal experiments.

[0024] 10 adult, healthy Beagle dogs were divided into two groups at once, with 5 dogs in each group. The above-mentioned nasal gel of ziconotide and intrathecal ...

Embodiment 3

[0031] The formulation of Ziconotide Nasal Gel is: 10.0% Ziconotide, 1.5% Carbomer, 2.0% Tween 80, 2.0% Mannitol, 10% Propylene Glycol, 0.5% Benzoic Acid, and triethanolamine to adjust the pH to 6.8.

[0032] Its preparation process is as follows: Weigh the prescription amount of carbomer, add water, stir to make it fully swell, then add the prescription amount of Tween 80, mannitol, propylene glycol, and benzoic acid to mix, add water and stir well, adjust the pH with triethanolamine to 6.8 Get the gel, stir for 30 minutes to get Ziconotide Nasal Gel.

[0033] Ziconotide nasal gel and ziconotide intrathecal infusion were prepared according to this example, and their pharmacokinetics and bioavailability were investigated through animal experiments.

[0034] 10 adult, healthy Beagle dogs were divided into two groups at once, with 5 dogs in each group. The above-mentioned nasal gel of ziconotide and intrathecal instillation of ziconotide were administered to the two groups of ...

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PUM

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Abstract

The invention belongs to the field of chemicals, and relates to a Ziconotide-nasal gel composite and a preparation method thereof. The preparation is composed of Ziconotide, a gel matrix and pharmaceutical acceptable other auxiliary materials including an absorption enhancer, an osmotic pressure regulator, a moisturizing agent, an antioxidant, a preservative and a pH regulator. The preparation is mainly used for treating intolerable or invalid serious chronic pains such as generalized pain and the like. The preparation is simple in preparation process, convenient to take, rapid in onset, high in bioavailability, and beneficial to being accepted by patients.

Description

technical field [0001] The invention relates to the technical field of chemical pharmacy, in particular to ziconotide nasal gel. Background technique [0002] Ziconotide contains 25 amino acids and is the first neuron-specific N-type voltage-sensitive calcium ion channel blocker for clinical use. It was first launched in the United States in 2005. And get EU license. Its indications are mainly: It is used for patients with severe chronic pain who are suitable for intrathecal injection and cannot tolerate or fail other treatments (such as systemic analgesics, adjuvant therapy or intrathecal morphine). The current method of administration is intrathecal infusion. Although the onset is quick, intrathecal administration can easily cause adverse reactions such as numbness and pain in both lower limbs, headache, dizziness, nausea, vomiting, fever, and convulsions, especially numbness and pain in both lower limbs. The most common, and can not self-administration, high cost, not c...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/17A61K9/06A61K9/12A61P25/04
Inventor 姚志勇支钦李新宇付玉清邱焕杰李云开张建松
Owner SHENZHEN JYMED TECH
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