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A kind of fentanyl gel preparation and preparation method thereof

A technology of fentanyl gel and preparation, which is applied in the field of chemical pharmacy, can solve the problems of poor drug release, drug crystallization, residual fentanyl, etc., and achieve the effects of improving absorption rate, pain relief, and stable and reliable preparation quality

Inactive Publication Date: 2015-10-28
王丽丽
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, acrylic adhesives generally have poor drug release, causing a problem that a desired level of drug release can only be achieved by increasing the content of the main drug (Patent Document 1)
Increased primary drug content leads to other problems such as crystallization of the primary drug during storage and residual fentanyl in the formulation after administration

Method used

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  • A kind of fentanyl gel preparation and preparation method thereof
  • A kind of fentanyl gel preparation and preparation method thereof
  • A kind of fentanyl gel preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028]

[0029]

[0030] Preparation process

[0031] Put the carbomer in purified water with 50% of the total prescription and soak for 24 hours. Dissolve tromethamine in water with 10% of the total dosage of the prescription for subsequent use. Put fentanyl in ethanol and stir to disperse evenly, add tromethamine aqueous solution and stir to dissolve until the solution is completely clear, set aside. Stir and dissolve edetate disodium and the remaining purified water until there are no visible particles, and set aside; filter the swollen carbomer 940 through 120 mesh, and add the prescribed amount of propylene glycol, polyethylene glycol 400, edetate di The sodium solution and the fentanyl solution are added to the carbomer. Stir for 15 minutes; add triethanolamine into the carbomer base, stir for 30 minutes, control the pH at 7.3-8.5, stop stirring, fill, pack, and obtain the fentanyl gel.

Embodiment 2

[0033] The fentanyl raw material is prepared into fentanyl gel according to the following prescription:

[0034]

[0035]

[0036] Put the carbomer in purified water with 50% of the total prescription and soak for 24 hours. Dissolve tromethamine in water with 10% of the total dosage of the prescription for subsequent use. Put fentanyl in ethanol and stir to disperse evenly, add tromethamine aqueous solution and stir to dissolve until the solution is completely clear, set aside. Stir and dissolve edetate disodium and the remaining purified water until there are no visible particles, and set aside; filter the swollen carbomer 940 through 120 mesh, and add the prescribed amount of propylene glycol, polyethylene glycol 400, edetate di The sodium solution and the fentanyl solution are added to the carbomer. Stir for 15 minutes; add triethanolamine into the carbomer base, stir for 30 minutes, control the pH at 7.3-8.5, stop stirring, fill, pack, and obtain the fentanyl gel. ...

Embodiment 3

[0038] The fentanyl raw material is prepared into fentanyl gel according to the following prescription:

[0039]

[0040]Put the carbomer in purified water with 50% of the total prescription and soak for 24 hours. Dissolve tromethamine in water with 10% of the total dosage of the prescription for subsequent use. Put fentanyl in ethanol and stir to disperse evenly, add tromethamine aqueous solution and stir to dissolve until the solution is completely clear, set aside. Stir and dissolve edetate disodium and the remaining purified water until there are no visible particles, and set aside; filter the swollen carbomer 940 through 120 mesh, and add the prescribed amount of propylene glycol, polyethylene glycol 400, edetate di The sodium solution and the fentanyl solution are added to the carbomer. Stir for 15 minutes; add triethanolamine into the carbomer base, stir for 30 minutes, control the pH at 7.3-8.5, stop stirring, fill, pack, and obtain the fentanyl gel.

[0041] Bio...

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Abstract

The invention provides a fentanyl gel preparation and a preparation method thereof. The gel preparation comprises the following components in percentage by weight: 0.05-5 percent of fentanyl, 0.3-1.5 percent of carbomer940, 0.1-1 percent of tromethamine, 1-10 percent of ethanol, 5-15 parts of propylene glycol, 0.5-2.0 percent of polyethylene glycol400, 0.005-0.016 percent of edetate disodium and 1.0-2.5 percent of triethanolamine. According to the preparation method, tromethamine is adopted to dissolve fentanyl, so that the problem that fentanyl is not dissolved in water can be solved, the penetrability of fentanyl to skin can be improved, the transdermal absorption of fentanyl can be improved, the curative effecton local pain by local external administration can be remarkably improved, and a novel administration means is provided to patients. The gel preparation is a half-solid gel with good transdermal absorption, fentanyl can be completely dissolved and dispersed in the gel, pains of a patient can be relieved; the preparation process is simple, and the preparation quality is stable and reliable.

Description

field of invention [0001] The invention relates to the field of chemical pharmacy, in particular to a fentanyl gel preparation and a preparation method thereof. Background of the invention [0002] Fentanyl and Fentanyl citrate are synthetic narcotic analgesics that have been shown to be approximately 200 times more potent in analgesic activity than morphine in animal experiments. Currently, a depot-type long-acting preparation containing fentanyl for percutaneous absorption type is commercially available for alleviating pain caused by cancer, which can actually maintain the fentanyl blood concentration M to 72 at an effective level. Hour. [0003] However, the disadvantage of these depot-type long-acting formulations for transdermal absorption is that the drug is absorbed rather slowly after administration, and blood levels reach effective levels only after 12 to 24 hours after the initial administration, therefore, they cannot produce an immediate effect. Analgesic effec...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/06A61K31/4468A61K47/18A61P29/00
Inventor 王丽丽刘燕王传林薛娟孙永国
Owner 王丽丽