Aripiprazole orally dissolving film and preparation method thereof

An aripiprazole and mouth-dissolving film technology is applied in the field of drug film preparations and their preparation, which can solve the problems of physical strength failing to meet the requirements for use, physical properties failing to meet the requirements, being easy to break, broken and the like, and to solve labor protection problems. and environmental pollution, excellent bioavailability, good stability

Active Publication Date: 2015-11-18
SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The dose of aripiprazole is 5mg or 10mg (usually about 10-25% of the total solids in the film); the polymer film-forming material in the prescription usually needs to account for at least 30% of the total solids in the film, otherwise the physical strength reaches Less than the use requirements; so the amount of cyclodextrin that can be added to the prescription is limited
If a sufficient amount of cyclodextrin is added to improve the solubility of the drug, it is necessary to reduce the amount of polymer film-forming materials in the prescription. The physical properties of the prepared film cannot meet the requirements, and it will be very brittle, easy to break, and broken

Method used

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  • Aripiprazole orally dissolving film and preparation method thereof
  • Aripiprazole orally dissolving film and preparation method thereof
  • Aripiprazole orally dissolving film and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] prescription:

[0048]

[0049] Preparation:

[0050] Take hydroxypropyl-β-cyclodextrin and add 30ml of 0.1M hydrochloric acid solution, stir to dissolve, then add aripiprazole, stir at 60°C for 1 hour, then add 300ml of purified water, then add titanium dioxide, HPMC and HPC, and stir Uniformly form a high-viscosity solution, pass through an 80-mesh sieve, remove insoluble matter, and vacuum defoam. Then spread the membrane solution on a stainless steel belt and dry at 80°C for 15 minutes. According to the content measurement results, cut into a certain size, peel off from the stainless steel belt, and seal the package.

[0051] The obtained drug film preparation has a thickness of 0.065 mm, and each tablet contains 5 mg or 10 mg of aripiprazole. Oral once a day, the initial dose is 5mg / day in the first week, and increased to 10mg / day in the second week. After 2 weeks of medication, the dose can be increased according to the individual's curative effect and toleran...

Embodiment 2

[0058] prescription:

[0059]

[0060] Preparation:

[0061] Take glucosyl-β-cyclodextrin and add 24ml of 0.1M hydrochloric acid solution, stir to dissolve, then add aripiprazole, stir at 60°C for 1 hour, then add 300ml of purified water, then add the rest of the excipients, stir evenly to form a high viscosity The solution is passed through an 80-mesh sieve to remove insoluble matter, and vacuum defoaming. Then spread the membrane solution on a stainless steel belt and dry at 90°C for 15 minutes. According to the content measurement results, cut into a certain size, peel off from the stainless steel belt, and seal the package.

[0062] The obtained drug film preparation has a thickness of 0.065 mm, and each tablet contains 5 mg or 10 mg of aripiprazole. Oral once a day, the initial dose is 5mg / day in the first week, and increased to 10mg / day in the second week. After 2 weeks of medication, the dose can be increased according to the individual's curative effect and toler...

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Abstract

The invention discloses an aripiprazole oral membrane and a preparation method thereof. The aripiprazole oral membrane contains cyclodextrin encapsulated aripiprazole, wherein the cyclodextrin is more than one of hydroxypropyl-beta-cyclodextrin and glucosyl-beta-cyclodextrin, and the weight ratio of the cyclodextrin to the aripiprazole is 1: 1 to 3: 1. The membrane preparation has the beneficial effects of even, smooth and clean membrane obtained, easy administration and direct administration without water, quick and safe dissolving-out, high absorption speed, high bioavailability, good curative effect, simple production process, low production cost, and high added value of products. The aripiprazole membrane is quick to dissolve out, good in stability and high in bioavailability, and excellent in bioavailability, and also good in compliance and popular with patients; the aripiprazole membrane is good in formability, and capable of directly adhering to the part to which the medicine is applied after administration, and thus cannot be spitted, and therefore, psychopaths can be prevented from spitting out and hiding the drug; and in the production process, almost no dust flies, and the problems of labor protection and environmental pollution can be solved.

Description

technical field [0001] The invention relates to an aripiprazole preparation, in particular to a drug film preparation and a preparation method thereof. Background technique [0002] Aripiprazole belongs to the third generation of atypical antipsychotics, which has a significant effect on both positive and negative symptoms of schizophrenia, and has very few side effects. The existing marketed dosage forms are mainly ordinary tablets and orally disintegrating tablets. Because schizophrenic patients often take Tibetan medicine and vomit medicine when taking medicine, it greatly affects the curative effect of medicine. The film preparation does not need to be taken with water, it dissolves immediately on the tongue, and sticks there and is not easy to spit out, thus improving the compliance of clinical medication, especially suitable for mental patients; and the production process is simple, energy consumption is less, and the cost is relatively low. Low. [0003] There have...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/70A61K31/496A61K47/48A61P25/18
Inventor 陈芳王栋海杨柳榴杨清敏王兵
Owner SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT
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