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Aripiprazole oral instant film agent and preparation method thereof

An oral instant film agent and oral instant film technology are applied in pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., which can solve problems such as inconvenient administration and improve the uniformity of appearance and smoothness, rapid disintegration, and the effect of solving dysphagia

Pending Publication Date: 2020-11-17
安浩医药科技(上海)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The present invention aims to provide a kind of aripiprazole oral instant dissolving film that can solve the above-mentioned technical problems. The film has uniform color, uniform thickness and stable properties. Overcome the inconvenient administration of aripiprazole as a tablet and the poor compliance of patients with Tibetan medicine vomiting

Method used

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  • Aripiprazole oral instant film agent and preparation method thereof
  • Aripiprazole oral instant film agent and preparation method thereof
  • Aripiprazole oral instant film agent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Embodiment 1: Preparation of oral instant film blank film

[0044]

[0045] *removed during drawdown drying

[0046] Process:

[0047] the above amount RS 720, PEG400 and citric acid were added to 30 g of purified water under stirring, and stirred to dissolve to obtain a glue for coating. Use the above glue to coat a film of a certain thickness on a horizontal mold and place it in an oven to heat and blow dry. After drying, peel the film from the mold and divide it into 2cm*2cm sizes, then pack it to get the product.

Embodiment 2

[0048] Embodiment 2: Preparation of oral instant film blank film

[0049]

[0050] *removed during drawdown drying

[0051] Process:

[0052] the above amount Add RS 780 and PEG400 into 50g of purified water under stirring condition, stir and dissolve to obtain glue for coating. Use the above glue to coat a film of a certain thickness on a horizontal mold and place it in an oven to heat and blow dry. After drying, peel the film from the mold and divide it into 2cm*2cm sizes, then pack it to get the product.

Embodiment 3

[0053] Embodiment 3: the preparation of oral instant film blank film

[0054] components Weight (g) PVA 9.0 glycerin 1.7 citric acid 0.5 purified water* 60.0

[0055] *removed during drawdown drying

[0056] Process:

[0057] The above-mentioned amount of PVA was added to 60 g of purified water, heated and stirred in a constant temperature water bath at 60° C., and dissolved to obtain a glue for coating. Use the above glue to coat a film of a certain thickness on a horizontal mold and place it in an oven to heat and blow dry. After drying, peel the film from the mold and divide it into 2cm*2cm sizes, then pack it to get the product.

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Abstract

The invention belongs to the field of pharmaceutical preparations, and particularly relates to an aripiprazole oral instant film agent and a preparation method thereof. The film agent mainly comprisesthe following components in percentage by weight: 10-20% of aripiprazole, 40-90% of a water-soluble film-forming material, 5-30% of a plasticizer, 0-20% of a corrigent, and 0-10% of other auxiliary materials. According to the aripiprazole oral instant film agent disclosed by the invention, water-soluble polyvinyl alcohol and povidone are preferably selected as the film-forming material, and a proper plasticizer and a proper proportion thereof are screened, so that the oral instant film agent with good mechanical properties and disintegration time is prepared. The oral instant film agent overcomes the defect that most oral solid preparations need water for administration, the oral cavity does not need to be chewed, the oral instant film agent can be directly adhered to an administration part after administration, disintegration is rapid, the oral instant film agent cannot be vomited, psychotic patients can be prevented from hiding and vomiting medicines, the production process is simple, the cost is low, almost no dust flies in the production process, and the problems of labor protection and environmental pollution can be solved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an aripiprazole oral instant film and a preparation method thereof. Background technique [0002] [0003] Aripiprazole as shown in the above structure is a third-generation atypical antipsychotic drug, which has obvious curative effects on the recessive and positive symptoms of schizophrenia, has a rapid onset of action, and is safe. It was approved by the U.S. FDA on November 15, 2002 It has been approved for the treatment of schizophrenia, and the dosage forms currently on the market include immediate-release tablets, orally disintegrating tablets, oral liquids, and sustained-release intramuscular injections. [0004] In the acute phase of schizophrenia and the manic phase of bipolar disorder, patients often refuse to take medicine. Tibetan medicine and vomiting medicine in the mouth are the most common, and compliance problems are common. Therefore, ...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/496A61K47/32A61K47/36A61K47/38A61P25/18
CPCA61K31/496A61K9/7007A61K9/006A61K47/32A61K47/38A61K47/36A61P25/18
Inventor 方琪李宁
Owner 安浩医药科技(上海)有限公司