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Oral instant film preparation containing 2-oxo-1-pyrrolidine derivative and preparation method and application thereof

A technology of oral instant film and derivatives, which is applied in the direction of medical preparations containing active ingredients, medical preparations with non-active ingredients, drug combinations, etc., can solve the problems of limited application functions and decreased mechanical properties of instant films. Achieve the effect of reducing clinical care costs, low cost, and short disintegration time limit

Pending Publication Date: 2021-06-15
武汉久安药物研究院有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the prior art, the oral instant film has the technical defect that as the content of the active ingredient increases during the preparation process, the mechanical properties decrease, resulting in the limitation of the comprehensive application function of the instant film, which cannot meet the needs of practical applications.

Method used

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  • Oral instant film preparation containing 2-oxo-1-pyrrolidine derivative and preparation method and application thereof
  • Oral instant film preparation containing 2-oxo-1-pyrrolidine derivative and preparation method and application thereof
  • Oral instant film preparation containing 2-oxo-1-pyrrolidine derivative and preparation method and application thereof

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preparation example Construction

[0075] The present invention also provides a preparation method of an oral instant film preparation comprising 2-oxo-1-pyrrolidine derivatives, comprising the following steps:

[0076] S1, dispersing a predetermined amount of highly water-soluble film-forming material into water at 70-90°C, stirring and dissolving to obtain a solution of highly water-soluble film-forming material, and then cooling to room temperature for later use;

[0077] S2, adding a predetermined proportion of active ingredients 2-oxo-1-oxolidine derivatives, plasticizers, stabilizers, flavoring agents and opacifiers into the highly water-soluble film-forming material solution, and stirring for 3 to 8 minutes ; Then high-speed shearing homogenization treatment to obtain a mixed solution; the steps of the high-speed shearing homogenization treatment are: the high-speed shearing speed is set to 5000-20000rpm, and the shearing homogenization time is 3-10min;

[0078] S3, after the mixed solution obtained in s...

Embodiment 1

[0087] An oral instant film preparation containing 2-oxo-1-pyrrolidine derivatives is prepared through the following prescription composition and preparation ratio. (Single dose total weight: 80mg, batch size: 1000 tablets)

[0088] name Dosage (g) Ratio (w / w, %) Bovaracetam 10 12.5 Hydroxypropylmethylcellulose 66.3 82.875 polyethylene glycol 2 2.5 Tea polyphenols 1 1.25 Sucralose 0.2 0.25 Titanium dioxide 0.5 0.625 purified water Add water to 1000mL /

[0089] This preparation method comprises the steps:

[0090] S1, disperse the highly water-soluble film-forming material into water at 85°C, stir and dissolve to obtain a highly water-soluble film-forming material solution, and then cool it to room temperature for later use;

[0091] S2, according to the preparation ratio in the above table, add the active ingredient 2-oxo-1-rolidine derivative, plasticizer polyethylene glycol, stabilizer tea polyphenol, flav...

Embodiment 2

[0094] The oral instant film preparation containing 2-oxo-1-pyrrolidine derivatives is prepared by using the above preparation method through the following preparation ratio. (Single dose total weight: 80mg, batch size: 1000 tablets)

[0095]

[0096]

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Abstract

The invention provides an oral instant film preparation containing a 2-oxo-1-pyrrolidine derivative as well as a preparation method and application thereof. The oral instant film preparation containing the 2-oxo-1-pyrrolidine derivative comprises the following components in percentage by mass: 10%-80% of an active component 2-oxo-1-pyrrolidine derivative, 20%-90% of a high-water-solubility film-forming material, 0.5%-10% of a plasticizer and 0.5%-5% of a mixture formed by mixing a stabilizer, a corrigent and an opacifying agent. The oral instant film preparation has the advantages of good taste, no need of drinking water, high bioavailability and convenience in use, can be quickly dissolved in the oral cavity, and overcomes the technical defect of inconvenience in clinical medication of the existing dosage form. In addition, the production process of the oral instant film preparation provided by the invention is simple, convenient and low in cost, and related pharmaceutic adjuvants are wide in source and easy to purchase, so that the oral instant film preparation has good social benefits and economic benefits.

Description

technical field [0001] The invention relates to the technical field of instant film preparations, in particular to an oral instant film preparation containing 2-oxo-1-pyrrolidine derivatives, a preparation method and application thereof. Background technique [0002] 2-oxo-1-pyrrolidine derivatives, such as buvaracetam, setraracetam, etc., among which buvaracetam significantly improves the antiepileptic activity through the high affinity of SV2A and the inhibition of sodium ion channels, It has good safety and pharmacokinetic properties, especially the good tolerance of the central nervous system, which is obviously superior to other antiepileptic drugs. This product was first approved for marketing by EMA on January 14, 2016, and then approved by FDA on February 18, 2016. The product name is For the treatment of partial-onset epilepsy patients 16 years of age and older, adjuvant therapy with or without secondary generalized seizures. [0003] The invention patent with ap...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/4015A61K47/38A61K47/10A61P25/08
CPCA61K9/7007A61K9/006A61K31/4015A61K47/38A61K47/10A61P25/08
Inventor 金牮胡华胜陈寅郝超张桂森
Owner 武汉久安药物研究院有限公司
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