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Vonoprazan oral quick-dissolving film agent and method for preparing same

An oral instant film and plasticizer technology, applied in the field of medicine, can solve problems such as difficulty in products, and achieve the effects of improving compliance, solving long disintegration time, and being convenient to carry.

Active Publication Date: 2016-06-15
NANJING GRITPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If the content of these film-forming materials is reduced below 40%, the prepared orally dissolving film preparations will be very poor in toughness, strength, etc., making it difficult to produce, store, transport or clinically take the product

Method used

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  • Vonoprazan oral quick-dissolving film agent and method for preparing same
  • Vonoprazan oral quick-dissolving film agent and method for preparing same
  • Vonoprazan oral quick-dissolving film agent and method for preparing same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Example 1: Preparation of oral instant blank film.

[0042]

[0043] First add the above-mentioned amount of hypromellose, maltodextrin, and hyaluronic acid into pure water under stirring, stir and dissolve to obtain a gel solution, then add glycerin, and stir evenly. Allow the prepared solution to stand or sonicate to remove air bubbles. Spread the solution evenly on 15×15cm 2 Stainless steel plate, 40-60 ℃ blast heating and drying for 2 hours. Remove the film and cut it to get the film agent, which is white in color, easy to remove the film, with average toughness and brittleness.

Embodiment 2

[0044] Example 2: Preparation of oral instant blank film.

[0045]

[0046] First add the above-mentioned amount of hypromellose, maltodextrin, and hyaluronic acid into pure water under stirring, stir and dissolve to obtain a gel solution, then add glycerin, and stir evenly. Allow the prepared solution to stand or sonicate to remove air bubbles. Spread the solution evenly on 15×15cm 2 Stainless steel plate, 40-60 ℃ blast heating and drying for 2 hours. Remove the film and cut it to get the film agent, which is transparent, tough and has good release performance.

Embodiment 3

[0047] Example 3: Preparation of oral instant blank film.

[0048]

[0049] First add the above-mentioned amount of hypromellose, maltodextrin, and hyaluronic acid into purified water under stirring, stir and dissolve to obtain a gel solution, then add glycerin, and stir evenly. Allow the prepared solution to stand or sonicate to remove air bubbles. Spread the solution evenly on 15×15cm 2 The stainless steel plate was heated and dried at 40-60°C for 2 hours. Remove the film and cut it to get the film agent. The film is transparent, has good release performance and is flexible.

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Abstract

The invention discloses a Vonoprazan oral quick-dissolving film agent and a method for preparing the same, and belongs to the field of medicine preparations.The Vonoprazan oral quick-dissolving film agent particularly comprises, by weight, 10-15% of Vonoprazan active monomers, 50-55% of hydroxypropyl methylcellulose, 25-30% of maltodextrin, 0.8-1.0% of hyaluronic acid and 5-10% of plasticizers.The Vonoprazan oral quick-dissolving film agent and the method have the advantages that the water-soluble hydroxypropyl methylcellulose, the water-soluble maltodextrin and the water-soluble hyaluronic acid are preferably used as film-forming materials, the appropriate plasticizers with the appropriate weight ratio are screened, and accordingly the film agent with excellent disintegration time and excellent mechanical performance can be prepared; the disintegration time limit of the Vonoprazan oral quick-dissolving film agent can be obviously shortened, accordingly, the shortcoming that water is required when existing most oral solid preparations are about to be administered can be overcome, the medicine administration time cannot be delayed even under the condition of deficiency of water resources, and the medication compliance of patients can be improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to Vonorazan oral instant film and a preparation method thereof. Background technique [0002] Vonoprazan TAK-438 (Vonoprazan) is a new class of gastric acid secretion inhibitor, its structural formula is as follows: [0003] [0004] Vonoprazan TAK-438 (Vonoprazan) novel potassium channel blockers (P-CABs) for the treatment of non-erosive gastroesophageal reflux disease, duodenal ulcer, gastric ulcer, erosive esophagitis (cured and maintenance therapy). The traditional film-coated tablets currently on the market in Japan have problems such as oral water requirement and low compliance. Therefore, it is necessary to study a dosage form that is convenient for oral administration and quick release. [0005] Oral solid immediate-release preparations include orally disintegrating tablets, sublingual tablets, dispersible tablets and orally dissolving film (RDF). Among t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/4439A61K47/36A61K47/38A61K47/10A61P1/04
CPCA61K9/006A61K9/7007A61K31/4439A61K47/10A61K47/36A61K47/38
Inventor 侯慧刘二军荣嵘霍立茹赵卿李战朱飞
Owner NANJING GRITPHARMA CO LTD
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