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Sustained-release type orally disintegrating film with excellant oral mucoadhesion and the manufacturing method thereof

A technology of oral disintegration and oral mucosa, which is applied in the directions of medical preparations with non-active ingredients, medical preparations containing active ingredients, and oral care, etc. The effect of increasing the disintegration time

Inactive Publication Date: 2021-02-26
株式会社艾福瑞特
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] Drug delivery technology (DDS) uses nutrients that are easily lacking in the daily diet or raw materials or components that have useful functions for the human body, so it has the advantages of high absorption rate in the body through the oral mucosa and convenience of taking and carrying. It is possible to apply it to the health functional food market beyond the pharmaceutical market, but there is a problem that its applicable fields are extremely limited
[0018] Fifth, because if the active ingredient sticks to the oral mucosa for a long time in the form of a highly concentrated film, water will first be discharged from the mucous membrane in the body by osmotic pressure, and at the same time the thin mucous membrane will lose its elasticity and become wrinkled. If it is effective The ingredients are materials with strong chemical properties, which may cause mucous membrane damage
[0022] On the other hand, recently, while the intake of collagen products is rapidly increasing as a product of the beauty industry group, an oral mucosa absorption type collagen film product is manufactured and sold, and the disintegration time in the oral cavity maintains about 30 to 50-minute slow-release type technology product, but it is not easy to adhere to the mucous membrane and has the inconvenience of being stuck in the tooth or often falling off from the mucous membrane
[0023] This reason is considered to be due to the failure to complete the technology for enhancing the adhesion with the oral mucosa, so it was confirmed that there is no clear solution to these problems so far as a result of searching various prior technologies and papers.
[0024] Also, there arises a problem that a large difference occurs in the dissolution rate through the back side of the attachment surface due to the person who produces a lot of saliva in the oral cavity or the frequent movement and contact of the tongue
[0030] Moreover, Korean Laid-Open Patent No. 10-2019-0032384 (publication date: March 27, 2019) discloses an oromucosa-adhesive material as an oromucosa-adhesive material having a freeze-dried body containing a polymer on the adhesive surface with the oral mucosa. Material, the content of the above-mentioned polymer in the above-mentioned freeze-dried body is 20% by mass or more, and the content of hyaluronic acid in the above-mentioned polymer is 50% by mass or more, but because the adhesion force should be larger as an oral mucosal disease treatment agent characteristics, so as an oral mucosal adhesion improving agent, only the content of hyaluronic acid as a polymer is 10% or more of the total mass as a constituent element, and there is no disclosure of a sustained-release film at all.

Method used

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  • Sustained-release type orally disintegrating film with excellant oral mucoadhesion and the manufacturing method thereof
  • Sustained-release type orally disintegrating film with excellant oral mucoadhesion and the manufacturing method thereof
  • Sustained-release type orally disintegrating film with excellant oral mucoadhesion and the manufacturing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0138] [Step 1: Prepare Materials]

[0139] In addition to the material used in Comparative Example 1, chitosan was used as a positively charged product that was deacetylated with sodium hydroxide in commercially available products, more specifically, as Glycol chitosan (Glycol chitosan, GCS) purchased products from VITATRA (USA).

[0140] [Step 2: Adjust the mixing ratio]

[0141] Using the prepared material, based on pure collagen content 100 mg, the basic composition ratio of the main components affecting the physical properties of a sample product containing chitosan, a film with a final weight of 300 mg, was investigated.

[0142] In Example 1, the same material composition ratio as Comparative Example 1 was used, but the physical property change during drying was first confirmed under the conditions of [Table 6] to find the optimum mixing ratio according to the content of chitosan.

[0143] 【Table 6】

[0144] [Unit: 300mg]

[0145]

[0146] It was shown that in th...

experiment example

[0158] [Sustained release (disintegration) measurement]

[0159] Based on the compositions determined by the above-mentioned Comparative Example 1 and Example 1, 6 samples of Comparative Example and 6 samples of Example were prepared, respectively, and then three samples each of Comparative Example 1 and Example 1 were thinly coated with B Base cellulose (Ethylcellulose), so as to compare the difference in disintegration speed.

[0160] As a matter of course, all samples were prepared in the same process sequence as previously prepared, with the only difference being whether the ethylcellulose was spray coated or not.

[0161] Dissolve ethyl cellulose in purified water at a ratio of 10, put it into a small spray sprayer, spray three times at a distance of about 30 cm from the petri dish, and then completely dry it in a convection oven at 50°C for 30 minutes, so that the final Prepare samples for disintegration testing.

[0162] The device for the disintegration test is confi...

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Abstract

The present invention relates to a sustained-release oral disintegrating film having excellent oral mucosa adhesion, which contains a component with improved oral mucosa adhesion to allow efficient introduction of effective ingredients contained in an oral mucosa film through a capillary inside a mucosal layer since long-term attachment can be performed when being attached to the oral mucosa for use, and a disintegration time can be delayed by oral saliva by increasing adhesion for oral mucosa through a combination of chitosan or a compound thereof and glutathione with respect to components ofan oral mucosa attachable sustained-release oral disintegrating film, and being formed by coating ethyl cellulose exhibiting hydrophobic characteristics on one side of the film, and to a manufacturing method thereof. In addition, the sustained-release oral disintegrating film is purposed for a health functional food or medicine and medical supplies by appropriately mixing and combining effectiveingredients having various functional effects on the basis of film base ingredients secured in the present invention.

Description

technical field [0001] The present invention relates to a sustained-release orally disintegrating film with excellent oral mucosal adhesion and a preparation method thereof, and more specifically, to a composition comprising chitosan or chitosan-modified A sustained-release orally disintegrating film having excellent oral mucosal adhesion, which is a derivative and containing the active ingredient contained in the above-mentioned film, and a production method thereof. Background technique [0002] Many food companies and pharmaceutical companies around the world, including Korea, will continue to introduce nutritional supplements or health functional food products that are inevitably needed in a rapidly aging society through various rapid technological changes. New product. [0003] Based on 2017, the market size of health functional food in Korea is 2,704.7 billion won, indicating that the domestic production is 2,237.4 billion won and the import volume is 575 billion won....

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K38/06A61K38/39A61K47/36A61P17/16A61P17/18
CPCA61K9/7007A61K9/006A61K47/36A61K38/39A61K38/06A61P17/16A61P17/18A61K2300/00A61K47/38A61K38/063A61K47/61A61K8/0204A61K8/736A61K8/64A61Q11/00A61Q19/00
Inventor 李荣睆张泰淳
Owner 株式会社艾福瑞特
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