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Mouth mucosa sustained-release preparation for treating oral and periodontal diseases by chlorhexidine

A technology for oral periodontal disease and oral mucosa, which is applied in the field of medicines for treating oral mucosal diseases and the preparation thereof, can solve the problems of short drug release time, loss of treatment effect of oral patients, etc., and achieves long drug release time and convenient application. , The effect of uniform release speed

Inactive Publication Date: 2013-05-22
上海微丸医药开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The first is that the drug release time is still too short. Only a limited part of the drug ingredients in the lozenge can penetrate into the submucosa through the contact between saliva and mucous membranes, while most of the drugs enter the stomach with the swallowing of saliva, and are basically lost. Therapeutic Effects on Oral Diseases
Second, simply increasing the dose can lead to an unacceptably strong bitter taste of antibiotics
[0009] But so far, there has been no relevant report on the application of non-adhesive low-water-soluble materials to oral mucosa sustained-release tablets to prepare an adhesive system with quick-acting adhesion and long-term drug release.

Method used

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  • Mouth mucosa sustained-release preparation for treating oral and periodontal diseases by chlorhexidine
  • Mouth mucosa sustained-release preparation for treating oral and periodontal diseases by chlorhexidine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Pharmaceutical active adhesive layer (a) raw material:

[0042] Adhesive: 8.0 grams of polyvinylpyrrolidone, 8.0 grams of polyoxyethylene;

[0043] Disintegrant: microcrystalline cellulose 10.0 g;

[0044] Flavoring agent: menthol 1.5g;

[0045] Antibiotics: minocycline 2.5 grams;

[0046] Raw material of non-adhesive layer (b): composed of polyvinyl alcohol (alcoholysis degree 92%).

[0047] Preparation of Oral Mucosal Drug Sustained Release Patch:

[0048] A flat-bottomed mold with a diameter of 5 mm is used to prepare the tablet by direct compression, and the dried powder of the above-mentioned excipients and the dry powder of the active drug are uniformly mixed according to the formula ratio, and a flat cylinder is obtained under the direct compression condition of 1000 kg of pressure and 6 seconds. Shaped patch, the thickness of the patch is 0.8-1.2 mm, and the weight of the patch is 25.0-32.0 mg;

[0049] Prepare polyvinyl alcohol into a 10% aqueous solution ...

Embodiment 1-1

[0052] Example 1-1: Single-sided sealing film patch experiment

[0053] The sample diameter is 5.0 mm, the thickness is 1.2 mm, and the weight is 30 mg

[0054] figure 1 Series 1 shows the results of the dissolution test for this patch. It can be seen that the solid concentration in the dissolution medium increases steadily over time, and its sustained release time can reach 8 hours. The drug release amount in the early stage is equal, and the drug release amount between 3 hours and 7 hours is enlarged. In 7-8 hours, the drug ingredients in the patch are almost released, and the drug release rate is equivalent to that of the previous period, and the disintegration process of the entire drug patch is relatively stable.

Embodiment 1-2

[0055] Example 1-2: Overall coating comparison sheet experiment

[0056] The sample piece has a diameter of 5.0 mm, a thickness of 1.2 mm, and a weight of 30 mg.

[0057] figure 1Series 2 shows the results of the dissolution test for this patch. It can be seen that there is basically no substance dissolved in the patch in the first 5-6 hours, the dissolved amount increases significantly in 7 hours, and basically completely dissolves in 15 hours.

[0058] The above experimental results show that the polyethylene coating coated on the patch has an obvious restrictive effect on the dissolution of the adhesive.

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Abstract

The invention relates to fields of a drug for treating a disease of cari oris mucosa, and preparation thereof, and particularly relates to a mouth mucosa sustained-release preparation for treating oral and periodontal diseases by chlorhexidine. The preparation is composed of a mouth mucosa contact layer and a non-adhesive seal layer; the mouth mucosa contact layer comprises the components of an antibiotic drug and an auxiliary material, of which the weight ratio is (2-20) to (80-98); the non-adhesive seal layer comprises the components of a non-adhesive low-water soluble high-molecular polymer; the non-adhesive low-water soluble high-molecular polymer is selected from polyving akohol; the mouth mucosa sustained-release preparation comprises the components of 4.0g of chlorhexidine, 12.0g of hydroxyethyl cellulose, 5.5g of modified starch, 7.0g of microcrystalline cellulose, 0.5g of grape essence and the balance of polyving akohol. The mouth mucosa sustained-release preparation has the advantages of being convenient to drug delivery, long in drug release time, even in drug release speed, strong in target, strong in mucosa adhesive force and the like; and the preparation method is simple to operate, low in cost, friendly to environment, and suitable for industrial production.

Description

technical field [0001] The invention belongs to the field of drugs for treating oral mucosal diseases and the preparation thereof, in particular to an oral mucosa drug slow-release preparation for treating oral periodontal diseases with chlorhexidine. Background technique [0002] Periodontal diseases such as periodontitis are relatively common oral diseases. Even in developed countries, the incidence rate of adults can reach more than 50%. It is more serious in areas with poor medical conditions, and can be as high as 90%. There are many causes of periodontal disease, and its formation mechanism is complex. Periodontal diseases such as periodontitis are generally believed to be infectious diseases caused by specific forms of bacteria in dental plaque. Plaque microorganisms and their products act on the gums for a long time, causing the body's immune response, first leading to an inflammatory response of the gums. When suffering from gingivitis, the inflammation is limite...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K45/00A61K31/155A61K31/65A61K31/4164A61K47/32A61K47/38A61P1/02A61P31/02
Inventor 蒋健庆
Owner 上海微丸医药开发有限公司
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