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Mouth mucosa drug sustained release preparation for treating mouth periodontal disease by doxycycline

A technology for oral periodontal disease and oral mucosa, which is applied in the field of drugs for the treatment of oral mucosal diseases and its preparation, can solve the problems of short drug release time and loss of therapeutic effect of oral diseases, and achieve long drug release time and convenient drug application , low cost effect

Inactive Publication Date: 2015-06-10
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 drug sustained release preparation for treating mouth periodontal disease by doxycycline
  • Mouth mucosa drug sustained release preparation for treating mouth periodontal disease by doxycycline

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 (Series 1) shows the results of the dissolution test of the 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 (Series 2) shows the results of the dissolution test of the 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 drugs for treating mouth mucosa diseases and the manufacture field of the drugs for treating mouth mucosa diseases, in particular to a mouth mucosa drug sustained release preparation for treating a mouth periodontal disease by doxycycline. The preparation is composed of a mouth mucosa contacted layer and a non-adhesiveness sealing layer. The mouth mucosa contacted layer comprises, by weight, 2-20 / 80-98 of antibiotic drugs and auxiliary materials. The components of the non-adhesiveness sealing layer are non-adhesiveness low water-solubility high-molecular polymers. The non-adhesiveness low water-solubility high-molecular polymers are chosen from polyvinyl alcohol. The components of mouth mucosa drug sustained release preparation comprise 2.0g of methyl vinyl ether-maleic anhydride copolymers, 2.0g of polyoxyethylene, 2.0g of carboxymethyl cellulose sodium, 12.0g of natural starch, 2.0g of menthol and 0.5g of doxycycline, and the rest is poval. The mouth mucosa drug sustained release preparation has the advantages that drug delivering is convenient, drug releasing time is long, drug releasing speed is even, targeting is strong, and adhesive force with mucosas is strong. In addition, the manufacturing method is simple in operation, low in cost, environment-friendly 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 doxycycline. 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 limited ...

Claims

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Application Information

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