Combined soft dosage form for local treatment of periodontics

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to pharmaceutics and represents a combined drug preparation for the local treatment of periodontics, including a complex of metronidazole and chlorhexidine in a combination with sodium fusidine, sweetening agents and a pharmaceutically acceptable gel base in the following proportions, g: sodium fusidine 1.8-2.2; metronidazole 0.9-1.1; chlorhexidine bigluconate (in the form of 20% chlorhexidine bigluconate) 0.42-0.58 in the amount equivalent to chlorhexidine 0.08-0.12; sodium saccharinate 0.1-0.3; monoammonium glycerrhizinate (MM100) 0.006-0.008; aerosil 200 (colloidal silicon dioxide) 5.5-6.0; paraffin oil (Vaselin oil) - the rest up to 100 g.

EFFECT: invention provides creating the therapeutic pharmaceutical composition in the form of gel possessing the antibacterial and anti-inflammatory action with an optimum combination of the ingredients to provide a stable depot of the active substances within an area of inflammation for the purpose of treating infectious-inflammatory periodontics of various aetiologies.

3 ex, 1 tbl

 

The invention relates to the field of pharmaceuticals, namely, dental tools topical application for the treatment of infectious-inflammatory diseases of the periodontium, including purulent infections.

Periodontal diseases are extremely widespread among the population. According to the world health organization, the population of middle-aged and older suffer from periodontal disease. The prevalence of this disease among adults remains at a high level and has no tendency to decrease.

The most powerful factor contributing to the development and maintenance of periodontal disease, is the development of dysbiosis in the mouth, which develops on the background of a weakened immune system or cause it to change(Schein W., Meryn S.). This explains the appropriateness of antibacterial agents.

It is well known that chronic periodontitis is a clear shift towards a predominance of anaerobic microflora - inflammation in periodontal pockets number of strains of anaerobic bacteria increases to 70-80%, whereas the average number of anaerobes does not exceed 20-30%. You should assign this local treatment, which would operate in two directions: some measures should be directed at the removal of accumulations of microorganisms, others on the suppression of inflammation is the process. This approach allows you to slow the progression of the disease and accelerate tissue regeneration.

Today the "gold standard" anaerobic means is metronidazole demonstrating high efficacy in inflammatory periodontal disease, especially in combination with chlorhexidine. It should be noted that such a mixture in our country was used for a long time, they were prepared ex tempore, but have disadvantages, such as very bitter taste and lack of precision. However, high efficiency and actual alternatives, provided the sustainable preservation of them team up to present time. Now they are several drugs containing a combination of metronidazole and chlorhexidine: "Metrogyl Denta gel for gums" company unique pharmaceutical, laboratories (India), "MetroPCS" Dr. Reddy with laboratories Ltd (India), "Dentamed" JSC "Altayvitaminy" (Russia). The use of metronidazole as monotherapy in the treatment of periodontal disease is unjustified, as the spectrum of its operations cover about 50-60% of the possible causative agents, a limited range of actions on anaerobes. The concomitant use of metronidazole antibiotic significantly increases the efficiency of antibacterial action (Roche Y, Yoshimori R.N.,1997).

The known method cured the I of periodontal disease pharmaceutical composition of metronidazole connection of several fluoroquinolones (e.g., ofloxacin, ciprofloxacin, norfloxacin) on the basis of glycerokinase (patent # EN 2336877)and glycerole containing solvatochromic of glycerate silicon and titanium (patent # EN 2417102). Fluoroquinolones are broad spectrum of action, but in their application, possible allergic reactions, headaches, sleep disorders, dyspeptic symptoms (nausea, vomiting, diarrhea, heartburn), pain in joints and muscles, leukopenia. During treatment with fluoroquinolones should be avoided ultraviolet irradiation because of possible photosensitivity of the skin. All the fluoroquinolones are contraindicated in children (under 15 years) with incomplete growth of the skeleton.

Also known gel composition Guidant" containing the sodium salt of hyaluronic acid (tissue repair stimulator) and the complex with metronidazole chlorhexidine is an antimicrobial agent with antibacterially and antiseptic effect against anaerobic bacteria and protozoa (patent # EN 2286764).

In 39.5% of cases, the causative agents of purulent-inflammatory diseases of maxillofacial area are staphylococci. Against the background of continuous use of medicinal preparations containing antibiotics, the risk of emergence of resistant forms of pathogenic microorganisms, and also increases the likelihood of development of a dysbacteriosis of the oral cavity. It is established that aleccia resistant strains occurs in particular, when there are sharp differences of concentration of drugs. It is observed in the local application of various antibacterial agents (in the form of mouthwashes, toothpastes and gels, easily washed away by saliva), as the mucosa has a strong buffer system and in the result, the efficiency of penetration through the mucosa of the gums components of the medicinal product is not the same.

At the present time for the preparation of soft medicinal forms use different ointment and gel bases: lipophilic, hydrophilic, combined, each of which has its advantages and disadvantages. However, given the characteristics of dental practice, the most promising dosage form gels are easily dosed and with sufficient fluidity to fill paracetalmol pocket. The main problem of local applications is the difficulty of creating an effective concentration in the whole volume of periodontal lesions and maintaining it within a reasonable treatment time. The adhesion of the drug and, consequently, the creation of sustainable depot of active components in the area of inflammation creates favorable conditions for the effective treatment and subsequent prevention of periodontal diseases.

The present invention is the creation of medicines Pharm is cautiously composition in gel form, possessing antibacterial and anti-inflammatory action, with an optimal combination of components that provide sustainable depot of active substances in the area of inflammation for the integrated treatment of infectious and inflammatory periodontal diseases of different etiology.

The problem is solved in that the proposed product contains the complex metronidazole and chlorhexidine in combination with antibiotic - fuzidinu sodium, sweeteners and as a carrier contains oily gel base, which is a mixture of paraffin oil or liquid paraffin) and colloidal silicon dioxide (Aerosil 200) in the following ratio of components, g:

tr>
Fuzidin sodium crystalline1,8-2,2
Metronidazole0,9-1,1
Chlorhexidine digluconate (a 20% solution of chlorhexidine digluconate)0,42-0,58
in the amount equivalent to chlorhexidine0,08-0,12
Sodium saccharinateof 0.1-0.3
Glycerinate of monoamine (100 MM)0,006-0,008
Aerosil 200 (colloidal silicon dioxide)5,5-6,0
The liquid paraffin (vaseline oil)the rest is up to 100 g

These ranges of concentrations of active substances are optimally acceptable and pharmacologically significant.

The proposed framework is a transparent gel with a pseudoplastic-type properties. Distinctive features of this gel are improved distribution of the active substances in the whole volume of the preparation, good thermal and microbiological stability and ensuring the adhesion of the drug in the area of inflammation due to the high sorption properties of Aerosil.

The choice of antimicrobial active ingredients based on inhibition of a wide range of pathogenic microorganisms, including aerobic gram-positive bacteria, aerobic gram-negative bacteria, anaerobic bacteria (spore - and nesporoobrazuth), protozoa. Preference is given to the use of combined drugs with regard to their more balanced effect on the mucous membranes.

Metronidazole - derived intorimidazole with Antiprotozoal and antibacterial activity against anaerobic bacteria and protozoa that cause periodontal: Porphyromonas gngivalis, Prevotella intermedia, P. Denticola, Fusobacterium fusiformis, Wolinella recta, Treponema sp., Eikenella corrodens, Borrelia vincenti, Bacteroides melaninogenicus, Selenomonas sp. concentration of metronidazole required to suppress 50% of strains (MIC) below 1 µg/ml for anaerobic bacteria that cause periodontal disease. Penetrates well into tissues and organs. Metronidazole can be combined with antibiotics and antiseptics. The local application the concentration of metronidazole in the gums is much higher than the oral application, therefore, the reduction ratio of the drug minimizes the potential risk of systemic side effects.

Chlorhexidine acts in two stages, providing antiseptic effect. The initial stage is a bactericidal action on Gram-positive and gram-negative bacteria. The next stage is more significant long-term bacteriostatic effect, resulting in adsorption of the drug on the surface of the teeth and the mucous membranes of the oral cavity. Based on the results of clinical practice, medical devices, contain chlorhexidine, today is considered the most active antibacterial agents for local use.

Fuzidin sodium is an effective antibiotic that slows the growth and development of microorganisms. the persistent to other antibiotics. Shows high specific antimicrobial activity against staphylococci, meningococci, gonococci, Most activity fuzidin sodium has against Staphylococcua aureus and Staphylococcus epidermidis (including methicillin-resistant and methicillin-sensitive strains), Clostridium spp., Peptostreptococcus spp. well absorbed, has the ability to penetrate and accumulate in the bone tissue, which increases its clinical value in the treatment of purulent-inflammatory diseases of the bones caused by staphylococci resistant to other antibiotics, when abstemiously forms of periodontitis. The combination of fuzidinu with other antibiotics potentiates the antibacterial effectsplease crystalline substance of fuzidinu sodium (with a particle size less than 20 microns) increases the bioavailability of the pharmaceutical compositions according to this invention.

As fuzidin sodium has a rather unpleasant taste, it is an important factor in the development of the dental composition of the gel is to disguise the taste. As mascerator taste in the pharmaceutical compositions according to this invention uses a combination of saharinata sodium and glycerinate of monoamine (100 MM). The sodium saccharinate allows you to mask the bitter taste of fuzidinu at the initial stage of use of the drug. Organoleptically action MM 100 also decided the Leno unusual dynamics taste effects in time - delayed manifestation and prolonged nature of the action 100 MM allows to enhance the sweet taste of saharinata, to minimize or completely eliminate the bitterness suppressing residual taste.

Example 1.

5.5 g of Aerosil 200 is mixed with the calculated quantity of paraffin oil until smooth (mixture 1). 1.8 g of fuzidinu sodium is mixed with a mixture of 1 part at a ratio of 1:3, homogenize to obtain the mass of the corresponding particle size (mixture 2). 0.9 g of metronidazole mixed with a mixture of 1 part at a ratio of 1:3, add 0.3 g of saharinata sodium, add 0,006 g M, mix, homogenize to obtain the mass of the corresponding particle size (mixture 3). A mixture of 1, 2, 3 combine, add 0,425 g of chlorhexidine digluconate, mix until smooth, Packed in tubes.

Example 2.

The estimated amount of mineral oil is heated to 40°C, add 6.0 g of Aerosil 200 pereshivayut until homogeneous, cooled to 35°C (mixture 1). 2 g of fuzidinu sodium is mixed with a mixture of 1 part at a ratio of 1:3, homogenize to obtain the mass of the corresponding particle size (mixture 2). 1.0 g of metronidazole mixed with a mixture of 1 part at a ratio of 1:3, add 0.2 g of saharinata sodium, add 0.0075 g 100 MM, mix, homogenize to obtain the mass of the corresponding particle size (mixture 3). A mixture of 1, 2, 3 combine, add 0.5 to the solution of chlorhexidine digluconate, mix until smooth, Packed in tubes.

Example 3.

The estimated amount of the paraffin oil (in a ratio of 3:1 from the number of metronidazole) is heated to 40°C, add 1.1 g of metronidazole, 0.1 g of saharinata sodium, 0.008 g MM, mixed and homogenized to obtain the mass of the corresponding particle size, cooled to 30-35°C (mixture 1).

The estimated amount of the paraffin oil (in a ratio of 3:1 from the number of fuzidinu sodium) is heated to 40°C, add with stirring, 2.2 g of fuzidinu sodium, homogenize to obtain the mass of the corresponding particle size (mixture 2).

The remaining amount of mineral oil is heated to 40°C, add Aerosil 200 pereshivayut until homogeneous, cooled to 30-35°C (mixture 3).

A mixture of 1, 2, 3 unite under stirring, add 0,575 g of chlorhexidine digluconate, homogenized, Packed in tubes.

Received the drug is stable during storage, meets the requirements of Pharmacopoeia and has a shelf life of 2 years (table 1).

Sources of information

1. Patent RU 2336877.

2. Patent RU 2417102.

3. Patent RU 2286864.

4. Grudanov A.I., Elderly N.A., Medicines used in periodontal diseases, Periodontics, №2(8), 1998.

5. Tsarev NR. et al. The choice antibacterially preparations for the integrated treatment of periodontitis in the stage on which ostrinia, Stomatologija, T, No. 6, 1997.

6. On The Main Page. Drugs in Russia: a Handbook. M: Attraversare, 2001.

7. Vihrova NM Petrova M.A., Fomin I.P., Navashin S.M., Fuzidin and its properties, Antibiotics, 1967.

8. The state register of medicines, http://grls.rosminzdrav.ru

Table 1
Table of analytical data on the quality and stability of the medicinal product
DescriptionMicrobiological purityParticle sizepHQuantitative determination
The gel is white with a yellowish sheen color<10/<10/UTS.Not more than 90 μmfrom 6.0 to 8.0fuzidin sodium from 1.8 to 2.2%metronidazole from 0.8 to 1.2%chlorhexidine from 0.08 to 0.12%
at the time of manufacture
App.1Respectively.Respectively. to 83.56,71,840,920,087
PRRespectively.Respectively.82,96,82,041,02is 0.102
PRRespectively.Respectively.82,76,52,221,080,113
after 2 years of storage at the end of the shelf life
App.1Respectively.Respectively.82,86,61,820,910,085
PRRespectively.Respectively.82,66,72,001,01is 0.102
PRRespectively. Respectively.83,36,7of 2.211,100,115

Drug combined action for local treatment of periodontal disease, including complex metronidazole and chlorhexidine in combination with fuzidinu sodium, sweeteners and pharmaceutically acceptable gel-based, in the following ratio of components, g:

Fuzidin sodium1,8-2,2
Metronidazole0,9-1,1
Chlorhexidine digluconate (a 20%solution of chlorhexidine digluconate)0,42-0,58
in the amount equivalent to chlorhexidine0,08-0,12
Sodium saccharinateof 0.1-0.3
Glycerinate of monoamine (MM)0,006-0,008
Aerosil 200 (colloidal silicon dioxide)5,5-6,0
The liquid paraffin (vaseline oil)the rest is up to 100



 

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