ANALYSIS OF OROMUCOSAL MEDICINAL PRODUCTS IN SOLID DOSAGE FORMS FOR THERAPEUTIC DENTISTRY

In order to determine the necessity of creating dental medicinal products the oromucosal dosage forms of the Ukrainian pharmaceutical market have been analysed. Tablet drugs are increasingly used in the treatment of periodontal diseases. Based on the results of the analysis of 35 drugs it has been found that the share of drugs produced in Ukraine (23%) ranks second after Germany (31%) among manufacturer countries. According to the data of the marketing research 54.3% of solid dosage forms are tablets, 25.7% – lozenges and 20% – pastilles. It has been determined that 34.3% of drugs are two-component products, 25.7% – three-component, 20% are one-component and 20% are multi-component. Distinguishing the concept of active substances it has been shown that 77.1% of drugs contain antiseptics, 14.3% – antibiotics, 20% – essential oils, 17.1% – anesthetics. Natural substances as a component are in 8.6% of medicinal products, e.g. phenolic hydrophobic propolis preparation in “Proalor” (LLC “Pharmaceutical company “Zdorovie”, Ukraine), a thick sage extract in “Shavlia” (Natur Product Europa BV, Netherlands) and a solid chlorophyllipt extract in “Chlorophyllipt” tablets (LLC “Pilot Plant “State Scientific Centre on Medicinal Products”, Ukraine). It has been found that there is dominance of combined drugs and a small share of drugs based on natural substances; therefore, creation of oromucosal herbal medicinal products in a solid dosage form is expedient.

One of the most pressing problems in Ukraine is the health status of the population, including such component as dental health, which low level has a negative impact on the general health condition during all periods of life [4]. Dental service is growing rapidly in Ukraine. Physicians prescribe drugs to patients in different dosage forms for therapeutic purposes [5]. Scientific works of domestic and foreign researchers focus on pharmacotherapeutic issues of oral inflammatory diseases outlining the ways to create new drugs for dental practice, defining the prospects for new research based on the assessment of the range of dental drugs at the Ukrainian pharmaceutical market, etc. [6,8,11].
Pharmacotherapy of inflammatory periodontal diseases increasingly offers solid dosage forms, such as orally disintegrating (mouth dissolving) tablets, sublingual tablets, lozenges or pastilles that are easy to administer and have pleasant organoleptic properties for a patient [7,14]. Each of these solid dosage forms has its own specific characteristics. This is primarily due to the advantages in use, dosage of this form, the absence of difficulties with swallowing or discomfort of passage through the gastrointestinal tract, the possibility of combining several active substances with addition of flavouring agents to enhance organoleptic properties, and it is achieved by the technology of manufacturing the abovementioned medicinal form [3]. Oral pills are usually represented by uncoated tablets with the composition providing slow release and the local action of the active substance or substances, or release and absorption of the active substance or substances in certain parts of the mouth [9, 12, 13]. Lozenges and pastilles are solid single-dose drugs dissolving in the mouth for the local effect, containing one or more active ingredients; they are usually aromatic or sweet-based. They are prescribed for slow dissolution or dispersion in the oral cavity as a result of disintegration, i.e. they are at the site of inflammation for a long period of time, and it allows prolonging the local exposure of active substances [1].
The aim of the research is to carry out the comprehensive assessment of the range of solid drugs used in dental practice in treating diseases of the oral cavity and to determine the expedience of developing new dental products of this dosage form.

Materials and Methods
The study involved medicinal products for dental practice of the following groups according to the ATC classification [1]: A A01 -Stomatological preparations (A01A B53 -Chlorhexidine, combinations; A01A D -Other agents for Using the concentric method the information search was conducted, and 35 drugs labeled for "inflammation of gums and oral mucosa, periodontitis, stomatitis, gingivitis" in the solid dosage form were analysed [2].

Results and Discussion
A detailed analysis of drug manufacturers has shown that Ukraine as a supplier of medicinal products for dental practice ranks second after Germany since the number of solid dosage forms produced by this country amounts for almost one third (31%) of the total amount. The rest of drugs are supplied by such manufacturer countries as Slovenia, Russia, Poland, Netherlands, France and Bosnia and Herzegovina. It is shown in Fig. 1. Fig. 2 shows distribution of solid drugs in therapeutic dentistry. It has been determined that among the medicinal products studied pills (including orally disintegrating tablets, oral tablets) are 54.3%, lozenges -25.7% and pastilles -20%.
A separate study was performed to assess the amount of active drug substances: 34.3% of the segment under research belonged to two-component drugs, 25.7% -threecomponent, 20% -one-component and 20% -multi-component. Most of the drugs are combined (Fig. 3). They comprise several antimicrobial components with different mechanisms of action and include the following combinations: antiseptic + vitamin, antiseptic + anesthetic, antiseptic + vitamin + anesthetic, antibacterial component + antiseptic, antiseptic + essential oils, antiseptic + extracts of medicinal plants, products of the natural origin + vitamin.   Such combinations allow obtaining the desired therapeutic effect. Addition of various components of essential oils (menthol, anethole, thymol, etc.) to the antimicrobial component gives a mild local anaesthetic effect, while essential oils or extracts of medicinal plants (peppermint, sage, eucalyptus) enhance the antimicrobial and anti-inflammatory effect.
Medicinal products with a strong anesthetic action contain local anesthetics (benzocaine hydrochloride, lidocaine hydrochloride, oxybuprocaine chloride, etc.). Drugs for ulcerative necrotic lesions of the oral mucosa are found to contain enzyme components, such as lysozyme hydrochloride with antibacterial properties and ability to stimulate the body's non-specific reactivity by splitting necrotic tissues.
Natural substances as a component are in 8.6% of medicinal products, e.g. phenolic hydrophobic propolis preparation in "Proalor" (LLC "Pharmaceutical company "Zdorovie", Ukraine), a thick sage extract in "Shavlia" (Natur Product Europa BV, Netherlands) and a solid chlorophyllipt extract in "Chlorophyllipt" tablets (LLC "Pilot Plant "State Scientific Centre on Medicinal Products", Ukraine).
The anesthetic component (active substances -benzocaine, oxybuprocaine chloride, tetracaine hydrochloride, lidocaine hydrochloride) are in 17.1% of the drugs under study (Septolete® Plus Menthol, Septolete® Plus Honey and Lime (KRKA, Slovenia) Anti-Angin Formula (HERKEL BV, Netherlands), Grammidin® with anesthetic Neo (JSC "Valenta Pharmaceuticals", Russian Federation) Trachisan (Engelhard Arzneimittel GmbH & Co.KG, Germany), Dorithricin (RIEMSER Specialty Production GmbH, Germany)). CONCLUSIONS The range of solid medicinal products that are available at the domestic pharmaceutical market and used in dental practice in the treatment of inflammatory periodontal disorders and oral diseases has been analysed.
Medicinal products have been characterized depending on the manufacturer country, the type of a solid dosage form and structured according to the amount and content of active components and their combination.
It has been found that the segment of natural oromucosal drugs for therapeutic dentistry is too small.
It has been determined that creation of a new oromucosal herbal medicinal product in a solid dosage form is based on natural substances can be considered to be a relevant and up-to-date task for pharmaceutical technology.