Development of Technology and Composition of the Medicinal Product for Oral Cavity Based on Phytosubstances
Authors: Abrosimova O. N. , Pivovarova N. S. , Burakova M. A. , Shebitchenko T. S. 
Published: December 2021

Introduction. Treatment and prevention of diseases of the oral mucosa is one of the priority tasks in dentistry. In practice, antibacterial agents are often used in the complex treatment of inflammatory and destructive processes. However, long-term, uncontrolled usage of such drugs leads to numerous complications: drug tolerance, weakening of the therapeutic effect, dysbiosis of the oral cavity and gastrointestinal tract, etc. Therefore, at present, the question of search for alternative to antibiotic therapy remains open. As an alternative, it is necessary considering the usage of effective and safe herbal medicines that are easy to digest, less toxic, practically do not cause side effects and allergic reactions, and have a light regulating and normalizing effect.

Aim. The aim of the present study is to develop the composition and technology of effervescent granules for the preparation of a solution for rinsing the oral cavity based on phytosubstances.

Materials and methods. Dry extracts were obtained from medicinal plant materials: medicinal sage leaves, medicinal calendula flowers, yarrow herb, medicinal rhizomes and roots and astragalus woolly herb. Sodium carbonate, citric acid, anhydrous, microcrystalline cellulose – 90 (EMCOCEL®90M), povidone (Plasdone™ K-29/32) and calcium stearate were used as auxiliary substances in the granule technology. In laboratory conditions, granules based on phytoextracts were obtained by pressing wet masses. Numerical indicators of medicinal plant raw materials, technological properties of dry extracts and granules, as well as indicators of the quality of granules were determined according to the methods described in the State Pharmacopoeia XIV.

Results and discussion. The numerical indicators of medicinal plant raw materials (grinding of raw materials and the content of impurities, total ash in medicinal plant materials and ash insoluble in hydrochloric acid, humidity, content of extractives) were determined and the good quality of the raw materials used in the subsequent stages of drug development was confirmed. Dry extracts from each type of medicinal plant raw materials have been developed and the technological properties of dry extracts have been determined. The composition and technology of effervescent granules by pressing wet masses has been developed. To improve the flowability and reduce the hygroscopicity of the granulated material, microcrystalline cellulose – 90 (EMCOCEL®90M) was used as a filler. To create an effervescent dosage form, citric acid and sodium bicarbonate were added to the granules. The mass for granulation was moistened with a 10% alcohol-water solution of Plasdone™ K-29/32. A draft specification of quality indicators for effervescent granules based on phytoextracts is proposed.

Conclusion. In the course of the research work, the numerical indicators of medicinal plant raw materials were determined and its quality was confirmed, which made it possible to use it for further production of dry extracts. The extraction conditions were selected for each type of raw material, dry extracts were developed, and quality indicators were determined in accordance with the requirements of the State Pharmacopoeia XIV. Excipients were selected taking into account the properties of dry extracts, the composition and technology of effervescent granules based on phytoextracts was developed, a draft specification for effervescent granules was proposed in accordance with the requirements of the State Pharmacopoeia XIV.