Research on the Creation of Dental Gel with Acyzol

Golovanenko, A. L.; I.V., Alekseeva; Berezina, E. S.; Flisyuk, E. V.; Nogaeva, U. V.; Titovich, I. A.

doi:10.33380/2305-2066-2022-11-4-194-200

Cited by 3 publications

(3 citation statements)

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“…Для определения количественного содержания натрия фторида использовали фотоэлектроколориметрический метод (фотометр КФК-3, АО «ЗОМЗ», Россия), с применением реакции с цирконий-ализариновым комплексом, расчет проводили по рабочему стандартному образцу 2 .…”

Section: методыunclassified

“…Характерные свойства гелей -одновременно твердого тела и жидкости -делают их одними из самых современных средств в практической медицине. Гели имеют простую технологию и комфортны в применении [1][2][3][4][5][6][7][8][9][10][11]. Стоматологические гели как твердое тело обладают способностью задерживаться на зубах, и как жидкость гели эффективны при аппликационном воздействии.…”

Section: Introductionunclassified

“…Для подтверждения подлинности и количественного определения действующих веществ (ДВ) использовались химические и физико-химические методы, модифи-цированные с учетом особенностей лекарственной формы (ЛФ) 1 . Валидация аналитических методик проводилась в соответствии c OФC.1.1.0012 «Валидация аналитических методик» 2 .…”

Section: Introductionunclassified

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Validation of Analytical Methods for Quality Control of Gel for Dentin Remineralization

Golovanenko,

Berezina,

Alekseeva

et al. 2023

Razrabotka i registraciâ lekarstvennyh sredstv

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Introduction. As a result of a complex of scientific and experimental studies carried out at the Department of Pharmaceutical Technology of the State Pharmacy of Pharmaceuticals, a gel was developed for remineralization of dentin in order to carry out drug treatment of medium and deep caries. In the developed gel, along with the remineralizing effect, an antibacterial effect was achieved, which is necessary in the treatment of dentin caries due to the introduction of chlorhexidine bigluconate (CHB). The proposed composition simultaneously contains the main remineralizing ions – calcium, phosphate and fluoride in a free active state. Due to this, a significant increase in their penetration into the dentin is ensured. During the preparation of regulatory documentation for the gel for the treatment of dentine caries, validation of methods designed to control the quality of active substances was carried out.Aim. Validation of methods for testing the authenticity and quantification of active substances in the gel for dentine remineralization.Materials and methods. To achieve this goal, active pharmaceutical substances of pharmacopoeial quality are used. When developing test methods, pharmacopoeial and non-pharmacopoeial reactions to reacting cations and anions were used. For the quantitative determination of the chloride compound, the complexometric method, the back titration method is used, for potassium phosphate, the disubstituted acidimetric method, for sodium fluoride, the photoelectrocolorimetric method, for chlorhexidine bigluconate, the lauryl sulfate method. The objects of study were five serial samples of gels.Results and discussion. As a result of the studies, methods of testing for authenticity were developed, it was found that the proposed methods are characterized by a negative analytical signal on model mixtures free of the analyte and placebo, and a positive analytical signal on model mixtures of various compositions containing the analyte. The validation characteristics of methods for the quantitative determination of active substances in the gel were studied, positive results were obtained, the proposed methods can be used for inclusion in the regulatory documentation for the developed gel.Conclusion. When evaluating the validation characteristics of the proposed methods, it was found that the methods of testing for authenticity and quantitative determination of active substances in the gel are specific, the methods of quantitative determination are characterized by accuracy and repeatability, a linear dependence in the analytical region of ±20 % of the declared amount of active substances, which allows them to be used for reliable assessment of the quality of the developed gel.

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Section: методыunclassified

Section: Introductionunclassified

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Validation of Analytical Methods for Quality Control of Gel for Dentin Remineralization

Golovanenko,

Berezina,

Alekseeva

et al. 2023

Razrabotka i registraciâ lekarstvennyh sredstv

Self Cite

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Modern methods and materials used to treat root perforation: effectiveness comparison

Ma,

Xu,

Chen

et al. 2024

J Mater Sci: Mater Med

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This study aims to experimentally compare the efficacy of different endodontic materials (iRoot BP Plus, Biodentine, MTA, Rootdent, and Trioxide) in the treatment of pulpitis and perforations on extracted tooth specimens. Additionally, the study aims to investigate the influence of iRoot BP Plus endodontic material on the regenerative processes following pulp amputation in laboratory animals. The secondary goal is to evaluate the effect of iRoot BP Plus on the restoration process in laboratory animals after pulp removal. The study presents a micropermeability analysis of the selected biomaterials performed on a sample of 50 single-rooted apical teeth in 2022. All teeth underwent endodontic treatment. Changes in molar morphology were investigated with eight laboratory animals (rabbits, 3 months old, all males) after simulated pulp removal and subsequent treatment with the iRoot BP Plus biomaterials. iRoot BP Plus appeared to be more effective in retrograde apical root filling than other biomaterials, as evidenced by its higher sealing effect. An experiment involving animal participants revealed the presence of protective adaptive mechanisms, which manifested in the form of an inflammatory process within 6 weeks after the dental pulp was removed. The connective tissue replaced the necrosis, and new capillaries began to form intensively. These dental outcomes suggest that iRoot BP Plus enables hermetical sealing in tooth restoration with good adhesion. Thus, it may have the ability to promote more active tissue regeneration after pulp removal. Graphical Abstract

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Studying the Validation Characteristics of Testing Methods for Authenticity and Quantitating Determination of Acysole in Dental Gel

A.L.,

E.S.,

I.V.

et al. 2024

Mediko-farmacevtičeskij žurnal "Pulʹs"

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In the quality assurance system for medicinal products, an important role is played by the procedure for validation of analytical methods at the stages of development, testing, technology and serial production. The need for validation at the stage of drug development is due to the fact that it is possible to promptly identify the shortcomings of the method and significantly improve it. The purpose of this study is to validate methods for testing «The authenticity» and «Quantitative determination» of acyzole in dental gel. Materials and methods. To achieve this goal, an active pharmaceutical substance of pharmacopoeial quality was used. When developing methods for testing for “Authenticity,” a reaction with oxalic acid to the zinc cation determined in the composition of acyzole was used. For the quantitative determination of acyzole, the complexometric method was used. The objects of the study were three series of gel samples. Results and discussion. As a result of the research, a method for testing «Authenticity» was developed; it was found that the proposed method is characterized by a negative analytical signal on model mixtures free of the analyte component and placebo, and a positive analytical signal on model mixtures of various compositions containing the analyte component. The validation characteristics of methods for the quantitative determination of acyzole in the gel were studied. positive results were obtained. The proposed methods can be used for inclusion in the regulatory documentation for the developed gel. Conclusion. When assessing the validation characteristics of the proposed methods, it was established that the methods for testing the «Authenticity» and «Quantitative determination» of acyzole in the gel are specific, the methods of quantitative determination are characterized by accuracy and repeatability, a linear dependence in the analytical range of ±20% of the declared amount of acyzole, which allows them to be used for a reliable assessment quality of the developed dental gel.

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Research on the Creation of Dental Gel with Acyzol

Cited by 3 publications

References 1 publication

Validation of Analytical Methods for Quality Control of Gel for Dentin Remineralization

Validation of Analytical Methods for Quality Control of Gel for Dentin Remineralization

Modern methods and materials used to treat root perforation: effectiveness comparison

Studying the Validation Characteristics of Testing Methods for Authenticity and Quantitating Determination of Acysole in Dental Gel

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