Validation of Methods of Identification and Quantitative Determination of Active Ingredients in Films for Treatment of Caries of Dentin

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Introduction. Even though a wide range of the products for caries treatment is available, the efficiency of its treatment with the traditional methods is 62,5–75,4%. As a result of the set of researches carried out at the Department of Pharmaceutical Technology of the Perm State Pharmaceutical Academy, in cooperation with the Department of Dentistry of the Advanced Training and Professional Retraining Faculty of E. A. Wagner Perm State Medical University, a medical method of moderate and advanced caries treatment with remineralizing gel and films is proposed. During the preparation of the product specification file for the dentin caries treatment film, validation of the methods of the active ingredients quality control has been undertaken.Aim. Validation of the methods of identity tests and of potency assays of dentin caries treatment films.Materials and methods. In order to achieve the aim, active pharmaceutical substances of pharmacopoeial quality have been used. As a base for developing the methods of identity tests the methods with distinctive reactions to cations and anions have been taken. For the potency assay of calcium chloride a complexometric back-titration has been used; photoelectric colorimetry for potassium phosphate dibasic and sodium fluoride; spectrophotometry for chlorhexidine bigluconate. Five production samples of the films were the object of the research.Results and discussion. Basing on the research results, the choice was made in favour of the methods of identity tests that are characterized by negative analytical response when applied to the model mixtures which are free from analyte and placebo, and by positive analytical response when applied to the model mixtures of various composition containing analyte. The validation characteristics of the methods of dentin caries treatment films potency assays, which may be included in the product specification file, have been studied.Conclusion. Validation results show that the chosen methods are specific for both identity tests and potency assays of active substances in the dentin caries treatment films; they are characterized by precision, repeatability and linear dependency in the analytical range of ±30% in regard to the specified active substance concentration in the films. All that allows using them for a reliable quality assessment.