BIOPHARMACEUTICAL ASPECTS OF DEVELOPMENT OF A NEW MEDICINAL FORM FOR TREATMENT OF ATROPHIC VAGINITIS

DOI: https://doi.org/10.29296/25877313-2019-02-02
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Issue: 
2
Year: 
2019

M.N. Anurova Ph.D. (Pharm.), Sechenov First State Medical University (Moscow) E.O. Bakhrushina Ph.D. (Pharm.), Sechenov First State Medical University (Moscow) E-mail: bachrauschenh@mail.ru A.A. Drygina Student, Sechenov First State Medical University (Moscow) N.B. Demina Dr.Sc. (Pharm.), Sechenov First State Medical University (Moscow) I.I. Krasnyuk Dr.Sc. (Pharm.), Sechenov First State Medical University (Moscow)

The research objective was to evaluate the biopharmaceutical characteristics of the developed complex non-hormonal drug based on sodium hya-luronate and multivitamin complex for the treatment of atrophic vaginitis in the dosage form of a gel. The development of the dosage form was carried out at the Department of the pharmaceutical technology of Sechenov University. Evaluation of the quality of vaginal gel was carried out according to the following characteristics: aggregate stability, pH of water extraction, osmotic and adsorption ac-tivity, rheological characteristics, bioadhesive properties. The developed composition of the vaginal gel for the treatment of atrophic vaginitis was a white homogeneous mass with plasticity, odorless. The composition was aggregately stable during storage in natural conditions for 180 days. the pH of the aqueous extract of 4.2±0.3, the osmotic activity of 155.5±2.8%, the adsorption activity of 0.03±0,0005 g. The study of the rheological characteristics of the gel at temperatures of 20 and 37 showed high thixotropy gel, plastic viscosity and yield stress according to Casson model was 0,161 PA•s and 28.1 PA. The study of bioadhesive carried out by the method of flow compared to the design of vaginal gels have shown the average result among analyzed samples of 5.5 mm/min, which will contribute to the ease of use of the dosage form and the absence of premature evacuation. The developed gel for vaginal use, containing hyaluronic acid, lactic acid and multivitamin complex, ensures the maintenance of the optimal pH of the vagina, has sufficient osmotic and adsorption activity, as well as optimal values of structural, mechanical and bioadhesive properties.

Keywords: 
atrophic vaginitis
vaginal gel
hyaluronic acid
multivitamin complex
non-hormonal therapy

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