Pharmaceutical development for phleboprotective and anti-inflammatory gels: analytical support of the technological process

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Abstract

External soft dosage forms with a penetrating effect of different efficacy have proved promising in the treatment of inflammatory diseases. Moreover, there are few such medicines on the modern pharmaceutical market, and replenishment of their assortment is relevant.

Objective. The purpose of these studies is to develop external soft dosage forms for various purposes using penetrators, their technological features and analysis.

Material and methods. The work used: purified micronized flavonoid fraction (diosmin+flavonoids in terms of hesperidin), which has a phleboprotective effect; Tizol – aquacomplex of titanium glycerosolvate is a metal complex compound with anti-inflammatory and antimicrobial action; L-arginine is an essential amino acid, a nitrogen donor; auxiliary substances: Polyethylene Oxide 400, Polyethylene Oxide 1500, Propylene Glycol-1,2. The studies were carried out using spectrophotometric determination, biopharmaceutical determination of a penetrator in a dental gel.

Results. Optimal compositions of ointment and gel were developed, a general technological scheme of production was designed. Based on the analysis of the technological scheme, we recorded the critical stages of the process common to both objects. As for the methods for the quantitative analysis of ointment with a flavonoid complex, they are validated. Studies on the microbiological purity of dental gel allowed us to make an unambiguous conclusion about the sterility of the gel. This, in turn, ensures the effectiveness of therapy with such a drug, due to the absence of side microbiological contamination during use, as well as the absence of the risk of concomitant diseases.

Conclusion. As a result of the conducted research, compositions of external soft dosage forms of phleboprotective and dental profile containing penetrating components were developed.

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About the authors

V. K. Maltseva

Pyatigorsk Medical and Pharmaceutical Institute – branch of the Volga State Medical University of the Ministry of Health of Russia

Author for correspondence.
Email: maltsev.tom@mail.ru

Post-graduate Student, Department of Pharmaceutical Technology with a Course in Medical Biotechnology

Russian Federation, Pyatigorsk

E. A. Samoshina

Pyatigorsk Medical and Pharmaceutical Institute – branch of the Volga State Medical University of the Ministry of Health of Russia

Email: Ekaterina_samosh@mail.ru

Senior Lecturer, Department of Pharmaceutical Technology with a Course in Medical Biotechnology

Russian Federation, Pyatigorsk

M. S. Makieva

North Ossetian State University named after K.L. Khetagurov

Email: makieva-marina@yandex.ru

Ph.D. (Pharm.), Associate Professor, Department of Pharmacy

Russian Federation, Vladikavkaz

E. F. Stepanova

Pyatigorsk Medical and Pharmaceutical Institute – branch of the Volga State Medical University of the Ministry of Health of Russia

Email: efstepanova@yandex.ru

Dr.Sc. (Pharm.), Professor, Department of Pharmaceutical Technology with a Course in Medical Biotechnology

Russian Federation, Pyatigorsk

References

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Supplementary files

Supplementary Files
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1. JATS XML
2. Figure 1. Dependence of the degree of release of the area of thysol on its concentration in the studied samples

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3. Figure 2. Influence of penetrators on the degree of release of active substances from the developed phleboprotective gel

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4. Figure 3. Influence of propylene glycol concentration on the degree of release of active substances from the developed phleboprotective gel

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5. Figure 4. Absorption spectra: a – dialysate sample; b – SS of diosmin; c – placebo solution sample

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6. Figure 5. Calibration curve for the dependence of optical density on the concentration of diosmin

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