Therapeutic systems: characteristics, differential signs, assortment analysis
- Authors: Zhilyakova E.T.1, Avtina N.V.1, Bondarev A.V.1
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Affiliations:
- Belgorod State National Research University
- Issue: Vol 71, No 5 (2022)
- Pages: 25-32
- Section: Technology of medicines
- URL: https://journal-vniispk.ru/0367-3014/article/view/144009
- DOI: https://doi.org/10.29296/25419218-2022-05-04
- ID: 144009
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Abstract
Introduction. Pharmaceutical development of medicines in the form of therapeutic systems with long-lasting effects is a priority area of pharmaceutical technology. Currently, the share of medicines registered in the State Register of Medicines as therapeutic systems is insignificant. In addition, some signs and characteristics of registered therapeutic systems (in particular, transdermal) have almost identical signs of the following dosage forms: transdermal patches, medical patches, films. In this connection, the analysis and systematization of regulatory documentation of dosage forms having similar signs and characteristics is timely and relevant.
Objective: to determine the differential signs of therapeutic systems, as a dosage form, based on the analysis of regulatory documentation and scientific and technical literature.
Material and methods. Regulatory documentation was used as research materials: general pharmacopoeia articles of the State Pharmacopoeia of the XIV ed. on medicinal forms "Therapeutic systems", "Transdermal Plasters", "Medical Plasters", "Films"; State Register of Medicines; electronic resources eLibrary, CyberLeninka. Research methods - content analysis and system analysis of regulatory documentation, the State Register of Medicines, scientific and technical publications.
Results. The analysis of the domestic market of registered medicines in the form of therapeutic systems is carried out; the main characteristics of the dosage form "Therapeutic systems" are determined, allowing to differentiate it from similar dosage forms; the classification of the dosage form "Therapeutic Systems" is proposed, which allows to fully characterize the dosage form.
Conclusion. There are eight trade names of medicines on the pharmaceutical market of the Russian Federation, the form of release of which are therapeutic systems: transdermal, intrauterine, vaginal. The main characteristics of the dosage form "Therapeutic systems" have been determined, which allow differentiating it from similar dosage forms that provide a long-lasting systemic or local pharmacological effect. The classification of the dosage form "Therapeutic systems" is proposed, which allows it to fully characterize.
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##article.viewOnOriginalSite##About the authors
Elena Teodorovna Zhilyakova
Belgorod State National Research University
Author for correspondence.
Email: ezhilyakova@bsu.edu.ru
PhD in pharmaceutical sciences, professor, head of the Department of Pharmaceutical Technology of Institute of Pharmacy, Chemistry and Biology 85 Victory str., Belgorod, 308015, Russian Federation
Natalia Valeryevna Avtina
Belgorod State National Research University
Email: avtina@bsu.edu.ru
PhD in pharmaceutical sciences, associate professor, associate professor at the Department of Pharmaceutical Technology, of Institute of Pharmacy, Chemistry and Biology 85 Victory str., Belgorod, 308015, Russian Federation
Alexander Vasilyevich Bondarev
Belgorod State National Research University
Email: bondarev_a@bsu.edu.ru
PhD in pharmaceutical sciences, associate professor of the Department of Pharmaceutical Technology 85 Victory str., Belgorod, 308015, Russian Federation
References
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