Biosafety of obtaining and using transdermal delivery systems for antihypertensive drugs in the form of microneedles
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Дата
2025
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Видавець
КПІ ім. Ігоря Сікорського
Анотація
The article is devoted to the study of biosafety of obtaining and using a system of transdermal delivery of antihypertensive drugs in the form of microneedles, which is an innovative approach to the treatment of hypertension. The process of obtainingmicroneedle arrays from titanium, which are characterized by high biocompatibility, chemical inertness and mechanical strength, is presented. Particular attention is paid to the issues of ensuring sterility at all stages of production, which complies with international standards ISO 14644 and GMP, as well as technical regulations for medical devices (DSTU EN ISO 13485).The study of literaturesources has shown that the use of titanium minimizes the risks of safety, cytotoxic and inflammatory reactions due to the formation of a stable TiO₂ oxide film on the surface of microneedles. Based on the results of the studies, no critical side effects were identified in 95% of cases, while temporary, minor manifestations in 5% of cases disappeared on their own without theneed for additional treatment.Post-market monitoring showed that the control of drug release from the porous structure of microneedles ensures a stable therapeutic effect without the risk of overdose. Thus, the developed transdermal delivery system demonstrates high biosafety,which makes it a promising alternative to injectable and oral routes.
Опис
Ключові слова
biosafety, transdermal delivery, microneedles, antihypertensive drugs, arterial hypertension, biocompatibility, sterility, dosage control, environmental safety, mechanical strength, біобезпека, трансдермальна доставка, мікроголки, антигіпертензивні засоби, артеріальна гіпертензія, біосумісність, стерильність, контроль дозування, екологічна безпека, механічна міцність
Бібліографічний опис
Bachynska, Y. Біобезпека отримання та використання систем трансдермальної доставки антигіпертензивних засобів у вигляді мікроголок / Yana Bachynska, Tatiana Lutsenko // Біомедична інженерія і технологія. – 2025. – Том 2. – № 17: Біобезпека. Спецвипуск. – С. 1-10. – Бібліогр.: 25 назв.