ó㳺íà íàñåëåíèõ ì³ñöü | ISSN: 2707-0441 eISSN: 2707-045X |
Âèïóñê 69, 2019 - Ñòîð³íêè: 261-269
ÈÑÏÎËÜÇÎÂÀÍÈÅ ÁÈÎÔÀÐÌÀÖÅÂÒÈ×ÅÑÊÎÉ ÊËÀÑÑÈÔÈÊÀÖÈÎÍÍÎÉ ÑÈÑÒÅÌÛ ÄËß ÎÏÒÈÌÈÇÀÖÈÈ ÊÎÍÒÐÎËß ÊÀ×ÅÑÒÂÀ ËÅÊÀÐÑÒÂÅÍÍÛÕ ÏÐÅÏÀÐÀÒΠÍÀ ÐÛÍÊÅ ÓÊÐÀÈÍÛ
ͳêîëàºâà ß.Þ.1, Îñòàí³íà Í.Â.1, Ëåâ³í Ì.Ã.1
1 ÄÓ "²ÍÑÒÈÒÓÒ ÃÐÎÌÀÄÑÜÊÎÃÎ ÇÄÎÐÎÂ'ß ²Ì. Î.Ì. ÌÀÐǪªÂÀ ÍÀÌÍÓ"
ÓÄÊ: 615.074
ÀÍÎÒÀÖ²ß:
Íàçâà ñòàòò³: ÂÈÊÎÐÈÑÒÀÍÍß Á²ÎÔÀÐÌÀÖÅÂÒÈ×Íί ÊËÀÑÈÔ²ÊÀÖ²ÉÍί ÑÈÑÒÅÌÈ ÄËß ÎÏÒÈ̲ÇÀÖ²¯ ÊÎÍÒÐÎËÞ ßÊÎÑÒ² ˲ÊÀÐÑÜÊÈÕ ÏÐÅÏÀÐÀҲ ÍÀ ÐÈÍÊÓ ÓÊÐÀ¯ÍÈ.
Ìåòà: âèçíà÷èòè ìîæëèâ³ ñïîñîáè îïòèì³çàö³¿ êîíòðîëþ ÿêîñò³ ë³êàðñüêèõ çàñîá³â íà ðèíêó Óêðà¿íè íà îñíîâ³ âèêîðèñòàííÿ Á³îôàðìàöåâòè÷íî¿ Êëàñèô³êàö³éíî¿ Ñèñòåìè.
Îá'ºêò äîñë³äæåííÿ. Á³îôàðìàöåâòè÷íà Êëàñèô³êàö³éíà Ñèñòåìà, ÿêà âèêîðèñòîâó-ºòüñÿ ïðè îïòèì³çàö³¿ êîíòðîëþ ÿêîñò³ ë³êàðñüêèõ ïðåïàðàò³â.
Ðåçóëüòàòè äîñë³äæåííÿ òà ¿õ îáãîâîðåííÿ. Ñüîãîäí³ ïðè çàñòîñóâàíí³ ë³êàðñüêèõ çàñîá³â ÷àñòî ³ñíóº ïðîáëåìà â³äñóòíîñò³ ïåðåäáà÷åíîãî òåðàïåâòè÷íîãî, ïðîô³ëàêòè÷íîãî åôåêòó, àáî íàâïàêè, ñïîñòåð³ãàþòüñÿ ïîá³÷í³ ä³¿.
Äëÿ åôåêòèâíî¿ îðãàí³çàö³¿ êîíòðîëþ ÿêîñò³ îðàëüíèõ ë³êàðñüêèõ ïðåïàðàò³â ç ä³þ÷îþ ðå÷îâèíîþ, ÿêà çíàõîäèòüñÿ ó âèãëÿä³ òâåðäî¿ ôàçè, íåîáõ³äíî âèêîðèñòîâóâàòè êîíöåïö³þ Á³îôàðìàöåâòè÷íî¿ Êëàñèô³êàö³éíî¿ Ñèñòåìè (ÁÊÑ), çîêðåìà, âðàõîâóâàòè äàí³ ïî ïðîíèê-íîñò³ ³ ðîç÷èííîñò³ â³äïîâ³äíèõ ë³êàðñüêèõ ñóáñòàíö³é (ËÑ). Òàêèì ÷èíîì, ãîëîâíèì àñïåê-òîì, ùî ïîâ'ÿçàíèé ç îá³ãîì ë³êàðñüêèõ çàñîá³â, º çàáåçïå÷åííÿ ¿õ áåçïåêè òà åôåêòèâíîñò³.
Àñïåêòîì áåçïåêè º íåáåçïåêà êîíòàêòó ðîç÷èíåíî¿ ËÑ, ùî âîëî䳺 âèñîêîþ ïðîíèê-í³ñòþ, ç òèìè îáëàñòÿìè øëóíêîâî-êèøêîâîãî òðàêòó (ØÊÒ), ÿê³ íå ïðèçíà÷åí³ äëÿ àáñîðá-ö³¿.
Àñïåêòîì åôåêòèâíîñò³ º äîñòàòíÿ ïîâíîòà àáñîðáö³¿ ËÇ ç ë³êàðñüêîãî ïðåïàðàòó.
Íàéá³ëüø ïðîáëåìíèìè ³ òèìè, ùî âèìàãàþòü ï³äõîä³â, ÿê³ âèõîäÿòü çà ðàìêè ôàðìà-êîïåéíèõ ìåòîä³â ³ ìåòîä³â êîíòðîëþ ÿêîñò³ (ÌÊÊ), íà äóìêó àâòîð³â, º ïðåïàðàòè 2 ³ 4 êëàñ³â ÁÊÑ.
Âèñíîâêè.  äàíèé ÷àñ âèíèêëà íåîáõ³äí³ñòü âèêîðèñòîâóâàòè ÁÊÑ äëÿ îïòèì³çàö³¿ êîíòðîëþ ÿêîñò³ òâåðäèõ îðàëüíèõ ë³êàðñüêèõ ïðåïàðàò³â íà ðèíêó Óêðà¿íè. Ðîçãëÿíóòî ³ îïèñàíî ïîòåíö³éí³ ìîæëèâîñò³ âèêîðèñòàííÿ ÁÊÑ äëÿ äàíî¿ îïòèì³çàö³¿, ùî äîçâîëèòü á³ëüø åôåêòèâíî âèÿâëÿòè ë³êàðñüê³ ïðåïàðàòè, ÿê³ ìîæóòü ìàòè ïîòåíö³éí³ ïðîáëåìè ç á³îäîñòóïí³ñòþ / á³îåêâ³âàëåíòí³ñòþ. Îáãîâîðåíî ìîæëèâ³ øëÿõè òàêî¿ îïòèì³çàö³¿. Äàíà êîíöåïö³ÿ äîçâîëèòü íàïðàâèòè ðåñóðñè êîíòðîëþþ÷èõ îðãàí³â íà âèÿâëåííÿ «ïðîáëåìíèõ» ãðóï ë³êàðñüêèõ ïðåïàðàò³â.
ÊËÞ×β ÑËÎÂÀ:
Á³îôàðìàöåâòè÷íà Êëàñèô³êàö³éíà Ñèñòåìà, ðîç÷èíí³ñòü, ïðîíèêí³ñòü, êîíòðîëü ÿêîñò³, ãåíåðèêè, âèïðîáóâàííÿ «Ðîç÷èíåííÿ», âèïðîáóâàííÿ «Ðîçïàäàííÿ».
˲ÒÅÐÀÒÓÐÀ:
1. Lobenberg R., Amidon G.L. Modern bioavailability, bioequivalence and biopharmaceutics classification system. New scientific approaches to international regulatory standards. European Journal of Pharmaceutics and Biopharmaceutics. 2000. Vol. 50 (1). P. 3-12.
3. Yohey Kawabata, Koichi Wada, Manabu Nakatani, ShizuoYamada, Satomi Onoue. Formulation design for poorly water-soluble drugs based on biopharmaceutics classification system: Basic approaches and practical applications. International Journal of Pharmaceutics. 2011. Vol. 420 (1). P. 1– 10. DOI :
https://doi.org/10.1016/j.ijpharm.2011.08.032
8. Äåðæàâíà ñëóæáà Óêðà¿íè ç ë³êàðñüêèõ çàñîá³â òà êîíòðîëþ çà íàðêîòèêàìè. URL :
http://dls.gov.ua
11. Pharmaceutical Dosage Forms: TABLETS, Third Edition. Volume 1: Unit Operations and Me-chanical Properties. Ed. by Augsburger L.L. & Hoag S.W. Informa Healthcare USA, Inc, 2008. 311 p. DOI :
https://doi.org/10.3109/9781420020281
12. Singh S., Rama Rao K.V., Venugopal K., Manikandan R. Alteration in Dissolution Characteristics of Gelatin-Containing Formulations. A Review of the Problem, Test Methods, and Solutions. Pharmaceutical Technology. 2002. April. P. 36-58.
18. Kappelle W.F., Siersema P.D., Bogte A., Vleggaar F.P. Challenges in oral drug delivery in patients with esophageal dysphagia. Expert Opinion on Drug Delivery. 2016. Vol. 13(5). P. 645-658. DOI :
https://doi.org/10.1517/17425247.2016.1142971
19. Mounica P., Pavani S., Mounica Rani P. A review on recent advances in enteric coating and enteric polymers. World Journal of Pharmaceutical Research. 2018. Vol. 7, Iss. 2. P. 475-495. DOI:
https://doi.org/10.20959/wjpr20182-10795
ÄËß ÖÈÒÓÂÀÍÍß:
Íèêîëàåâà ß.Þ., Îñòàíèíà Í.Â., Ëåâèí Ì.Ã. Èñïîëüçîâàíèå áèîôàðìàöåâòè÷åñêîé êëàññèôèêàöèîííîé ñèñòåìû äëÿ îïòèìèçàöèè êîíòðîëÿ êà÷åñòâà ëåêàðñòâåííûõ ïðåïàðàòîâ íà ðûíêå Óêðàèíû. ó㳺íà íàñåëåíèõ ì³ñöü : çá. íàóê. ïð. Ê., 2019. Âèï. 69. Ñ. 261-269.