Uporedna studija o proceni rizika elementarnih nečistoća u Montelukast tabletama za žvakanje i filmom obloženim tabletama

  • Stefan Angelevski Replek Farm d.o.o.
  • Irena Slaveska Spirevska Replek Farm d.o.o.
  • Elena Lazarevska Todevska Replek Farm d.o.o.
  • Tanja Bakovska Stoimenova Replek Farm d.o.o.
  • Marija Glavaš Dodov „Sv. Kiril i Metodije” Univerzitet u Skoplju, Farmaceutski fakultet
  • Maja Simonoska Crcarevska „Sv. Kiril i Metodije” Univerzitet u Skoplju, Farmaceutski fakultet
  • Renata Slaveska Raički „Sv. Kiril i Metodije” Univerzitet u Skoplju, Farmaceutski fakultet
DOI: https://doi.org/10.5937/arhfarm73-41263
Ključne reči: elementarne nečistoće, Montelukast, procena rizika, ICH Q3D (R2), komparativna studija

Sažetak


Dobro je dokumentovano da su elementarne nečistoće (EN) kritične u oblasti farmaceutskog razvoja jer mogu uticati na kvalitet, efikasnost i bezbednost finalnog oblika leka (FOL). Odgovornost proizvođača farmaceutskih proizvoda je da pokažu, preko pristupa procene, strategije kontrole zasnovane na riziku, i/ili potrebne analize podataka, da su FOL usaglašeni sa ICH Q3D (R2). Bez obzira na to, praktična primena ICH Q3D (R2) smernice i usklađenost FOL-a sa ICH Q3D (R2) uvek predstavljaju izazov za farmaceutsku industriju. Cilj ovog istraživanja je da se sprovede detaljna komparativna studija procene rizika od EN za tri različita dozirana oblika Montelukasta proizvedenih kao tablete za žvakanje (4 mg i 5 mg) i film obložene tablete od 10 mg. Sistem induktivno spregnute plazma-masene spektrometrije (ICP-MS) korišćen je za određivanje EN u uzorcima montelukast natrijuma, kao aktivne komponente, placeba za sve FOL i FOL. Nakon toga, analize su takođe sprovedene na tri serije iz sva tri proučavana FOL-a. Na osnovu ICH Q3D (R2) smernice, testirani proizvodi za EN, klasa 1 i klasa 2A pokazali su da su nivoi EN u aktivnoj komponenti i placebu znatno ispod oralnih i parenteralnih granica ICH Opcije 1. Za ispitivane serije svake FOL jačine (ukupno 9), nijedan EN ne prelazi njihove granice koncentracije.

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Objavljeno
2023/02/27
Broj časopisa
Vol. 73 Br. Notebook 1 (2023): Arhiv za farmaciju
Rubrika
Stručni rad
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