Solid Dosage Forms with Fixed-Dose Combinations of Active Pharmaceutical Ingredients: Therapeutic Importance and Review of Formulation Strategies

Nevena Maksimović; Jelena Đuriš

doi:10.5937/arhfarm76-67662

Nevena Maksimović Univerzitet u Beogradu – Farmaceutski fakultet, Katedra za farmaceutsku tehnologiju i kozmetologiju, Beograd, Srbija
Jelena Đuriš Univerzitet u Beogradu – Farmaceutski fakultet, Katedra za farmaceutsku tehnologiju i kozmetologiju, Beograd, Srbija

DOI: https://doi.org/10.5937/arhfarm76-67662

Ključne reči: lekovi sa kombinacijom fiksnih doza, formulacioni pristupi, klinički značaj

Sažetak

Lekovi sa kombinacijom fiksnih doza (engl. Fixed-Dose Combination, FDC proizvodi) sadrže najmanje dve lekovite supstance u jednom farmaceutskom obliku. Monolitni, višeslojni i višečestični sistemi su najčešći tipovi čvrstih farmaceutskih oblika (tableta i kapsula) u kojima se formulišu FDC proizvodi. Od tehnologija koje se koriste u proizvodnji najčešće se koristi pristup aktivne filmske obloge i oblaganje kompresijom, a sve veća pažnja se poklanja 3D štampanju FDC proizvoda. Veoma je važan pravilan odabir formulacione strategije za razvoj ovih lekova kako bi se njihovi nedostaci sveli na minimum. Iz kliničke perspektive, ovi lekovi nude bolju efikasnost, bezbednost i podnošljivost u lečenju oboljenja i stanja poput hipertenzije, dijabetesa tipa 2 i tuberkuloze, u terapiji bola, raznih infekcija, hormonskih poremećaja i kontracepcije. Iz perspektive pacijenta, nude praktičnost i pojednostavljenje terapije kroz smanjenje broja potrebnih tableta i/ili kapsula, posebno kod pacijenata koji su na politerapiji zbog kompleksnih stanja i/ili komorbiditeta, što rezultira povećanim stepenom adherence kod pacijenata, a samim tim i poboljšanjem uspešnosti terapije i kvaliteta života pacijenata.

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Čvrsti farmaceutski oblici sa kombinacijom fiksnih doza lekovitih supstanci: terapijski značaj i pregled formulacionih strategija

Sažetak

Reference