Vývoj formulace antistresových pastilek připravených lisováním s využitím frakčního faktoriálního designu Latin cube a přístupu ANOVA

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Autoři: Oleksii Yakovenko ¹; Tetiana Kolisnyk ¹; Lena Ruban ¹; Natalia Fil ²
Působiště autorů: Department of Industrial Technology of Drugs, National University of Pharmacy, Ukraine ¹; Department of Automation and Computer-Integrated Technologies, Kharkiv National Automobile and Highway University, Ukraine ²
Vyšlo v časopise: Čes. slov. Farm., 2021; 70, 66-78
Kategorie: Původní práce
doi: https://doi.org/10.5817/CSF2021-2-66

Souhrn

Cílem práce bylo vyvinout antistresové pastilky obsahující 100 mg glycinu a 250 mg magnesium-citrátu získané metodou přímého lisování. Aby bylo možné zvolit optimální složení pomocných látek poskytující dostatečné kvalitativní vlastnosti tabletoviny, mechanickou pevnost tablet a jejich odolnost a pomalé rozpouštění v ústech, bylo připraveno a testováno 27 experimentálních formulací podle frakčního faktoriálního designu latinských čtverců. Pomocné látky použité ve studii byly: Mannogem® EZ, Cellactose®80 a GalenIQ™ 721 (plniva); Plasdone™ S-630, Kollidon® 90 F a Avicel® PH-101 (suchá pojiva); Metolose® 90SH-4000SR a klovatina guar (gelotvorné látky); PRUV®, Neusilin® US2 a Compritol® 888 CG ATO (antifrakční pomocné látky). Byly zkoumány následující parametry: sypná hustota, Carrův index, oděr, pevnost a doba rozpadavosti in vitro. Pro statistické zpracování byl použit přístup ANOVA, který umožnil odhalit jednotlivé vlivy každé použité pomocné látky a několik interakčních účinků pozorovaných u množství excipientů použitých v této studii. Isomalt (GalenIQ™ 721), kopovidon (Plasdone™ S-630) a glycerylbehenát (Compritol® 888 CG ATO) byly vybrány pro začlenění do konečné formulace lisovaných pastilek.

Klíčová slova:

lisované pastilky – glycin – magnesium-citrát – aktivita chránící proti stresu – vývoj formulace – návrh experimentu – analýza rozptylu

Zdroje

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