Extractables: Componentes del dispositivo de pulverización y del envase probados para extraíbles a fin de garantizar la compatibilidad con la formulación liposomal de apolactoferrina/lactoferrina
Leachables: Materiales del envase evaluados en cuanto a lixiviables para confirmar que no afectan la estabilidad de los liposomas ni la seguridad nasal
Dimensional Accuracy: Dimensiones de la boquilla de pulverización y del actuador controladas con precisión para entregar una dosis medida constante en cada activación

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APOLACT Nasale TDC spray is a Class I medical device combining apolactoferrin and lactoferrin within liposomes, alongside sorbitol, designed for nasal hygiene, hydration, and protection. Liposomes are lipid spheres that protect and release apo-lactoferrin. Lactoferrin (LTF) is an iron-chelating glycoprotein that defends the body against a wide range of pathogens; its antimicrobial and anti-inflammatory effects largely stem from its ability to bind free Fe3+ iron, a key cofactor for microbial growth and free radical production. Its antiviral action comes from binding plasma membrane glycosaminoglycans, blocking viral entry and halting infection at the outset. Apolactoferrin, the iron-free form of lactoferrin, is five times more active than lactoferrin itself, since its open apoprotein form binds iron more readily, giving it easier access to Fe3+ ions.