Development and Characterization of Combinational Formulations of Artemether and Lumefantrine in Mcroneedles Nanosponges and Dry Syrup in Nanoparticulate form

Abstract

Malaria, a parasite born life-threatening disease, is the prominent cause of morbidity and mortality worldwide. Malaria is generally caused by a parasite belonging to the genus newlinePlasmodium, which are unicellular organisms that cannot survive outside of their hosts. The five major species of parasite that cause malaria are P. falciparum, P. vivax, P. ovale, P. knowlesi and P. malariae. The two species that pose the greatest threat to humans are P. falciparum and P. vivax. According to the World Health Organization Report (2018), approximately 228 million newlinecases and 405000 deaths occurred from malaria worldwide. The most vulnerable group affected newlineby malaria is children less than 5 years of age and accounted for 272000 (67%) deaths newlineworldwide. (World Malaria Report, 2018). newlineArtemether and lumefantrine are WHO approved artemisinin-based combination that belongs to newlineBCS class IV drugs with log P values 3.48 and 9.19, respectively and is used to treat acute newlineuncomplicated malaria. (Amin et al., 2013). Presently, the combination of artemether and newlinelumefantrine is commercialized as tablets and suspension for oral ingestion. However, the newlinelimitations of conventional drug delivery systems include: (a) requirement of a higher dose of newlineactives, (b) lower effectiveness rate, (c) toxic action, (d) adverse side effects, (e) solubility newlinerelated issues in the case of BCS class II and IV drugs, (f) fluctuating drug plasma concentration newlineor absorption is irregular, (g) acidic degradation of actives by gastro-intestinal enzymes and (h) newlinepoor bioavailability. (Savjani et al., 2012). To overcome the drawbacks of conventional systems, newlineNovel Drug Delivery Systems (NDDSs) are preferred by combining the use of advanced newlinetechnologies and newer dosage forms. NDDS reduces the dosing frequency to address patient compliance, increases the therapeutic action, modulates the release patterns and improves the bioavailability of actives. (Bhagat and Vaidhya, 2013). The various micro- and nano-carriers used in novel drug delivery system include: liposomes,