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Abstract

BILAYER TABLET OF ARTEMETHER & LUMEFANTRINE TABLETS: DEVELOPMENT AND EVALUATION

Sunil Kumar Shah*, Pankaj Kumar, C. K. Tyagi and Neelesh Chaubey

ABSTRACT

Present work Bi-layered tablet of Artemethar and Lumefantrine were prepared by wet granulation method, using superdisintegrants for immediate release layer and polymer like HPMC K4M and HPMC K100M for sustained release layer. Best formulations of each layer were selected for bi-layered tablet and bi-layered tablet were prepared. Bi-layered tablet of Artemethar and Lumefantrine were subjected to hardness, weight variation, friability, drug content uniformity, in vitro drug release and drug polymer interaction. FTIR and DSC studies indicated that the drug is compatible with all the excipients. Both immediate and sustained release layer were prepared by wet granulation method and punched separately. The prepared tablets of both layers were evaluated for post compression parameters. According to the in vitro dissolution profile date one formulation of each layer were selected for bi-layered tablet. IRF2 from immediate release formulations as they showed 96.62% drug release within 20 minute. SRF1 from sustained release formulation as they showed 98.18% drug release within 18 hours. The bilayer tablets were prepared using the selected immediate and sustained release layer. The prepared tablets were found to be good and free from chipping and capping. The percentage drug content was uniform in all the formulations of prepared bi-layered tablets. In vitro drug release pattern of the bi-layered tablets were same as individual layer tablets. The stability study showed that no significant changes in tablets after 3 months‟ study. Based on the observations, it can be concluded that the formulated bi-layered tablets of Artemether and Lumefantrine using superdisintegrants, release retardant polymers and different excipients was capable of exhibiting all the properties of bi-layered tablet. They are thus reducing the dose intake, minimize dose related adverse effect, cost and ultimately improve the patient compliance and drug efficiency.

Keywords: Antimalarial, Bi-layered tablet, Kinetic Release, Artemether and Lumefantrine.


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