Issn  2249-7579
e Issn  2249-7579
Publisher JOURNAL OF PHARMACEUTICAL BIOLOGY
Title

DEVELOPMENT OF ARTEMETHER AND LUMEFANTRINE FIXED DOSE COMBINATION TABLETS: PREPARATION, CHACTERIZATION AND IN-VITRO EVALUTION

Authors
Karuna DS
Department of Pharmaceutics, C. L. Baid Metha College of Pharmacy, Chennai, Tamilnadu, India
Rasheedhabanu A K
Department of Pharmaceutics, C. L. Baid Metha College of Pharmacy, Chennai, Tamilnadu, India
Ubaidulla U
Department of Pharmaceutics, C. L. Baid Metha College of Pharmacy, Chennai, Tamilnadu, India
Grace Rathnam
Department of Pharmaceutics, C. L. Baid Metha College of Pharmacy, Chennai, Tamilnadu, India
Keywords
Artemether ,Lumefantrine ,Fixed dose combination tablet ,

Abstract

The objective of this paper was to formulate and evaluate fixed dose combinations of two anti-malarial drugs, Artemether and lumefantrine. The drug-drug interactions were studied using FTIR and granules were prepared by wet granulation method using various superdisintegrants. The results of FTIR study revealed that combination of two drugs was acceptable. The prepared formulations were evaluated for various parameters like thickness, hardness, friability, disintegration time and in vitro drug release studies. The hardness, friability and disintegration time of optimized formulation F3 was found 4 to 5 kg/cm2, 0.05 to 0.07% and 2 to 3 minutes respectively. The dissolution profile of the tablet revealed that Artemether and lumefantrine were released more than 90% within 180 min, 60 min respectively. The dissolution profiles of formulation F3 and innovator product were compared by calculating similarity factor (f2) which was found to 50.08 and 69.65 for ART and LUMI respectively. The stability data reveals that the F3 showed a negligible change in drug content after storage in various conditions for three months according to ICH guidelines. Hence, it is finally concluded that the studied fixed dose combination tablet can be considered for treatment of malaria

Volume / Issue / Year

4 , 4 , 2014

Starting Page No / Endling Page No

166 - 172