Formulation Development and Evaluation of Artemether 20 MG/Lumefantrine 120 MG Fixed Dose Combination Tablet
Background: Prevailing trends in the global Pharmaceutical sector pose various barriers to Africa’s access to essential Pharmaceutical products. Pharmaceutical Research and Development pipelines are running dry. In Tanzania, due to inadequate number of formulation experts and poor technology, the availability of various essential drugs is still inadequate and inconsistent; and this explains why more than 90% the recommended first line drug for treatment of uncomplicated malaria (Artemether Lumefantrrine) are imported. Aim of the study: The aim was to develop a formulation of Artemether 20 mg/Lumefantrine 120 mg Fixed Dose Combination Tablet. Materials and methods: This was an experimental study design conducted at Muhimbili University of Health and Allied Sciences, in a Research and Development Laboratory December 2019 to July 2020. A wet granulation method was used by mixing a required amount of Active Pharmaceutical Ingredients (APIs) with a suitable amount of potential excipients. The compression of powder granules was done on a tablet press EKOI 2 (Manufactured in Germany). Evaluation of dissolution profile between the innovator drug and the formulated drug product of this study was conducted; the similarity and differences were calculated as per International Pharmacopoeia. Friability, Disintegration time, Assay and tablets contents uniformity of the formulated drug product are the critical parameters that were also evaluated as per United States Pharmacopoeia. Results: Tablets were successfully produced with the average weight of 240 mg, diameter 10 mm and thickness of 6 mm. The similarity and difference of 89% and 4.1% respectively were obtained. Friability, Disintegration time, Assay and tablets contents uniformity results were found to be 2 minutes and 29 seconds, Arte-98.1% Lum-99.2%, and Arte-98.0% Lume-101.3% respectively. Conclusion: The formulated and evaluated drug product of Artemether 20 mg and Lumefantrine 120 mg fixed dose combination tablet passed the quality requirements as per International Pharmacopoeias and Monographs. Scale up by our local pharmaceutical industry may be done by adopting this formula but should adhere to the official compendia.
Ibrahimu Kaswamila, Mary J. Temu, Eliangiringa Kaale, Betty Maganda, Raphae Shedafa, Prosper Tibelinda, Silas Shemdoe, Juma M. Ayubu
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