Analytical Tools- Driven Compatibility and Processing Methods Study: A Case of ArtemetherLumefantrine Fixed Dose Combination Formulation

Artemisinin-based Combination Therapies (ACTs), particularly artemether and lumefantrine fixed dose combination, have been widely praised and recommended as a first-line treatment for uncomplicated falciparum malaria: The goal of this study was to figure out the best technique to use artemether-lumefantrine (AL) as model pharmaceuticals without compromising quality during processing. Analytical instruments indicated how quality was achieved by monitoring and controlling the compatibility of formulation components and the applicability of process procedures. outcome. Excipients with demonstrated performance in the wet granulation method, as well as AL as a model medication, were incorporated into six formulations, which were coded F-1 to F-6 to reflect ways of inclusion. Fourier Transform Infrared (FTIR), Differential Scanning Calorimetry (DSC), and High Performance Liquid Chromatography (HPLC) techniques were used to screen physical mixtures and wet granulated samples at various stages of processing for compatibility and method applicability as in-process materials. These instruments properly addressed the assessment of potential risks inherent in formulation and process unit operations. The matching and comparison of spectra, thermograms, and chromatograms at various stages of processing revealed no disappearance of old or appearance of new spectral bands, as well as a reduction in melting endotherm and similar characteristic elution times of AL as they transitioned from pure material to physical mixture (PM) and finally to granules. The results of this study indicated that the formulation components were compatible and that the processing techniques were suitable to the degree that the resulting granulates were suitable for further processing.

Author (S) Details

Musibau A. Mustapha
Tafapharm Limited Box 3254, Agege Post Office, Agege, Lagos, Nigeria

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