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Open Access Extemporaneously compounded liquid formulations of clofazimine

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BACKGROUND: Clofazimine (CFZ) is routinely used worldwide for the treatment of leprosy and TB. However, no liquid or dispersible tablet formulations of CFZ are currently available commercially for patients with challenges ingesting soft gelatin capsules or solid formulations. The aim of this research was to develop stable extemporaneous liquid formulations of CFZ that can be stored at room temperature for several weeks to enable practical dosing in the field.

METHODS: Two formulations were prepared in syrup and sugar-free vehicles with CFZ tablets using a simple method that can be used in a routine pharmacy. Suspensions were stored at room temperature and at 30°C for 30 days. Formulation aliquots were tested on Days 0, 15 and 30 for appearance, pH, potency and microbial counts.

RESULTS: Appearance remained unchanged during storage. The pH of both formulations was between 4.0 and 6.0. Potency was between 90% and 110% for 30 days in the syrup formulation and for 15 days in the sugar-free formulation. Microbial counts met United States Pharmacopeia <1111> limits for oral aqueous liquids and specific organisms were absent.

CONCLUSIONS: A simple field-friendly method was successfully developed for the preparation of CFZ liquid formulations using commonly available ingredients. This will permit practical dosing and titration for children and other patients with swallowing challenges.

Keywords: anti-tuberculosis; medicine; stability; suspension

Document Type: Research Article

Affiliations: 1: Global Alliance for TB drug Development (TB Alliance), New York, NY, USA 2: Institute of Therapeutic Innovations and Outcomes, Colleges of Pharmacy and Medicine, The Ohio State University, Columbus, OH, USA 3: JSAS Services Inc, Tucson, AZ, USA 4: Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa 5: Metro TB Complex, Department of Health, Pretoria, South Africa 6: Institute for Safe Medication Practices, Plymouth Meeting, PA, USA 7: Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa, Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA

Publication date: February 1, 2023

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  • The International Journal of Tuberculosis and Lung Disease (IJTLD) is for clinical research and epidemiological studies on lung health, including articles on TB, TB-HIV and respiratory diseases such as COVID-19, asthma, COPD, child lung health and the hazards of tobacco and air pollution. Individuals and institutes can subscribe to the IJTLD online or in print – simply email us at [email protected] for details.

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