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Open Access Stable sugar and sugar-free suspensions of pretomanid

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BACKGROUND: Pretomanid (PMD) tablets are indicated as part of a combination regimen for the treatment of adults with pulmonary extensively drug-resistant, treatment-intolerant or non-responsive multidrug-resistant TB. No commercial liquid formulation is currently available for patients unable to swallow these tablets.

OBJECTIVE: To develop stable extemporaneous liquid formulations of PMD that can be stored at room temperature or 30°C for at least 4 weeks.

METHODS: Crushed PMD tablets were formulated into 20 mg/mL suspensions in a simple syrup and sugar-free formulation. The PMD formulations were stored at room temperature and at 30°C for 30 days in dispensing bottles. Appearance, pH, potency and microbial counts of the suspensions were determined on Days 0, 15 and 30.

RESULTS: The potency of PMD remained at 99.7–103.4% of the theoretical concentration in each formulation. The appearance, pH and microbial count did not change during the 30-day storage period. Simple syrup formulations did not require preservatives for microbial stability.

CONCLUSIONS: PMD oral suspension formulations in simple syrup or in sugar-free vehicle were easily prepared by utilising commonly available equipment and ingredients and were stable for 30 days. These formulations are appropriate alternatives for patients with swallowing difficulties.

Keywords: anti-tuberculosis; liquid; medicine; stability

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, 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, Tygerberg, South Africa 5: Metro TB Complex, Department of Health, Pretoria, South Africa 6: Institute for Safe Medication Practices, Horsham, PA, USA 7: Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA, Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, South Africa

Publication date: December 1, 2022

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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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