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Open Access Sugar and sugar-free liquid formulations of delamanid for patients with rifampicin-resistant TB

BACKGROUND: Delamanid (DLM) tablets are recommended for the treatment of rifampicin-resistant TB. However, no liquid or dispersible tablet formulation of DLM is currently commercially available for patients with challenges ingesting these tablets. The aim of this study was to develop stable extemporaneous liquid formulations of DLM that can be stored at room temperature for several weeks.

METHODS: DLM tablets were suspended in 1) simple syrup and 2) a specially formulated sugar-free vehicle. These suspensions containing DLM 5 mg/mL were stored in plastic prescription bottles at room temperature or 30°C for 30 days. These suspensions were evaluated for appearance, potency, pH, and microbial counts at Days 0, 15, and 30.

RESULTS: The potency of DLM in each formulation remained at 98–104% of the theoretical concentration for 30 days. The appearance, pH, and microbial count did not change for the sugar-free formulation during the 30-day storage period. Microbial growth, however, was observed in the simple syrup formulation on Day 30 but not on Day 15.

CONCLUSION: DLM can be formulated in sugar or sugar-free suspensions and stored at room temperature or 30°C for at least 15 and 30 days, respectively.

Keywords: DLM; antitubercular; medicine; 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, 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: January 1, 2023

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