Evaluating human milk as a drug delivery vehicle for clofazimine to premature infants

Ponsonby-Thomas, Ellie; Salim, Malinda; Klein, Laura D.; Clulow, Andrew J.; Seibt, Susi; Boyd, Ben J.

doi:10.1016/j.jconrel.2023.08.037

Cited by 4 publications

(1 citation statement)

References 63 publications

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“…However, despite this significant accumulation of clofazimine in breastmilk, the estimated dose ingested by the breastfed infant was <0.3 mg/kg/day, much less than the currently recommended minimum therapeutic dose of 2 mg/kg/day. Interestingly, a recent investigational modelling study has shown that, as human milk enhances the solubility of clofazimine, breastmilk may be used as a delivery vehicle for infants requiring therapeutic doses of the drug [44]. As breastfed infants appear to be exposed to much lower mg/kg doses than are associated with QT interval prolongation in adults receiving 100-300 mg clofazimine [45], the potential QT-prolonging effect in breastfed infants is unlikely to be a significant safety concern at current doses.…”

Section: Clofaziminementioning

confidence: 99%

Pharmacokinetics and Safety of Group A and B Anti-Tuberculosis Drugs Used in Treatment of Rifampicin-Resistant Tuberculosis during Pregnancy and Post-Partum: A Narrative Review

Hughes

2023

Pathogens

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Recommendations for treatment of rifampicin-resistant tuberculosis (RR-TB) during pregnancy and post-partum now include Group A and B antituberculosis drugs. While pharmacokinetic data for most of these drugs among adults receiving treatment for RR-TB are limited, the data from pregnant patients and their infants are extremely scarce. Existing data suggest that fluoroquinolones, bedaquiline, clofazimine and terizidone may be used safely in pregnancy. Pharmacokinetic exposures, particularly between trimesters, are potentially sub-optimal; however, there is currently no evidence to support dose adjustment during pregnancy. Linezolid poses a potentially serious toxicity risk, particularly as exposures appear to be high in the later stages of pregnancy and post-partum following extended use, but this should be considered alongside the benefits of this extremely effective drug in the treatment of this life-threatening disease. While plenty of questions remain regarding the exposure to Group A and B antituberculosis drugs through breastmilk, existing literature suggests minimal harm to the breastfed infant. Pregnant patients and their infants should be included in therapeutic trials and pharmacokinetic studies of effective antituberculosis drugs.

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Section: Clofaziminementioning

confidence: 99%

Pharmacokinetics and Safety of Group A and B Anti-Tuberculosis Drugs Used in Treatment of Rifampicin-Resistant Tuberculosis during Pregnancy and Post-Partum: A Narrative Review

Hughes

2023

Pathogens

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From Challenges to Solution: The Evolving Landscape of Leprosy Management

Moreira,

Oliveira,

Chaves

et al. 2024

Advanced Therapeutics

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Leprosy, caused by Mycobacterium leprae, despite being a curable disease when treated can induce peripheral neuropathy. However, the medicines used in polychemotherapy promote several side effects. Thus, research for the development of new administration systems is an alternative, but there is a lack of preclinical and clinical studies of the systems, where 90.90% have a level of technological maturity 3 and 9.09% level 4. The main issues are associated with deficiencies in vitro and in vivo cultivation methodologies, lack of financing, as well as the disinterest of the pharmaceutical industry in investing in neglected tropical diseases. In addition, with the emergence of resistant bacteria, there is urgency in the search for vaccines and, therefore, in the expansion of immunomodulation studies to define the molecular targets of the vaccine and future medications. In addition, future treatments for various diseases, including leprosy, will be directly influenced by the evolution of additive manufacturing and 3D printing, seeking personalized, flexible, and reproducible treatment.

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Amphiphilic lipids for food functionality

Freire,

Salentinig

2024

Current Opinion in Colloid & Interface Science

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Evaluating human milk as a drug delivery vehicle for clofazimine to premature infants

Cited by 4 publications

References 63 publications

Pharmacokinetics and Safety of Group A and B Anti-Tuberculosis Drugs Used in Treatment of Rifampicin-Resistant Tuberculosis during Pregnancy and Post-Partum: A Narrative Review

Pharmacokinetics and Safety of Group A and B Anti-Tuberculosis Drugs Used in Treatment of Rifampicin-Resistant Tuberculosis during Pregnancy and Post-Partum: A Narrative Review

From Challenges to Solution: The Evolving Landscape of Leprosy Management

Amphiphilic lipids for food functionality

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