Evidence map›Paper›PMID 36853102›Full record

ArticleThe international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease2023

Extemporaneously compounded liquid formulations of clofazimine.

R Taneja, M C Nahata, J Scarim, P G Pande, A Scarim, G Hoddinott, C L Fourie, R K Jew, H S Schaaf, A C Hesseling and 1 more

Abstract read
In one paragraph

Article in The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. A novel home-based method for preparing suspensions of anti-TB drugs.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2023
    Article
  5. Community perspective on child-friendly medications for drug-resistant TB: importance, priorities and advocacy.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2023
    Article
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

R TanejaGlobal Alliance for TB drug Development (TB Alliance), New York, NY, USA.
M C NahataInstitute of Therapeutic Innovations and Outcomes, Colleges of Pharmacy and Medicine, The Ohio State University, Columbus, OH, USA.
J ScarimJSAS Services Inc, Tucson, AZ, USA.
P G PandeGlobal Alliance for TB drug Development (TB Alliance), New York, NY, USA.
A ScarimJSAS Services Inc, Tucson, AZ, USA.
G HoddinottDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
C L FourieMetro TB Complex, Department of Health, Pretoria, South Africa.
R K JewInstitute for Safe Medication Practices, Plymouth Meeting, PA, USA.
H S SchaafDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
A C HesselingDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
A J Garcia-PratsDesmond 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.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundClofazimine (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.

methodsTwo 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.

resultsAppearance 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.

conclusionsA 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.

Indexed as

ClofazimineDrug CompoundingPharmaceutical ServicesChildHumansLeprosyTuberculosisClofazimine

Identifiers

PMID36853102
PMCPMC9904399

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.