Impact of storage conditions on a new child-friendly dispersible tablet for treating Tuberculosis in pediatrics.

  1. González, Javier Suárez 1
  2. Santoveña Estévez, Ana 1
  3. Soriano, Mabel
  4. Fariña, Jose Bruno 1
  1. 1 Universidad de La Laguna

    Universidad de La Laguna

    San Cristobal de La Laguna, España


Pharmaceutical Sciences

ISSN: 1735-403X

Year of publication: 2021

Type: Article

DOI: 10.34172/PS.2021.46 GOOGLE SCHOLAR lock_openOpen access editor

More publications in: Pharmaceutical Sciences


Cited by

  • Scopus Cited by: 2 (05-09-2023)
  • Web of Science Cited by: 2 (31-08-2023)
  • Dimensions Cited by: 1 (12-03-2023)

SCImago Journal Rank

  • Year 2021
  • SJR Journal Impact: 0.187
  • Best Quartile: Q3
  • Area: Pharmacology, Toxicology and Pharmaceutics (miscellaneous) Quartile: Q3 Rank in area: 61/122
  • Area: Pharmaceutical Science Quartile: Q3 Rank in area: 111/197

Scopus CiteScore

  • Year 2021
  • CiteScore of the Journal : 1.5
  • Area: Pharmacology, Toxicology and Pharmaceutics (all) Percentile: 46
  • Area: Pharmaceutical Science Percentile: 41

Journal Citation Indicator (JCI)

  • Year 2021
  • Journal Citation Indicator (JCI): 0.22
  • Best Quartile: Q4
  • Area: PHARMACOLOGY & PHARMACY Quartile: Q4 Rank in area: 319/361


(Data updated as of 12-03-2023)
  • Total citations: 1
  • Recent citations: 1
  • Field Citation Ratio (FCR): 0.27


Background: In 2020 the composition and procedure to elaborate a new formulation containing Isoniazid, Pyrazinamide and Rifampicin to treat tuberculosis in pediatric patients was published. The temperature and relative humidity in Tuberculosis-endemic countries are high, > 30ºC and > 70% respectively and thus these meteorological conditions required a new dosage form. The objective of this work is to register changes in tablet quality and stability over time when exposed to different storage conditions according to ICH. Method: Tablets were subjected to accelerated, long term and low relative humidity conditions. The effect of light was also tested. Quality was measured by evaluating weight changes tensile strength, disintegration time, and drug content. Hydrazine formation was also evaluated as it is considered a mutagenic degradation product. Results: Tablets stored at low relative humidity showed the best stability. There was no statistically significant difference between tablets exposed to or protected from light. Moreover, the formation of Hydrazine was not detected during stability studies. Conclusion: This new dosage form for treating Tuberculosis is stable and able to maintain its quality when appropriate storage conditions are used.