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
    info

    Universidad de La Laguna

    San Cristobal de La Laguna, España

    ROR https://ror.org/01r9z8p25

Revista:
Pharmaceutical Sciences

ISSN: 1735-403X

Ano de publicación: 2021

Tipo: Artigo

DOI: 10.34172/PS.2021.46 GOOGLE SCHOLAR lock_openAcceso aberto editor

Outras publicacións en: Pharmaceutical Sciences

Indicadores

Citas recibidas

  • Citas en Scopus: 1 (09-01-2023)

SCImago Journal Rank

  • Ano 2021
  • Impacto SJR da revista: 0.187
  • Cuartil maior: Q3
  • Área: Pharmacology, Toxicology and Pharmaceutics (miscellaneous) Cuartil: Q3 Posición na área: 61/114
  • Área: Pharmaceutical Science Cuartil: Q3 Posición na área: 112/189

Scopus CiteScore

  • Ano 2021
  • CiteScore da revista: 1.5
  • Área: Pharmacology, Toxicology and Pharmaceutics (all) Percentil: 46
  • Área: Pharmaceutical Science Percentil: 41

Journal Citation Indicator (JCI)

  • Ano 2021
  • JCI da revista: 0.22
  • Cuartil maior: Q4
  • Área: PHARMACOLOGY & PHARMACY Cuartil: Q4 Posición na área: 319/361

Resumo

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.