Drug development and industrial pharmacy · 2026
Pre-formulation studies and orodispersible formulation of solidagenone, a labdane diterpene from Solidago chilensis Meyen, with potential anti-asthmatic activity.
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Lopes Deise Cristina Drummond Xavier Paes, Silva Isadora Guimarães da, Soares Ana Beatriz Souza, Ferreira Leide Lene Coelho, Dos Santos Matos Ana Paula, Oliveira Temistocles Barroso, Valverde Simone Sacramento, Viçosa Alessandra Lifsitch, Junior Eduardo Ricci
Аннотация
OBJECTIVE: This study aimed to develop and characterize orodispersible tablets (ODTs) containing solidagenone (SLG), a bioactive constituent of Solidago chilensis Meyen with described anti-inflammatory properties and potential relevance to asthma management.
SIGNIFICANCE: ODTs offer advantages for patients with swallowing difficulties and may improve adherence in chronic respiratory conditions.
METHODS: SLG underwent physicochemical and solid-state characterization (FTIR, particle size, SEM morphology, XRPD, DSC, and TGA). Two SLG-loaded ODT formulations (3 mg) and their respective placebos were produced by direct compression and assessed for weight uniformity, hardness, friability, diameter, thickness, disintegration time, and SLG content.
RESULTS: SLG exhibited a predominantly crystalline hexagonal-pyramidal morphology and thermal stability up to approximately 190 °C. All ODT formulations complied with the friability specifications of the Brazilian Pharmacopeia, 6th edition (≤1%), with hardness values ranging from approximately 40-60 N. SLG-loaded tablets demonstrated fast disintegration (12.6 ± 2.6-17.0 ± 4.0 s), with the optimized formulation meeting both European Pharmacopeia (≤180 s) and FDA/USP (<30 s) criteria for ODTs. Chromatographic analysis confirmed SLG content and integrity in the optimized formulation.
CONCLUSION: These results support SLG as a promising candidate for orodispersible tablet formulation development, encouraging further pharmacodynamic and clinical studies to explore its potential application in asthma management.
SIGNIFICANCE: ODTs offer advantages for patients with swallowing difficulties and may improve adherence in chronic respiratory conditions.
METHODS: SLG underwent physicochemical and solid-state characterization (FTIR, particle size, SEM morphology, XRPD, DSC, and TGA). Two SLG-loaded ODT formulations (3 mg) and their respective placebos were produced by direct compression and assessed for weight uniformity, hardness, friability, diameter, thickness, disintegration time, and SLG content.
RESULTS: SLG exhibited a predominantly crystalline hexagonal-pyramidal morphology and thermal stability up to approximately 190 °C. All ODT formulations complied with the friability specifications of the Brazilian Pharmacopeia, 6th edition (≤1%), with hardness values ranging from approximately 40-60 N. SLG-loaded tablets demonstrated fast disintegration (12.6 ± 2.6-17.0 ± 4.0 s), with the optimized formulation meeting both European Pharmacopeia (≤180 s) and FDA/USP (<30 s) criteria for ODTs. Chromatographic analysis confirmed SLG content and integrity in the optimized formulation.
CONCLUSION: These results support SLG as a promising candidate for orodispersible tablet formulation development, encouraging further pharmacodynamic and clinical studies to explore its potential application in asthma management.