Pre-formulation studies and orodispersible formulation of solidagenone, a labdane diterpene from Solidago chilensis Meyen, with potential anti-asthmatic activity.

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.