Pre-formulation studies and orodispersible formulation of solidagenone, a labdane diterpene from Solidago chilensis...

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.

ODTs offer advantages for patients with swallowing difficulties and may improve adherence in chronic respiratory conditions.

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.

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.

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.