DAİLY ARIAS RAMOS, IDELSY CHIL NÚÑEZ, HUMBERTO J MORRIS QUEVEDO, JULİO A ROJAS VARGAS, YAİXA BELTRÁN DELGADO, YAMİLA LEBEQUE PÉREZ, PAUL COS
Acta Pharmaceutica Sciencia - 2025;63(3):656-681
The study was aimed to evaluate the potential of Pleurotus ostreatus granules as a raw material for developing solid dosage forms. Drug-excipient compatibility was assayed using 1:1 binary mixtures and the ratio of formulation components was optimised with a D-optimal design considering flow properties as response variables. Three batches of granules were produced with the optimised mixture by the wet granulation method. The quality of the granules was evaluated based on physical, rheological, chemical, and microbiological parameters. The concentration of phenolic compounds in the binary mixtures remained unchanged at 30°C, but decreased at 45°C and 60°C. Moreover, a quadratic model was used to fit the response variables. Mixing design allowed selecting the best excipient ratio. The granules showed a residual moisture content and a particle size lesser than 5% and 350 µm, respectively, as well as, excellent flow and compressibility properties, and optimal microbiological quality.
