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β-Lactoglobulin, A Novel Excipient for Next Generation Spray-Dried Powder Formulations

Lino PR, Costa C, Gentilal N, Lopes M, Mestre M, Gamelas B, Diogo J, Henriques P, Ferreira F, Churro R, Saldanha S, Galésio M, Ribeiro A.

Respiratory Drug Delivery 2025. Volume 1, 2025: 18-26.

Abstract:

This study explores the potential of Dispersome®, which leverages the protein β-lactoglobulin (BLG) as a novel excipient in dry powder formulations for respiratory delivery. BLG formed dispersible and high-density composite particles via spray drying. Key findings include (i) optimized spray drying conditions to obtain BLG particles with high fine particle fractions up to 90%; (ii) demonstrated BLG compatibility with active pharmaceutical ingredients like fluticasone furoate (FF) and a model antibiotic (MA); (iii) stabilization of amorphous FF and MA (up to 75% drug load w/w) dispersions; (iv) high nasal deposition of BLG-based formulations; (v) pulmonary and systemic clearance in Sprague-Dawley rats within 24 hours after being inhaled, with minimal immune responses and no observed toxicity at 0.67 mg/kg and 18 mg/kg of daily doses administered for three weeks. These results support BLG as a promising novel excipient for respiratory drug delivery that needs to be further developed for pharmaceutical applications.