ArticleDrug development and industrial pharmacy2025
Storage and in-use stability of an excipient enhanced growth (EEG) synthetic lung surfactant powder formulation.
Article in Drug development and industrial pharmacy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
objectiveTo evaluate the storage and in-use stability of a novel synthetic lung surfactant (SLS) excipient enhanced growth (EEG) powder formulation. SIGNIFICANCE: Aerosol delivery of surfactant formulations could address limitations of current instilled surfactant replacement therapy for neonatal respiratory distress syndrome. A stable surfactant powder formulation is essential for this approach.
methodsSLS-EEG powder was spray-dried from a formulation of dipalmitoyl -phosphatidylcholine (DPPC), surfactant protein B peptide mimic (B-YL), mannitol, sodium chloride, and l-leucine. Powders were filled into hydroxypropyl methylcellulose (HPMC) capsules and stored in aluminum-aluminum blisters at 25 °C, 5 °C and -20 °C (all ± 2 °C) and 40 ± 5% relative humidity (RH) for 6 months. Physicochemical and aerosol properties were assessed post-spray drying and post-storage. In-use stability was assessed by exposing powders to 22 °C/45% RH for 30 and 120 min and 30 °C/75% RH for 120 min before dry powder inhaler (DPI) actuation.
resultsDPPC content remained stable for 6 months at all storage temperatures. Powder morphology and particle size were unchanged at 5 °C and -20 °C, but altered at 25 °C. Solid-state stability and surface activity were unaffected. Emitted doses remained high (>95%) after 3 months using an infant air-jet DPI, though
conclusionsA synthetic lung surfactant EEG powder formulation with physicochemical stability and acceptable aerosol performance up to 6 months storage has been successfully produced.
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