Abstract: Provided is a composition comprising (i) a nano- or microparticle formulation of a therapeutically active agent which is suspended in a liquid phase, and (ii) at least one cryoprotective additive selected from C3-C5 alkanes substituted by one or two hydroxy groups which stabilizes the particle formulation. Further aspects relate to a solid composition which can be obtained by freezing the stabilized composition, and to processes for the preparation of the compositions in accordance with the invention.

Abstract: The invention relates to an aqueous suspension formulation for aerosol formation, said suspension formulation comprising lipid or lipidoid nanoparticles which are suspended in an aqueous vehicle solution, wherein the lipid or lipidoid nanoparticles comprise the following components (a) and (b): (a) a nucleic acid and (b) an ionizable lipid or an ionizable lipidoid; and wherein the aqueous vehicle solution comprises a triblock copolymer which contains one poly(propylene oxide) block and two poly(ethylene oxide) blocks. Moreover, the invention relates to an aerosol obtained from the formulation for aerosol formation.

Abstract: Provided is a composition comprising (i) a nano- or microparticle formulation of a therapeutically active agent which is suspended in a liquid phase, and (ii) at least one cryoprotective additive selected from C3-C5 alkanes substituted by one or two hydroxy groups which stabilizes the particle formulation. Further aspects relate to a solid composition which can be obtained by freezing the stabilized composition, and to processes for the preparation of the compositions in accordance with the invention.