CA3221313A1 — Mixed solvents for spray drying for preparation of amorphous solid dispersions

USPTO Abstract

A method for preparing an amorphous solid dispersion by spray drying a spray solution comprising a) a mixed solvent, the mixed solvent comprising i. a solvent 1 selected from the group consisting of methyl acetate, methyl formate, ethyl acetate, ethyl formate and mixtures thereof; ii. a solvent 2 selected from the group consisting of methanol, ethanol and mixtures thereof; with the ratio (w:w) of solvent 1 to solvent 2 being from 10:90 to 90:10; b) an active agent; c) a dispersion polymer, wherein: c1) said dispersion polymer is HPMC; or c2) said dispersion polymer is PVP, provided that said mixed solvent does not consist of a mixture of methanol and ethyl acetate; or c3) said dispersion polymer is selected from the group consisting of: hydroxypropyl methylcellulose acetate succinate (HPMCAS), hydroxypropyl methylcellulose phthalate (HPMCP), hydroxypropyl cellulose (HPC), cellulose acetate phthalate (CAP), carboxymethyl ethyl cellulose (CMEC), poly(vinylpyrrolidone-co-vinyl acetate) (PVPVA), polymethacrylates such as poly(methacrylic acid-co-methyl methacrylate) (PMMAMA) or poly(methacrylic acid-co-ethyl acrylate), [acetic acid ethenyl ester, polymer with 1-ethenylhexahydro-2H- azepin-2-one and. alpha. -hydro-. omega. -hydroxypoly(oxy-I,2- ethanediyl), graft], or a combination thereof.