Patent ID: 8415329

Claim:
An injectable aqueous terminally steam sterilized composition consisting essentially of a particulate suspension of a water insoluble or poorly soluble biologically active substance wherein the particles in the suspension have a volume weighted mean particle size of up to 3 μm, with not more than 3000 particles of a size of 10 μm or greater and not more than 300 particles of a size of 25 μm or greater, and said particles are surface stabilized with one or more phospholipid surface modifiers and a pharmaceutically acceptable amount of a water soluble polyhydroxy thermoprotecting agent selected from the group consisting of trehalose, lactose, dextrose, sorbitol, dextran, mannitol and mixtures thereof, wherein said thermoprotecting agent is present in an amount effective to restrict an increase in volume weighted mean diameter of said suspension during and after terminal steam sterilization, wherein the ratio of said active substance to said phospholipid surface modifier is from about 3:1 to about 5:1 and the amount of said phospholipid surface modifier is in the range from about 0.2% w/w to about 5.0% w/w, wherein said composition is devoid of surfactants that require during terminal steam sterilization elevation of their cloud point temperature by addition of a cloud point modifier, said composition being devoid of surfactant additives which coagulate on steam sterilization.