Rehydratable pharmaceutical product

摘要

A pharmaceutical product comprising lyophilized polymer matrix including a biologically active compound, of particular utility for embolization, having improved rehydration properties is packaged in an airtight package under vacuum.

主权项

1. A method of preparing a pharmaceutical suspension for administration to an animal comprising the steps:
i) providing particles of polymer matrix swollen with water and having absorbed therein a non-volatile biologically active compound wherein the polymer is a water-insoluble water-swellable pharmaceutically acceptable polymer; ii) cooling the swollen particles from step i) in a freezing step to a temperature below the freezing point for water whereby the water in the polymer matrix forms absorbed ice; iii) in a lyophilisation step subjecting the cooled particles from step ii) to a reduced pressure at which ice sublimes for a period during which at least a portion of the absorbed ice sublimes and water vapour is removed; iv) in a packaging step, packaging the dried particles under reduced pressure and into a package that is substantially airtight and has an interior under vacuum to form packaged particles; v) storing the package for optionally a storage period of 1 day to 10 years; and vi) rehydrating the dried particles by adding to the package of dried product a pharmaceutically acceptable sterile aqueous liquid, without allowing ingress of air, and, optionally, a contrast medium, to form a suspension of swollen particles in the aqueous liquid, wherein said swollen particles in the suspension in the aqueous liquid have particle sizes in the range 40 to 2000 μm.