Composition of and method for preparing stable particles in a frozen aqueous matrix
OwnerJames Kipp, Mark Doty +3inventors
InventorsJames Kipp, Mark Doty, Christine Rebbeck, Sean Brynjelsen, Jamie Konkel
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Abstract
The present invention discloses a composition of a stable suspension of a poorly water soluble pharmaceutical agent or cosmetic in the form of particles of the pharmaceutical agent or cosmetic suspended in a frozen aqueous matrix and method for its preparation. The composition is stable for a prolonged period of time, preferably six months or longer and is suitable for parenteral, oral, or non-oral routes such as pulmonary (inhalation), ophthalmic, or topical administration.
Claims104
A composition of a suspension of a poorly water soluble compound comprising particles of a crystalline phase pharmaceutical agent or an amorphous phase pharmaceutical agent in a frozen aqueous matrix, wherein the compound has a solubility in water of less than 10.0 mg/ml, and wherein about over 99% of the particles have a particle size of less than about 5 microns.
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A method for stabilizing a suspension of a poorly water soluble compound in an aqueous matrix comprising the steps of:
- providing a suspension of a crystalline phase pharmaceutical agent or an amorphous phase pharmaceutical agent in an aqueous matrix, wherein the compound has a solubility in water of less than 10.0 mg/ml, and wherein about over 99% of the particles have a particle size of less than about 5 microns;
- and freezing the aqueous suspension.
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Dependencies are inferred from the claim text.