Crystalline ingenol mebutate
AssigneeLeo Pharma A/S
InventorSteven Martin OGBOURNE
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Abstract
The present invention relates to a novel crystalline form of ingenol mebutate, methods of preparation thereof, and to its use. More specifically, the invention relates to the conversion of amorphous ingenol mebutate (ingenol-3-angelate, PEP005) to a crystalline form, which was characterized by single crystal X-Ray crystallography (XRC), attenuated total reflectance Fourier transform infrared (FTIR-ATR) spectroscopy and Differential Scanning calorimetry (DSC).
Claims42
Crystalline ingenol mebutate.
Ingenol mebutate having a purity of at least about 99.5%.
A method of making a pharmaceutical composition comprising crystalline ingenol mebutate, the method comprising combining crystalline ingenol mebutate with a pharmaceutically acceptable carrier or vehicle.
A process for preparing crystalline ingenol mebutate, which comprises (a) dissolving an amount of ingenol mebutate in a solvent or solvent mixture, (b) optionally adding water, (c) cooling the solution to a temperature at which about the full amount of ingenol mebutate is no longer soluble in the solution, and (d) isolating by filtration any ingenol mebutate crystals that are formed.
A pharmaceutical composition for topical application to a treatment area of a subject to deliver topically an effective amount of a crystalline ingenol mebutate to treat a skin disorder in the treatment area, said pharmaceutical composition comprising an effective amount of a crystalline ingenol mebutate and a pharmaceutically acceptable vehicle.
Dependencies are inferred from the claim text.