Nanoparticle isoflavone compositions & methods of making and using the same
AssigneeHumanetics Corporation
InventorsEdmund Joseph Elder, JR., Mark Joseph Sacchetti, Randall Joseph Tlachac, John L. Zenk
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Abstract
The present invention is directed to formulations of genistein and methods for making and using the same. In particular embodiments, the formulations described herein include suspension formulations of nanoparticulate genistein.
Claims21
1-64. (canceled)
A method of preparing nanoparticulate genistein, comprising:
- combining genistein with a pharmaceutically acceptable suspension medium, the pharmaceutically acceptable suspension medium comprising an aqueous carrier;
- nanomilling the combined genistein and pharmaceutically acceptable suspension medium to form a nanosuspension containing nanoparticulate genistein exhibiting a particle size distribution characterized by a D (0.50) of 0.5 μm or less, wherein the nanoparticulate genistein is present in the nanosuspension at a concentration of between 250 mg/mL and 500 mg/mL;
- and
- subjecting the nanosuspension to one or more post-processing steps.
An oral dosage form comprising:
- nanoparticulate genistein prepared according to a method comprising:
- combining genistein with a pharmaceutically acceptable suspension medium, the pharmaceutically acceptable suspension medium comprising an aqueous carrier;
- nanomilling the combined genistein and pharmaceutically acceptable suspension medium to form a nanosuspension containing nanoparticulate genistein exhibiting a particle size distribution characterized by a D (0.50) of 0.5 μm or less, wherein the nanoparticulate genistein is present in the nanosuspension at a concentration of between 250 mg/mL and 500 mg/mL;
- and
- subjecting the nanosuspension to one or more post-processing steps.
A method of preventing the onset of acute radiation syndrome in a subject at risk of exposure to radiation greater than 0.7 Gray or 70 rads through close proximity to radioactive material, the method comprising:
- prior to the subject being exposed to radiation, administering to the subject a therapeutically effective amount of an oral dosage form comprising nanoparticulate genistein prepared according to a method comprising:
- (i) combining genistein with a pharmaceutically acceptable suspension medium, the pharmaceutically acceptable suspension medium comprising an aqueous carrier, (ii) nanomilling the combined genistein and pharmaceutically acceptable suspension medium to form a nanosuspension containing nanoparticulate genistein exhibiting a particle size distribution characterized by a D (0.50) of 0.5 μm or less, wherein the nanoparticulate genistein is present in the nanosuspension at a concentration of between 250 mg/mL and 500 mg/mL, (iii) and subjecting the nanosuspension to one or more post-processing steps.
Dependencies are inferred from the claim text.