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AssigneeHollis-Eden Pharmaceuticals, Inc.
InventorsClarence Nathaniel Ahlem, Luis Daniel dos Anjos de Carvalho, William Heggie
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The invention provides compositions comprising, 16α-bromo-3β-hydroxy-5α-androstan-17-one hemihydrate and one or more excipients, typically wherein the composition comprises less than about 3% water. The compositions are useful to make improved pharmaceutical formulations. The invention also provides methods of intermittent dosing of steroid compounds such as analogs of 16α-bromo-3β-hydroxy-5α-androstan-17-one and compositions useful in such dosing regimens. The invention further provides compositions and methods to inhibit pathogen (viral) replication, ameliorate symptoms associated with immune dysregulation and to modulate immune responses in a subject using certain steroids and steroid analogs. The invention also provides methods to make and use these immunomodulatory compositions and formulations.
16α-Bromo-3β-hydroxy-5α-androstan-17-one hemihydrate substantially free of other forms of 16α-bromo-3β-hydroxy-5α-androstan-17-one, wherein less than about 2% w/w of 16β-bromo-3β-hydroxy-5α-androstan-17-one is present.
16α-Bromo-3β-hydroxy-5α-androstan-17-one hemihydrate produced by the process of contacting a solution comprising water, 16α-bromo-3β-hydroxy-5α-androstan-17-one and a C1-C6 alcohol.
16α-Bromo-3β-hydroxy-5α-androstan-17-one hemihydrate produced by the process of contacting (1) an organic solution comprising 16α-bromo-3β-hydroxy-5α-androstan-17-one and an organic solvent and (2) water.
16α-Bromo-3β-hydroxy-5α-androstan-17-one hemihydrate milled to an average particle size of about 0.01-200 μm.
A product comprising 16α-bromo-3β-hydroxy-5α-androstan-17-one hemihydrate and one or more excipients produced by the process of contacting 16α-bromo-3β-hydroxy-5α-androstan-17-one hemihydrate that contains less than about 2% w/w of 16β-bromo-3β-hydroxy-5α-androstan-17-one and one or more excipients.
A formulation suitable for administration to a human or an animal comprising 16α-bromo-3β-hydroxy-5α-androstan-17-one hemihydrate that contains less than about 2% w/w of 16β-bromo-3β-hydroxy-5α-androstan-17-one and an excipient, wherein the formulation is suitable for administration by parenteral, sublingual, buccal, topical or aerosol administration.
Dependencies are inferred from the claim text.