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US 2020/0046733 A1Published application
Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
AssigneeClarus Therapeutics, Inc.
InventorsRobert E. DUDLEY, Panayiotis P. CONSTANTINIDES
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Abstract
A drug delivery system for oral administration of hydrophobic drugs with enhanced and extended absorption and improved pharmacokinetics is provided. In one embodiment, formulations comprising testosterone and testosterone esters, e.g., testosterone palmitate, are disclosed. Methods of treating a hormone deficiency or effecting male contraception with the inventive formulations are also provided.
Claims7
-17. (canceled)
A method of treating a hypogonadal human male with testosterone deficiency comprising
- orally administering to a human male in need thereof an oral pharmaceutical composition comprising 15-20 percent by weight of solubilized testosterone undecanoate, 5-20 percent by weight of hydrophilic surfactant,
- wherein the formulation consists of a liquid or semi-solid encased in a capsule, wherein said administration is twice daily, and
- wherein the administration provides an average serum concentration of testosterone at steady state of about 300 ng/dl to about 1100 ng/dl.
Dependencies are inferred from the claim text.