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OwnerKilyoung Kim, Mahesh V. Patel +2inventors
InventorsKilyoung Kim, Mahesh V. Patel, Nachiappan Chidambaram, Joel Frank
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Disclosed are bioavailable solid state (17-β)-3-Oxoandrost-4-en-17-yl dodecanoate compositions and methods of use in administration to mammals in need of thereof. The (17-β)-3-Oxoandrost-4-en-17-yl dodecanoate is preferably provided in a solid state crystalline form having a plurality of peaks corresponding to the peaks shown in FIG. 2, a plurality of crystallites ranging in size from about 40 nm to about 60 nm based as identified via powder x-ray diffraction spectra, and a melting point in the range of about 51° C. to about 63° C. The compositions may be provided in oral or injectable administration form for the treatment of conditions such as in need of testosterone therapy. An exemplary chemical structure of a (17-β)-3-Oxoandrost-4-en-17-yl dodecanoate composition disclosed herein is as follows:
A crystalline form of (17-β)-3-Oxoandrost-4-en-17-yl dodecanoate having an XRD pattern comprising at least five peaks selected from the group of angles of 10.9±0.2, 13.6±0.2, 14.0±0.2, 15.3±0.2, 17.3±0.2, 18.0±0.2, 19.2±0.2, and 23.2±0.2 measured relative to two-theta (2θ).
A pharmaceutical composition comprising a crystalline form of (17-β)-3-Oxoandrost-4-en-17-yl dodecanoate having an XRD pattern comprising at least five peaks selected from the group of angles of 10.9±0.2, 13.6±0.2, 14.0±0.2, 15.3±0.2, 17.3±0.2, 18.0±0.2, 19.2±0.2, and 23.2±0.2 measured relative to two-theta (2θ) and at least one additive.
A pharmaceutical composition for an oral or injectable administration comprising a crystalline form of (17-β)-3-Oxoandrost-4-en-17-yl dodecanoate having an XRD pattern comprising at least five peaks selected from the group of angles of 10.9±0.2, 13.6±0.2, 14.0±0.2, 15.3±0.2, 17.3±0.2, 18.0±0.2, 19.2±0.2, and 23.2±0.2 measured relative to two-theta (2θ) and at least one additive.
A pharmaceutical composition comprising a crystalline form of (17-β)-3-Oxoandrost-4-en-17-yl dodecanoate having an XRD pattern comprising at least five peaks selected from the group of angles of 10.9±0.2, 13.6±0.2, 14.0±0.2, 15.3±0.2, 17.3±0.2, 18.0±0.2, 19.2±0.2, and 23.2±0.2 measured relative to two-theta (2θ) and at least one carrier, said carrier comprising at least one of a lipophilic carrier and a hydrophilic carrier.
A pharmaceutical composition for treating a condition for which testosterone is needed, said composition comprising a crystalline form of (17-β)-3-Oxoandrost-4-en-17-yl dodecanoate having an XRD pattern comprising at least five peaks selected from the group of angles of 10.9±0.2, 13.6±0.2, 14.0±0.2, 15.3±0.2, 17.3±0.2, 18.0±0.2, 19.2±0.2, and 23.2±0.2 measured relative to two-theta (2θ) and at least one additive.
A pharmaceutical composition comprising a crystalline form of (17-β)-3-Oxoandrost-4-en-17-yl dodecanoate having an XRD pattern comprising at least five peaks selected from the group of angles of 10.9±0.2, 13.6±0.2, 14.0±0.2, 15.3±0.2, 17.3±0.2, 18.0±0.2, 19.2±0.2, and 23.2±0.2 measured relative to two-theta (2θ) and at least one additive, wherein said composition is for the treatment of at least one of carcinoma, sarcoma, melanoma, lymphoma, leukemia, end-stage to liver disease, end-stage lung disease, end-stage kidney disease, end-stage musculoskeletal system disease, end-stage cardiovascular disease, end-stage blood disease, end-stage endocrine gland disease, end-stage gastrointestinal disease, end-stage skin disease, end-stage genital organ disease, end-stage central nervous system disease, hepatic fibrosis, hepatic inflammation, hepatic steatosis, non-alcoholic steatohepatitis (NASH), non-alcoholic fatty liver disease (NAFLD), pre/post liver transplant, cirrhosis, primary biliary cholangitis (PBC), lung disease affecting the interstitium, interstitial lung disease (ILD), pneumonia, idiopathic pulmonary fibrosis (IPF), muscle mass wasting, cachexia, sarcopenia, frailty, type 1 diabetes, type 2 diabetes, hyperglycemia, glucose intolerance, hypogonadism, hypogonadotropic hypogonadism, a metabolic syndrome, visceral adiposity, obesity, impaired wound healing, large waist, and hereditary angioedema.
A crystalline form of (17-β)-3-Oxoandrost-4-en-17-yl dodecanoate having a) the chemical structure of an XRD pattern comprising at least five peaks selected from the group of angles of 10.9±0.2, 13.6±0.2, 14.0±0.2, 15.3±0.2, 17.3±0.2, 18.0±0.2, 19.2±0.2, and 23.2±0.2 measured relative to two-theta (2θ), b) a melting point in the range of about 51° C. to about 63° C., and c) a plurality of crystallites ranging in size from about 40 nm to about 60 nm.
A pharmaceutical composition comprising at least one additive and a crystalline form of (17-β)-3-Oxoandrost-4-en-17-yl dodecanoate having a) the chemical structure of an XRD pattern comprising at least five peaks selected from the group of angles of 10.9±0.2, 13.6±0.2, 14.0±0.2, 15.3±0.2, 17.3±0.2, 18.0±0.2, 19.2±0.2, and 23.2±0.2 measured relative to two-theta (2θ), b) a melting point in the range of about 51° C. to about 63° C., and c) a plurality of crystallites ranging in size from about 40 nm to about 60 nm, wherein said composition is for the treatment of at least one of carcinoma, sarcoma, melanoma, lymphoma, leukemia, end-stage liver disease, end-stage condition related to lung disease, end-stage condition related to kidney disease, end-stage musculoskeletal system disease, end-stage cardiovascular disease, end-stage blood disease, end-stage endocrine gland disease, end-stage gastrointestinal disease, end-stage skin disease, end-stage genital organ disease, end-stage central nervous system disease, hepatic fibrosis, hepatic inflammation, hepatic steatosis, non-alcoholic steatohepatitis (NASH), non-alcoholic fatty liver disease (NAFLD), pre/post liver transplant, cirrhosis, primary biliary cholangitis (PBC), lung disease affecting the interstitium, interstitial lung disease (ILD), pneumonia, idiopathic pulmonary fibrosis (IPF), muscle mass wasting, cachexia, sarcopenia, frailty, type 1 diabetes, type 2 diabetes, hyperglycemia, glucose intolerance, hypogonadism, hypogonadotropic hypogonadism, a metabolic syndrome, visceral adiposity, obesity, impaired wound healing, large waist, and hereditary angioedema, and wherein said pharmaceutical composition is formulated for at least one of oral administration and injectable administration, and wherein said pharmaceutical composition for oral administration further comprises at least one of a tablet, a capsule, a caplet, a gelcap, a suspension, a solution, a drink, a gel, a syrup, a dispersion, an emulsion, a sprinkle, a lozenge, a microemulsion, a nanoemulsion, an elixir, a paste, a powder, and a granule, and wherein said pharmaceutical composition for injectable administration further comprises at least one of an intravenous injectable, an intramuscular injectable, a subcutaneous injectable, an intradermal injectable, an intraspinal injectable, an intrathecal injectable, and an intra-arterial injectable comprising at least one of an implant, a solution, a suspension, an emulsion, a microemulsion, a nanoemulsion, a gel, a liposome, and a pellet.
Dependencies are inferred from the claim text.