Abstract: Disclosed is a method and an oral composition for treating CNS disorders. An embodiment of the invention comprises orally administering an allopregnanolone containing composition to a subject having a CNS disorder. Exemplary CNS disorders include sleep disorders, mood disorders, dysthymic disorders, bipolar disorders, anxiety disorders, stress disorders, compulsive disorders, schizophrenia spectrum disorders, convulsive disorders, memory disorders, cognition disorders, movement disorders, personality disorders, autism spectrum disorders, substance abuse disorders, dementia, pain, traumatic brain injury (TBI), vascular disease, withdrawal syndrome, and tinnitus. The composition and methods disclosed herein exhibit effective oral absorption/bioavailability.

Abstract: Disclosed are pharmaceutical compositions and oral dosage forms including capsules containing (17-?)-3-oxoandrost-4-en-17-yl tridecanoate, and related methods. The capsule fill can include an additive and about 14 wt % to about 42 wt % for androst-4-en-17?-ol-3-one esters that comprise (17-?)-3-oxoandrost-4-en-17-yl tridecanoate or a combination of (17-?)-3-oxoandrost-4-en-17-yl undecanoate, (17-?)-3-oxoandrost-4-en-dodecanoate, and (17-?)-3-oxoandrost-4-en-17-yl tridecanoate. A single oral administration to a male subject of one or more dosage forms with a total androst-4-en-17?-ol-3-one equivalent dose of about 150 mg to about 895 mg is provided. In another embodiment, a method for providing a serum concentration of androst-4-en-17?-ol-3-one within a target PK performance for a male subject is provided.

Abstract: Disclosed are bioavailable solid state (17-?)-Hydroxy-4-Androsten-3-one esters suitable for pharmaceutical uses and administration to mammals in need of (17-?)-Hydroxy-4-Androsten-3-one. Pharmaceutical compositions and the dosage forms of the bioavailable solid state (17-?)-Hydroxy-4-Androsten-3-one esters can be used to treat any condition associated with testosterone deficiency, including complete absence of endogenous testosterone in male or female subjects.

Abstract: Disclosed is a method and composition for treating CNS disorders in a subject. In an embodiment, the method preferably comprises the ordered steps of identifying a subject having or being predisposed to epilepsy, and orally administering to the subject an AED. The administration preferably comprises an administration regimen of a predetermined quantity of the AED, at a predetermined frequency, and for a predetermined duration. The subject preferably comprises a subject experiencing seizure clusters, WWE, and more especially a WWE of childbearing age. The composition preferably comprises a NAS, and more especially an ENAS. The method preferably results in the prevention, or reduced frequency or magnitude of epileptic seizures.

Abstract: Disclosed are methods and oral compositions for treating CNS disorders. An embodiment of the invention comprises orally administering a 3?-OH-5?-pregnan-20-one containing composition to a subject having a CNS disorder. The composition preferably exhibits a fast release rate of the 3?-OH-5?-pregnan-20-one. The current compositions may provide desired serum levels of 3?-OH-5?-pregnan-20-one to effectively treat CNS disorders. The oral compositions and methods disclosed herein may be administered to a subject in need of CNS disorder therapy, to deliver therapeutically effective amounts of 3?-OH-5?-pregnan-20-one for treating CNS disorders.

Abstract: Described here are substantially pure (17-?)-3-Oxoandrost-4-en-17-yl tridecanoate compositions, methods of their preparation and uses thereof.

Abstract: Disclosed are methods and compositions for testosterone replacement therapy, especially for use in administration to hypogonadal males. The methods and compositions employ a fixed dose dosing regimen that does not require titration or dose adjustments and that can provide a therapeutically effective amount of a non-undecanoate testosterone ester while avoiding unacceptably high testosterone levels.

Abstract: Disclosed are pharmaceutical compositions and oral dosage forms including capsules containing (17-?)-3-oxoandrost-4-en-17-yl tridecanoate, and related methods. The capsule fill can include an additive and about 14 wt % to about 42 wt % for androst-4-en-17?-ol-3-one esters that comprise (17-?)-3-oxoandrost-4-en-17-yl tridecanoate or a combination of (17-?)-3-oxoandrost-4-en-17-yl undecanoate, (17-?)-3-oxoandrost-4-en-dodecanoate, and (17-?)-3-oxoandrost-4-en-17-yl tridecanoate. A single oral administration to a male subject of one or more dosage forms with a total androst-4-en-17?-ol-3-one equivalent dose of about 150 mg to about 895 mg is provided. In another embodiment, a method for providing a serum concentration of androst-4-en-17?-ol-3-one within a target PK performance for a male subject is provided.

Abstract: An HPC composition and method of treatment for the prevention of PTB and improved neonatal outcomes. The invention provides for a dosing regimen beginning as early as 14 weeks of fetal gestation and dosing regimens of a duration of as much as 25 weeks. The invention provides a high level of exogeneous progestin to endogenous progesterone when it is most needed. The instant invention consistently achieves active levels of HPC which achieve effectiveness. Exemplary dosing regimens comprise an oral administration of HPC in the range of 1,200 mg to 1600 mg, wherein the HPC is administered via a once a day, twice a day, or three times a day administration.

Abstract: The present invention provides for bioavailable oral dosage forms containing esters of 17-hydroxyprogesterone as well as related methods. The oral dosage forms can be formulated for pregnancy support and can include a therapeutically effective amount of an ester of 17-hydroxyprogesterone and a pharmaceutically acceptable carrier. In another embodiment, a pharmaceutically acceptable oral dosage form for pregnancy support is provided. The pharmaceutically acceptable oral dosage can include a therapeutically effective amount of an ester of 17-hydroxyprogesterone and a pharmaceutically acceptable carrier. The oral dosage form can, when measured using a USP Type-II dissolution apparatus in 900 mL of deionized water with 0.5 (w/v) of sodium lauryl sulfate at 50 RPM at 37° C., release at least 20 wt % of the dose of the ester of 17-hydroxyprogesterone after 60 minutes, or in the alternative release at least 20 wt % more after 60 minutes than an equivalently dosed oral dosage form without the carrier.

Abstract: The present disclosure provides methods and compositions for testosterone replacement therapy. The methods and compositions employ a fixed dose dosing regimen that does not require titration or dose adjustments and that can provide a therapeutically effective amount of a testosterone ester while avoiding unacceptably high testosterone levels.

Abstract: The present disclosure is drawn to compositions and methods for treating CNS disorders. In one embodiment, an oral pharmaceutical composition can comprise a therapeutically effective amount of pregn-4-ene-3,20-dione; and a pharmaceutically acceptable carrier that provides formation of either 3?-OH-5?-pregnan-20-one, or 3?-OH-5?-pregnan-20-one, or both in an amount sufficient to treat a CNS disorder when orally administered to a subject. In another embodiment, a method of treating a CNS disorder can comprise orally administering to a subject, a therapeutically effective amount of pregn-4-ene-3,20-dione that provides an amount of GABA receptor binding pregn-4-ene-3,20-dione metabolites that is sufficient to treat the CNS disorder.

Abstract: The present disclosure is drawn to compositions and methods for treating CNS disorders. In one embodiment, an oral pharmaceutical composition can comprise a therapeutically effective amount of pregn-4-ene-3,20-dione; and a pharmaceutically acceptable carrier that provides formation of either 3?-OH-5?-pregnan-20-one, or 3?-OH-5?-pregnan-20-one, or both in an amount sufficient to treat a CNS disorder when orally administered to a subject. In another embodiment, a method of treating a CNS disorder can comprise orally administering to a subject, a therapeutically effective amount of pregn-4-ene-3,20-dione that provides an amount of GABA receptor binding pregn-4-ene-3,20-dione metabolites that is sufficient to treat the CNS disorder.

Abstract: Disclosed are bioavailable solid state (17-?)-3-Oxoandrost-4-en-17-yl dodecanoate compositions and methods of use in administration to mammals in need of thereof. The (17-?)-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.

Abstract: The present invention provides for bioavailable oral dosage forms containing esters of 17-hydroxyprogesterone as well as related methods. The oral dosage forms can be formulated for pregnancy support and can include a therapeutically effective amount of an ester of 17-hydroxyprogesterone and a pharmaceutically acceptable carrier. In another embodiment, a pharmaceutically acceptable oral dosage form for pregnancy support is provided. The pharmaceutically acceptable oral dosage can include a therapeutically effective amount of an ester of 17-hydroxyprogesterone and a pharmaceutically acceptable carrier. The oral dosage form can, when measured using a USP Type-II dissolution apparatus in 900 mL of deionized water with 0.5 (w/v) of sodium lauryl sulfate at 50 RPM at 37° C., release at least 20 wt % of the dose of the ester of 17-hydroxyprogesterone after 60 minutes, or in the alternative release at least 20 wt % more after 60 minutes than an equivalently dosed oral dosage form without the carrier.

Abstract: Systems and methods are provided for mobile treatment of an exhaust stream. A treatment assembly including an inlet. A coupling is configured to releasably couple the inlet with an outlet of a stationary processing facility that produces an exhaust stream. The treatment assembly receives the exhaust stream in an input stream, treats at least one constituent of the input stream, and produces a treated exhaust. The treatment assembly is decouplable from the stationary processing facility and transportable to various locations.

Abstract: Disclosed are effective fixed dose oral testosterone undecanoate compositions for use in regimens without dose titration and methods for treatment of patients in need of testosterone replacement therapy. Also disclosed are criteria for continuation and discontinuation of such regimens, based on single serum T concentration levels measured at a steady state at predetermined times after initiation of said regimen and at a predetermined number of hours after administration of a morning dose of the regimen.

Abstract: The present disclosure is drawn to pharmaceutical compositions and oral dosage capsules containing testosterone undecanoate, as well as related methods. The capsule includes a capsule shell and a capsule fill. The capsule fill can include a solubilizer and about 14 wt % to about 35 wt % testosterone undecanoate based on the total capsule fill. The oral dosage capsule is such that when a single oral administration to a male subject of one or more capsules with a total testosterone undecanoate daily dose of about 350 mg to about 650 mg it provides a ratio of serum testosterone Cmax to serum testosterone Cave of about 2.7 or less. In yet another embodiment, a method for providing a serum concentration of testosterone within a target serum testosterone concentration Cave range for a male subject is provided.

Abstract: Disclosed are bioavailable solid state (17-?)-3-Oxoandrost-4-en-17-yl dodecanoate compositions and methods of use in administration to mammals in need of thereof. The (17-?)-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.

Abstract: The present disclosure is drawn to pharmaceutical compositions and oral dosage capsules containing testosterone undecanoate, as well as related methods. The capsule includes a capsule shell and a capsule fill. The capsule fill can include a solubilizer and about 14 wt % to about 35 wt % testosterone undecanoate based on the total capsule fill. The oral dosage capsule is such that when a single oral administration to a male subject of one or more capsules with a total testosterone undecanoate daily dose of about 350 mg to about 650 mg it provides a ratio of serum testosterone Cmax to serum testosterone Cave of about 2.7 or less. In yet another embodiment, a method for providing a serum concentration of testosterone within a target serum testosterone concentration Cave range for a male subject is provided.