Abstract: A SEDDS or SMEDDS or SNEDDS formulation for drug delivery of a lipophilic therapeutic agent, providing enhanced modulation of solubility, stability, absorption, metabolism, and/or pharmacokinetic profile of the therapeutic agent by formulation with a lipophilic surfactant, a hydrophilic surfactant, one or more solubilizers and, optionally, digestible oils, resulting in higher bioavailability of the therapeutic agent administered to a subject in need of such therapeutic agent. Also described are pharmaceutical compositions containing the formulations and methods of making and methods of using the formulations and pharmaceutical compositions. Formulations of the disclosure can be constituted to minimize the synthesis of dihydrotestosterone when the therapeutic agent includes testosterone or testosterone esters.

Abstract: The present invention relates to non-toxic consumable compositions and formulations comprising chelator and base having synergistic effects on microbial metabolism and/or growth and/or pathogenic effectors and their use to promote and maintain health in mammals. The current invention also relates to non-toxic consumable compositions comprising more than one chelator and/or more than one base. The present invention further relates to methods for selecting said chelator and base composition and methods for detecting conditions in which selected compositions may be used. The present invention relates to the synergistic compositions and methods of their use for maintaining health, promoting health and treating diseases.

Abstract: Screening methods as well as kits for identifying modulators of hydroxysteroid (17-beta) dehydrogenase (HSD17B) family member proteins, such as HSD17B13, are provided. The methods comprise screening molecules for their capacity to modulate the HSD17B family member protein, including inhibiting the HSD17B family member protein, as measured by substrate depletion, product concentration from the HSD17B family member protein substrate conversion or NADH concentration, levels of labeled substrate, luciferin light emission, or combinations thereof. Inhibitors of HSD17B family member proteins identified through the screening methods may be used to treat liver diseases, disorders, or conditions in which the HSD17B family member protein plays a role.

Abstract: A method of making a liquid dispersion for the manufacture of a photonic crystal. The method comprises dispersing monodispersed spheres in a liquid to form a liquid dispersion, and subjecting the liquid dispersion to an ultrasonic treatment. Ammonia solution may also be added to the liquid dispersion. The ultrasound treatment breaks up agglomerations of monodispersed spheres, and the resulting photonic crystal made using the dispersion is more highly ordered and hence of higher quality.

Abstract: Formulations of comprising a neuroactive steroid, e.g., allopregnanolone; and optionally a cyclodextrin, e.g., a ?-cyclodextrin, e.g., a sulfo butyl ether ?-cyclodextrin, e.g., a ?-cyclodextrin, e.g., a sulfo butyl ether ?-cyclodextrin, e.g., CAPTISOL®; and methods of use in treating CNS disorders.

Abstract: What is disclosed is a controlled release pharmaceutical composition comprising a biocompatible and bioerodible semi-solid gel comprising a mixture of a triglyceride of ricinoleic acid and a gelling agent, in a formulation with loteprednol, latanoprost, celecoxib, triamcinolone, or betamethasone and, optionally, a second corticosteroid, analgesic, or anti-inflammatory agent.

Abstract: Compounds are provided according to Formula (I): and pharmaceutically acceptable salts thereof, and pharmaceutical compositions thereof; wherein R1, R2, R3 and R6, R11a, and R11b are as defined herein. Compounds of the present invention are contemplated useful for the prevention and treatment of a variety of conditions.

Abstract: A hypothalamic-pituitary-gonadal (HPG) axis of a patient in need thereof is rebalanced by administering a therapeutically effective amount of at least one donor cell.

Abstract: The present invention relates to injectable, extended-release, pharmaceutical formulations comprising a nalbuphine ester prodrug homogenously dissolved in a solution comprising a pharmaceutically acceptable oil and an oil-miscible retaining solvent, as well as manufacturing processes and medical uses of the formulations. The invention further provides methods for adjusting the duration of action of the formulations by varying the ratio of the pharmaceutically acceptable oil and the oil-miscible retaining solvent.

Abstract: The present invention relates to injectable, extended-release, pharmaceutical formulations comprising a nalbuphine ester prodrug homogenously dissolved in a solution comprising a pharmaceutically acceptable oil and an oil-miscible retaining solvent, as well as manufacturing processes and medical uses of the formulations. The invention further provides methods for adjusting the duration of action of the formulations by varying the ratio of the pharmaceutically acceptable oil and the oil-miscible retaining solvent.

Abstract: Described are novel female fertility therapies. A first aspect of the invention is directed to therapies that include FSH lowering methodologies to prevent and/or treat egg infertility. A second aspect of the invention is directed to agents that bind to activin, bind to receptors that bind activin, or that otherwise disrupt activin signaling (collectively referred to herein as “activin pathway modifier agents” or “APM agents”) and methods of utilizing these agents to prevent and/or treat egg infertility. A third aspect of the invention is directed to methods of administering an effective amount of an APM agent to a subject to increase oocyte yield and/or ovarian reserve. All three aspects of the invention may be used in humans and in animals. Additional aspects of the invention include therapeutic drug kits for treatment of humans and animals based on the methodologies described above.

Abstract: The present disclosure provides for methods of treating or preventing a cardiovascular disorder and/or a related pulmonary disorder in a subject. In certain embodiments, the method comprises administering a therapeutically effective amount of an inhibitor of Glucose-6-phosphate dehydrogenase (G6PD), or a pharmaceutically acceptable salt, non-salt amorphous form, solvate, poly-morph, tautomer or prodrug thereof.

Abstract: The present application provides a compound of formula I: or a pharmaceutically acceptable salt, solvate, or amino acid conjugate thereof, wherein R1-R10, m, n, p, and are as described herein. The present invention relates generally to FXR modulators and to methods of making and using said compounds.

Abstract: The present invention discloses an amino mercaptan compound, preparation method thereof and use thereof in radiation protection. The compound has the structure of formula I, wherein A1, A2, R1, R2, R5, R6, and R3 and R4 are defined herein. The compound has the effects of reducing the biological damage caused by ionizing radiation, extending the survival period and survival rate of the radiated animals, and significantly alleviating the side effects of radiotherapy, and has a low toxicity. The present invention opens up a new way for protection and treatment of ionizing radiation damage.

Abstract: The present invention provides a method for preparing a cell culture medium comprising a mixture of blood products from two or more donors, comprising the steps of: a) providing at least a first blood product from a first donor; b) measuring the concentration of at least one quality factor in the first blood product; c) comparing the measured concentration of a quality factor to a concentration range predefined for the quality factor; d) selecting the first blood product for the cell culture medium if the concentration measured for the quality factor is in the predefined range and optionally converting the first selected blood product into a first processed blood product or else unselecting the first blood product.

Abstract: The invention relates to a time controlled, immediate release drug delivery system for oral administration of a first active ingredient to a subject in need thereof. The invention additionally relates to a dual drug delivery device, comprising the time controlled, immediate release drug delivery system according to the invention, further comprising a second coating comprising a second active ingredient.

Abstract: A breakable capsule such as a seamless breakable capsule useful in a smoking article or a smokeless tobacco product includes an outer shell formed of a cross-linked agar matrix including at least one filler, and an inner core surrounded by the outer shell which comprises a liquid or gel based composition of a flavorant and/or non-flavorant. The cross-linked agar matrix is reinforced with carboxymethyl cellulose that is dispersed throughout the agar matrix so as to fill empty spaces in the agar matrix and inhibit the composition from passing through the empty spaces of the agar matrix.

Abstract: The present invention provides compositions and methods for treating a subject in need of treatment with testosterone, including introducing testosterone into the subject subcutaneously, intradermally, or intramuscularly, from a needle assisted jet injection device.

Abstract: A method for synchronizing ovulation in sows and gilts by a single injection of hormones is disclosed. A hormone, gonadotropin releasing hormone (GnRH), luteinizing hormone (LH), follicle stimulating hormone (FSH), human chorionic gonadotropin (hCG), analogues, derivatives, agonists or combinations thereof is administered to an open sow post weaning at a specific time to stimulate ovulation of mature responsive follicles. The sow is then bred, without heat detection, at a specific subsequent timed interval after injection with hormone, with one or two artificial or natural breedings. In gilts, the hormone is injected at a timed interval from onset of estrus or at a specific timed interval following Prostaglandin F2a for those gilts which have been held in a state of pseudopregnancy.

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: Method of diagnosis of IVF viability. The method includes ascertaining a subject's AMH level from testing and then selecting one pregnancy or live birth prognosis category that applies to the ascertained AMH level by matching the ascertained AMH level with an applicable one of a plurality of ranges of AMH levels pertaining to an age of the subject. The matching indicates the prognosis category that applies, i.e., (that is, good, intermediate or poor. In view of the diagnosis, a method of administration of AMH may be pursued to increase probability of pregnancy or live birth chances. Alternatively, the administration of AMH may be at AMH levels that will terminate pregnancy or increase the chance of miscarriage.

Abstract: Novel methods for treating or reducing the likelihood of acquiring symptoms or diseases due to the menopause, in postmenopausal women, particularly osteoporosis, vaginal atrophy and dryness, hypogonadism, diminished libido, skin atrophy, connective tissue disease, urinary incontinence, breast, endometrial, ovarian and uterine cancers, hot flashes, loss of muscle mass, insulin resistance, fatigue, loss of energy, aging, physical symptoms of menopause, in susceptible warm-blooded animals including humans involving administration of a sex steroid precursor are disclosed. Said method comprising novel ways of administering and dosing dehydroepiandrosterone (DHEA) in order to take advantage of positive androgenic effects in the vaginal layers lamina propia and/or the layer muscularis, without undesirably causing systemic estrogenic effects in order to avoid the risk of breast and uterine cancer. Pharmaceutical compositions for delivery of active ingredient(s) useful to the invention are also disclosed.

Abstract: It relates to an oil-in-water nanoemulsion composition having a continuous aqueous phase and dispersed oil droplets, wherein the nanoemulsion comprises: (a) clobetasol; (b) one or more oil components; and (c) one or more surfactants; together with one or more pharmaceutically acceptable excipients or carriers wherein: the osmolality of the nanoemulsion is comprised from 100 mOsm/Kg to 500 mOsm/Kg; the droplet average size measured by Dynamic light scattering is comprised from 1 nm to 500 nm; the weight ratio between the oil components and the sum of the oil components and one or more surfactants is comprised from 0.001 to 0.5; the weight ratio between the oil component and clobetasol is comprised from 1:1 to 200:1; and the weight ratio between the surfactant and clobetasol is comprised from 2:1 to 200:1. It also relates to processes for its preparation, its use as a medicament, and in the prophylaxis and/or treatment of inflammatory diseases or conditions.

Abstract: The present invention relates to compounds and methods which may be useful as treatments of diseases.

Abstract: Compounds are provided according to Formula (I): and pharmaceutically acceptable salts thereof, and pharmaceutical compositions thereof; wherein R1, R2, R3, and R6, R11a, and R11b are as defined herein. Compounds of the present invention are contemplated useful for the prevention and treatment of a variety of conditions.

Abstract: The present disclosure relates to novel pharmaceutical composition for the administration of testosterone or testosterone derivatives. The present disclosure also provides methods of treatment of diseases and disorders associated with fear and anxiety, a decrease in libido, or hypogonadism.

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: The present invention relates to the use of SHIP1 inhibitors and pan-SHIP1/2 inhibitors in various methods, including, without limitation, a method of inhibiting SHIP to induce broad activation of natural killer (NK) cells to treat various diseases.

Abstract: A method of promoting muscle growth consisting of providing a dietary supplement containing an effective amount of dehydroandrosterol to a user. A composition for promoting muscle growth containing an effective amount of dehydroandrosterol.

Abstract: The present disclosure provides high concentration formulations of cortexolone-17?-propionate suitable for treating alopecia.

Abstract: The present invention provides a composition comprising two or more of the following pharmaceutically active compounds: (i) an alpha 2 adrenergic agonist; (ii) a corticosteroid; (iii) a lymphocyte function-associated antigen antagonist; (iv) a non-steroidal anti-inflammatory drug (NSAID); (v) a sodium channel blocker; and (vi) an antibiotic, provided at least one of the pharmaceutically active compound is selected from the group consisting of (i) alpha 2 adrenergic agonist and (ii) corticosteroid.

Abstract: Novel methods for treating or reducing the likelihood of acquiring vaginal dysfunctions, more particularly vaginal dryness and dyspareunia, leading to sexual dysfunction and low sexual desire and performance, in susceptible warm-blooded animals including humans involving administration of a sex steroid precursor. Further administration of estrogen or selective estrogen receptor modulator, particularly those selected from the group consisting of Raloxifene, Arzoxifene, Tamoxifen, Droloxifene, Toremifene, Iodoxifene, GW 5638, TSE-424, ERA-923, and lasofoxifene, and more particularly compounds having the general structure: is specifically disclosed for the medical treatment and/or inhibition of development of some of these above-mentioned diseases. Pharmaceutical compositions for delivery of active ingredient(s) and kit(s) useful to the invention are also disclosed.

Abstract: A pharmaceutical hydrocortisone solution including at least hydrocortisone or a pharmaceutically-acceptable salt thereof, rongalite, disodium EDTA, and a solvent. Also relates to its use in the treatment of acute adrenal insufficiency and asthma. Also relates to an injection kit including an injection device and this pharmaceutical solution.

Abstract: The present invention relates generally to a combination for use in the treatment of gynaecological diseases and associated disabling symptoms thereof, in a subject in need thereof, said pharmaceutical combination for use comprising co-administering a suitable pharmaceutical composition for oral administration comprising a first progesterone receptor modulator and a pharmaceutical composition suitable for vaginal and/or intrauterine administration comprising a second progesterone receptor modulator.

Abstract: The present invention provides compositions and methods for treating a subject in need of treatment with testosterone, including introducing testosterone into the subject subcutaneously, intradermally, or intramuscularly, from a needle assisted jet injection device.

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: The present invention refers to a new enzymatic process for obtaining 17?-monoesters of cortexolone and/or its 9,11-dehydroderivatives starting from the corresponding 17?,21-diesters which comprises an enzymatic alcoholysis reaction. Furthermore, the present invention refers to new crystalline forms of cortexolone-17?-propionate and 9,11-dehydro-cortexolone 17?-butanoate.

Abstract: The present invention refers to a new enzymatic process for obtaining 17?-monoesters of cortexolone and/or its 9,11-dehydroderivatives starting from the corresponding 17?,21-diesters which comprises an enzymatic alcoholysis reaction. Furthermore, the present invention refers to new crystalline forms of cortexolone-17?-propionate and 9,11-dehydro-cortexolone 17?-butanoate.

Abstract: A cocrystalline DHEA composition with at least one additional coformer is disclosed for therapeutic formulations. The cocrystalline DHEA/coformer formulation including at least one coformer chosen from the group consisting of glutaric acid, maleic acid, tartaric acid, fructose, and wherein the L-isomer of tartaric acid and the D-isomer of fructose are utilized. The cocrystalline DHEA/coformer formulations include certain excipients as a solubilizer or inhibitor.

Abstract: The present invention relates to a tall oil fatty acid for use in the prevention of growth of harmful bacteria in the animal digestive tract and/or in the prevention of intestinal disorders. The invention further relates to a feed supplement and a feed composition comprising tall oil fatty acid.

Abstract: Novel methods for treating or reducing the likelihood of acquiring vaginal dysfunctions, more particularly vaginal dryness and dyspareunia, leading to sexual dysfunction and low sexual desire and performance, in susceptible warm-blooded animals including humans involving administration of a sex steroid precursor. Further administration of estrogen or selective estrogen receptor modulator, particularly those selected from the group consisting of Raloxifene, Arzoxifene, Tamoxifen, Droloxifene, Toremifene, Iodoxifene, GW 5638, TSE-424, ERA-923, and lasofoxifene, and more particularly compounds having the general structure: is specifically disclosed for the medical treatment and/or inhibition of development of some of these above-mentioned diseases. Pharmaceutical compositions for delivery of active ingredient(s) and kit(s) useful to the invention are also disclosed.

Abstract: The subject invention relates to a variety of formulations of bipolar trans carotenoids including pharmaceutical compositions for oral delivery of a bipolar trans carotenoid comprising i) a bipolar trans carotenoid, ii) a cyclodextrin, and iii) a coating. The invention also relates to preparation of such formulations and their uses.

Abstract: A method of diagnosing a subject's percentage of probability of retrieval of oocytes based on an age of the subject by selecting the percentage that matches the subject's AMR level in accord with plotted curves for retrieval of ?1, ?2, ?3, ?4 and ?5 oocytes and administering AMR to the subject, as warranted, to increase the AMR level to attain a desired percentage of probability of retrieval of oocytes based upon the age of the subject and in accord with a matching percentage for the increased AMR level from plotted curves for retrieval of ?1, ?2, ?3, ?4 and ?5 oocytes.

Abstract: The present application provides 17 and/or 21 esters of 17?,21-Dihydroxypregna-4,9(11)-diene-3,20-dione and 17?,21-dihydroxypregna-4-ene-3,20-dione having remarkable antiandrogenic activity, methods of using these compounds, and processes for their preparation.

Abstract: Described herein are nitrated lipids and methods of making and using the nitrated lipids.

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.

Abstract: The present invention relates to pharmaceutical compositions for a combination therapy with a corticosteroid and exosomes. By means of the combination therapy diseases such as osteoarthritis, arthritis and/or degenerative spinal diseases can be treated.

Abstract: The invention relates to a method for treating uterine fibroids, which method comprises administering to a patient in need thereof, an effective amount of 17?-acetoxy-11?-[4-N,N-dimethylamino-phenyl)-19-norpregna-4,9-diene-3,20-dione (ulipristal) or any metabolite thereof. More particularly, the method is useful for reducing or stopping bleeding in a patient afflicted with uterine fibroids, and/or for reducing the size of uterine fibroids.

Abstract: This invention relates the use of cortisol blockers (e.g., glucocorticoid receptor [GR] antagonists) for the treating or preventing viral infections, treating or preventing treatment resistant prostate cancer, treating or preventing neoplasia, and treating or preventing infection related to acute or chronic injury or disease.

Abstract: Endometriosis, including endometriosis externa, endometrioma, adenomyosis, adenomyomas, adenomyotic nodules of the uterosacral ligaments, and endometriotic nodules, such as scar endometriosis are effectively treated by the intralesional administration, including transvaginal, endoscopic or open surgical administration including via laparotomy, of a progestogen. Compositions therefor also are provided.