Abstract: The invention relates to the treatment of wrinkles in the face, wrinkles at open-necked regions, pregnancy strias, and stretched strias on the lower abdomen, thighs or buttocks with a steroidal aromatase inhibitor which also has 5-alpha reductase inhibitor activity which is 4-hydroxyandrostenedione or a derivative thereof.

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 is a method of remyelinating axons with 6-substituted estradiol compounds of the formula The methods can be used to treat a variety of demyelinating diseases.

Abstract: The invention refers to the use of androgen receptor antagonists for the treatment and/or prevention of fibroids, also known as uterine leiomyoma, leiomyomata. Particularly, the invention refers to the use of an androgen receptor antagonist being any one of the compounds according to the following list: cyproterone acetate, oxendolone, chlormadinone acetate, spironolactone, osaterone acetate, dienogest, flutamide, hydroxyflutamide, nilutamide, bicalutamide, RU 58841, LGD-2226, MDV3100, BMS-641988, BMS-779333, or 4-(3-{[6-(2-hydroxy-2-methylpropoxy)pyridin-3-yl]methyl}-4,4-dimethyl-5-oxo-2-thioxoimidazolidin-1-yl)-2-(trifluoromethyl)benzonitrile (thioxoimidazolidine derivative) for the treatment of fibroids.

Abstract: Methods for treating neurodegeneration and/or myelination in patients are disclosed comprising treating the patient with a progestin compound which exerts binding to progesterone receptors and elicits progesterone-receptor-induced biological responses without interacting with the androgen receptor and without inducing androgen or glucocorticoid biological responses at a dosage sufficient to prevent or reduce neurodegeneration. The progestin compound preferably comprises 16-methylene-17?-acetoxy-19-norpregn-4-ene-3,20-dione, and the methods include combining the progestin compound with an estrogen compound to provide both contraception and treatment for myelin repair and neurodegeneration.

Abstract: Disclosed herein are nanofilm coatings for implantable medical devices comprising a diblock or triblock copolymer (PEO-PMMA or PMOXA-PDMS-PMOXA, respectively). Such nanofilms, may be used, for example, as amphiphilic supports for therapeutic agents. These materials are conducive towards the formation of active substrates for a suite of biological and medical applications.

Abstract: This invention is related to pharmaceutical compositions consisting of charged micelles containing bioactive agents. The invention is also related to the methods of delivery of charged micelles to the eye of a mammal by iontophoresis.

Abstract: This invention pertains to the use of steroid compounds including spirosteroid analogues in treating, preventing or ameliorating the symptoms of inflammatory conditions. The steroid compounds are useful for treating a range of inflammatory conditions, including, but not limited to asthma, lung inflammation, retinal inflammatory conditions, autoimmune diseases such as rheumatoid arthritis, diabetes type I, systemic lupus erythematosus, ulcerative colitis and inflammatory bowel diseases and myopathies, as well as multiple sclerosis. The active compounds are represented by Formula I: wherein R1, R2, R3, R4, R5, R6, R7, A, B, X, Y and Z are defined in the description of the invention.

Abstract: Compositions, products and methods including silicone based excipients are provided. The compositions, products and methods of the present invention are particularly useful for the treatment of ophthalmic diseases.

Abstract: The present invention relates to novel uses of C-19 steroid compounds, in particular C-19 steroids having an androsten-17-(OR4)-3-one structure for cosmetic and further uses, wherein R4 is hydrogen or an unsubstituted or substituted alkyl, aryl, acyl or any group leading to hydroxyl upon biological metabolization or chemical deprotection. The present invention particularly relates to selected C-19 steroids displaying properties of high binding affinity to androgen receptor to block dihydrotestosterone from binding, while at the same time providing anabolic effects, which is useful for certain applications, particularly for influencing or controlling problems of the skin and its skin-associated body structures like cellulite, wrinkles, adipose fat tissues, hair follicles or hair growth; for influencing or controlling gland function and activity such as the sebaceous gland and other glands affecting the skin and/or perspiration.

Abstract: A stabilized bioadhesive composition containing an alkaline labile drug and a method for its preparation are provided. In one aspect, the composition is a hot-melt extruded (HME) composition comprising a preformed excipient mixture comprising an acidic component and an alkaline thermoplastic matrix-forming material, e.g. polymer. The excipient mixture is formed before blending with an alkaline labile drug. The blend is then hot-melt extruded to form the HME composition. By so doing, the acidic component is able to neutralize or render moderately acidic the excipient mixture. This particular process has been shown to substantially reduce the degradation of an alkaline labile drug during hot-melt extrusion. The excipient mixture softens or melts during hot-melt extrusion. It can dissolve or not dissolve drug-containing particles during extrusion.

Abstract: The application provides formulations for the topical administration of an active agent comprising at least one steroid, in the form of topical sprays that are propellant-free, and/or substantially non-foaming, and/or alcohol-free. The present application also provides processes for preparing such compositions and methods of using them in management of skin diseases or disorders such as psoriasis, dermatoses, and other associated skin diseases or disorders.

Abstract: Compositions useful for inducing bone growth or inhibiting bone loss in an animal comprising one or more isoflavones or isoflavone metabolites and methods for inducing bone growth or inhibiting bone loss in an animal utilizing such compositions. The compositions and methods are particularly useful for post-menopause, post-andropause, gonadectomized, spayed, or neutered animals.

Abstract: The disclosure provides methods of treating bipolar disorder by administering an antiestrogen to reduce the severity and frequency of mood episodes. The disclosure further provides methods of treating depression with an antiestrogen in a descending dose protocol.

Abstract: Compositions and methods for inducing the deposition of elastin in skin by administering compositions including a mineralocorticoid, such as, for example, aldosterone and, optionally, a secondary active agent for enhancing or modulating the effect of the mineralocorticoid are described herein.

Abstract: The present invention comprises a composition, method of enhancing potency and method of delivering corticosteroids in a vehicle comprising at least two penetration enhancers, and solvents and emulsifiers. The propylene glycol and penetration enhancers are present in ratio to the total of the propylene glycol, penetration enhancers, and solvents and emulsifiers of at least about 0.70.

Abstract: The disclosure provides compositions for treating an ocular condition. The composition comprises a physiologically effective amount of an androgen, wherein the composition is suitable for topical administration to an eye. The disclosure further provides methods for treating an ocular condition with the disclosed compositions.

Abstract: The invention relates to pharmaceutical compositions comprising propylene glycol solvates of APIs.

Abstract: The present invention relates to the use of a combination of a PDE5-inhibitor and testosterone for the preparation of a medicament for the treatment of Female Sexual Dysfunction.

Abstract: Novel estrogenic compounds of Formula I are provided. wherein the bond represented by the wavy line may be a single or double bond such that when the wavy line is a single bond, R1 is selected from the group consisting of hydrogen, sulfate and glucoronate or other esters, and when the wavy line is a double bond, R1 does not exist; R2 is lower alkyl; R3 may be selected from the group consisting of hydrogen, sulfate, or glucuronide or other esters; and R4 through R13 may independently be selected from the group consisting of hydrogen, hydroxy, ketone, lower alkyl, lower alkoxy, halogen, and carbonyl groups and R14 is selected from the group consisting of hydrogen, sulfate and glucoronide and other esters. When R1 is hydroxy, the hydroxy or ester substituent may have either an ? or a ? orientation. Compositions of matter including compounds of the present invention are also provided as are methods of treating mammals in need of treatment using compounds of the present invention.

Abstract: The invention relates to 17-hydroxy-17-pentafluoroethylestra-4,9(10)-diene-11-methyleneoxyalkylenearyl derivative of the formula I with progesterone-antagonising action and to processes for preparation thereof, to use thereof for treatment and/or prophylaxis of disorders and to the use thereof for production of medicaments for treatment and/or prophylaxis of disorders, especially of fibroids of the uterus (myomas, uterine leiomyomas), endometriosis, heavy menstrual bleeds, meningiomas, hormone-dependent breast cancers and complaints associated with the menopause, or for fertility control and emergency contraception.

Abstract: The invention relates to methods identify or characterize compounds that can be used to treat specified clinical disorders such as hyperglycemia and type 2 diabetes. Compounds that can be used in these methods include 4?-fluoro-17?-ethynylandrost-5-ene-3?,7?,17?-triol, 4?-fluoro-17?-ethynylandrost-5-ene-3?,7?,17?-triol, 4?-fluoro-17?-ethynylandrost-5-ene-3?,7?,17?-triol and 4?-fluoro-17?-ethynylandrost-5-ene-3?,17?-triol-7-one.

Abstract: Provided are methods for aiding in diagnosing autoimmune diseases in a mammal, comprising contacting a sample of tear from the mammal with an antibody that specifically binds to a first polypeptide selected from the group Ctss, Ctsh, Ctsr, Ctsw, Ctsz, Ifng, Il16ra, Il10, Il10ra, Il15, Tnfa, Apo-F, or Lcn-2 or a second polypeptide selected from the group lactoperoxidase, lactoferrin or lysozyme under conditions favoring the formation of an antibody-polypeptide complex, and determining the amount of complex formed, wherein an increased formation of antibody-first-polypeptide complex or a decreased formation of antibody-second-polypeptide complex as compared to a suitable control, indicates a likely positive diagnosis of an autoimmune disease for the mammal, thereby aiding in the diagnosis. Methods of treating the autoimmune diseases are also provided.

Abstract: There is provided use of a cyclic compound or a pharmaceutically active salt thereof in the manufacture of a medicament to prevent and/or inhibit and/or arrest cell cycling, wherein the cyclic compound comprises at least one ring, wherein Group I and Group II, independently of each other, are attached to a ring of the cyclic compound; wherein Group I is a hydrocarbyl or an oxyhydrocarbyl group; and wherein Group II is a group of the formula X is P or S; when X is P, Y is ?O or S, Z is —OH and R is hydrocarbyl or H; when X is S, Y is ?O, Z is ?O, and R is hydrocarbyl or N(R1)(R2), wherein each of R1 and R2 is independently selected from H or a hydrocarbyl group.

Abstract: The present invention relates to a pharmaceutical composition in the form of a hydro-alcoholic gel or a solution for transdermal application, comprising: from about 0.2% to about 1.5% of dihydrotestosterone; and from about 0.2 to about 3% of isopropyl myristate.

Abstract: A polymer capsule manufactured by polymerizing a compound represented by Formula 1, or polymerizing the compound of Formula 1 and a compound of Formula 2, wherein a detailed structure of the compounds of Formulae 1 and 2 is presented in the detailed description.

Abstract: Novel etiology underlying certain types of seizures and migraines is presented, whereby changes in endocrine levels result in changes in osteoclast activity levels which in turn result in elevated extracellular Ca2+ levels which in turn result in systemic alterations in nerves muscles, including increased nerve membrane depolarization, enhanced calcium channel mediated neurotransmitter release, and increased muscle contractility via sarcoplasmic reticulum calcium release channel mediated tropomyosin block removal, which in turn result in increased seizure risk in people with low seizure thresholds. Treatment methods are provided that modulate the bone microenvironment to provide an etiology based seizure treatment method that simultaneously reduces nerve sensitivity and muscle contractility. Preferred embodiments include use of SERMs such as raloxifene, testosterone, estrogen, calcimimetics such as cinacalcet, RANKL inhibitors such as denosumab, and bisphosphonate such as risedronate.

Abstract: This present invention disclosed the use of mesoprogestins, a new class of progesterone receptor modulators (PRMs), for the treatment and prevention of benign hormone dependent gynecological disorders: a) for the treatment of gynecological disorder such as endometriosis, uterine fibroids, postoperative peritoneal adhesions, dysfunctional bleeding (metrorrhagia, menorrhagia) and dysmenorrhea; b) for the prevention of gynecological disorders such as postoperative, peritoneal adhesions, dysfunctional uterine bleeding (metrorrhagia, menorrhagia) and dysmenorrhea; and c) a method of treatment and prevention of the above mentioned disorders in a female, preferably in a human female, in need of treatment or prevention of one or more of these disorders, with an effective amount of a mesoprogestin. Mesoprogestins are defined as compounds possessing both agonistic and antagonistic activities at the progesterone receptor (PR) in vivo.

Abstract: The present disclosure is drawn to pharmaceutical compositions and oral dosage capsules containing testosterone undecanoate, as well as related methods of treatment. In one embodiment, the present invention provides for a pharmaceutical composition that includes a therapeutically effective amount of testosterone undecanoate and a solubilizer. The testosterone undecanoate is solubilized in the composition and is present in an amount such that it comprises about 14 wt % to about 35 wt % of the total composition.

Abstract: Nanonized formulations of testosterone esters, especially testosterone undecanoate, and of testosterone are prepared which show an enhanced oral bioavailability compared to the existing oral products on the market. The drug is dissolved in a melted lipid phase, which is subsequently nanonized. The drug is associated with the lipid. The drug can also be nanonized without having lipid present yielding nanocrystals. The nanonized drug can be incorporated into tablets or capsules for oral administration, typically one unit is sufficient for delivery of a single dose.

Abstract: A method for hormonal contraception comprising administering at least one contraceptive hormone in a plurality of linked taking periods optionally having a sequence lasting several years. Each taking period comprises at least one taking cycle. Each taking cycle comprises a duration-constant taking phase lasting several days and a taking pause lasting several days. In each taking phase the hormonal component is administrated in a daily unit. In each taking pause either a placebo or no unit is administered. The duration of the taking phase or phases of at least the final taking period is at least 22 days. The duration of each taking phase in any taking period preceding a following taking period is shorter than that in each of the taking phases in each following taking period.

Abstract: The invention relates to a method of reducing chronic inflammatory pain in a human subject with androgen deficiency symptoms comprising transdermally administering a pain-reducing amount of a composition comprising a bioactive androgen to the subject on a daily basis. The invention relates to a method of increasing the pain threshold of a human subject having symptoms of androgen deficiency comprising transdermally administering a composition comprising a pain threshold-increasing amount of a bioactive androgen to the subject with androgen deficiency symptoms on a daily basis. The invention may be used to treat males and females in order to alleviate chronic inflammatory pain or to raise the subject's pain threshold. The invention also relates to increasing the levels of endogenous opioid peptides in a human subject by administering an androgen composition to the subject.

Abstract: The present invention is directed generally to pharmaceutical compositions, methods, and kits for improving side effects associated with aromatase inhibitor treatment in a subject diagnosed with breast cancer. More specifically, the present invention provides compositions, methods, and kits comprising an aromatase inhibitor and an androgenic agent.

Abstract: The present invention relates to a novel pharmaceutical composition for transdermal or transmucous administration of at least one active substance, and comprising especially a fatty acid as a percutaneous absorption promoter, at least one alcoholic vehicle and also a stabilizer capable of stabilizing the fatty acid in the said pharmaceutical composition.

Abstract: The invention relates to a method for on-demand contraception, which method comprises administering a progestogen agent or progesterone receptor modulator, such as 17a-acetoxy-11b-[4-N,N-dimethylamino-phenyl)-19-norpregna-4,9-diene-3,20-dione (ulipristal acetate) in a woman, within 72 hours before an intercourse or within 120 hours after the intercourse.

Abstract: A nanosphere or microsphere drug carrier, formulations comprising the drug carrier and the preparation method of the formulations and the use of the carrier are disclosed. The carrier comprises a biodegradable methoxy end-capped polyethylene glycol-polylactide block copolymersor a derivative thereof represented by formula (I) as the main carrier material: CH3O—[CH2—CH2—O]m—[C(O)—CH(CH3)—O]n—R (I).

Abstract: The present invention provides a method for preparing a sterile suspension of a glucocorticosteroid. The glucocorticosteroids used in the invention are preferably antiinflammatory glucocorticosteroids. By making the last stage of product preparation be the sterilization process, the potential for contamination during manufacture and heat degradation of products is greatly reduced.

Abstract: The invention relates to a method of using ulipristal acetate or a metabolite thereof for providing contraception or for treating a patient's condition, comprising providing a patient with ulipristal acetate or a metabolite thereof, and informing the patient or a medical care worker that ulipristal acetate or a metabolite thereof affects activity of a cytochrome p450 isozyme, and that administration of ulipristal acetate or a metabolite thereof with a substance that affects activity of a cytochrome p450 isozyme can affect plasma concentration, safety, efficacy or any combination thereof of ulipristal acetate or a metabolite thereof, the substance, or both.

Abstract: Topical ophthalmic and otic solution compositions of moxifloxacin and dexamethasone phosphate are disclosed.

Abstract: A compound having the structure: wherein R1, R2, R, R, X, Y and Z are as defined herein. The compounds are estrogen receptor modulators useful for the treatment of proliferative disorders.

Abstract: A method of preventing estrogen deficiencies and osteoporosis in menopausal women by continuously orally administering without interruption to menopausal women in need thereof an amount of 0.3 to 3 mg of 17?-estradiol or esters thereof and 0.3 to 1.25 mg of nomegestrol or esters thereof in an amount sufficient to prevent said problems.

Abstract: The present invention is directed to nanoparticulate compositions comprising megestrol. The megestrol particles of the composition have an effective average particle size of less than about 2000 nm.

Abstract: A composition comprising a glassified, stabilized particle preparation having a low water activity (between about 0.1 and 0.9) is provided. The preparations provide improved products with enhanced storage stability, less expensive cost of processing, and extended shelf life. The glassified, stabilized particle preparations are particularly efficacious in the preparation of perishable products, especially pharmaceutical agents, such as human blood and blood products (e.g., red blood cells). A single emulsion process comprising a 2-phase system for preserving food and pharmaceutical products is also provided. Stabilized biological products as glassified beads are also provided, as well as a method for rehydrating and/or reconstituting the glassified beads to provide useful and fully active reconstituted and/or rehydrated materials is also presented.

Abstract: This invention relates to a pernasally administrable preparation for the controlled release of sexual hormones to the systemic circulation, in particular to a formulation which enables its active ingredient to be absorbed in a sustained manner providing a better bioavailability at very low doses and longer duration of action.

Abstract: Bone targeted compounds and methods are provided. Compounds can include a Bone Targeting Portion (RT), having an affinity for bone; a Bone Active Portion (RA) for interacting with and affecting bone; and a Linking Portion (RL) connecting the Bone Targeting Portion and the Bone Active Portion.

Abstract: The invention relates to pharmaceutical formulations, in particular to transdermal therapeutic systems, which are characterized in that little or no active ingredient crystallizes out at the interface between the removable protective film (release liner) and the active-ingredient-containing matrix.

Abstract: The invention provides the novel use of 20(S)-protopanaxadiol in the preparation of medicaments for the treatment of depressive psychiatric disorders. The pharmacological test results indicated that the compound could remarkably increase the level of NE, 5-HT and HAV in the brains of model rats having depressive disorders, remarkably enhance tremors induced by 5-hydroxytryptophan (5-HTP) and behavioral effects induced by levodopa, and inhibit the re-uptake of 5-HT and NA.

Abstract: 17?,21-Dihydroxypregna-4,9-diene-3,20-dione and 17?,21-dihydroxypregna-4-ene-3,20-dione 17 and/or 21 esters of having remarkable antiandrogenic activity, and the processes for the preparation thereof.

Abstract: The invention provides methods to treating conditions such as prostate cancer, or for ameliorating one or more symptoms associated with prostate cancer, or for agents that modulate the biological activity of the androgen receptor. The invention also provides methods and compositions suitable for therapeutic applications.

Abstract: Use of compounds disclosed herein, typically progesterone or analog or derivative thereof, in the treatment of central nervous system cancers, specifically neuroblastoma and glioblastoma is provided. The treatment offers a reduced toxicity as compared to the currently available chemotherapeutic agents. The progesterone may be administered alone or in combination with, or in conjunction with other therapeutic agents.