Abstract: The invention provides, in part, polyhydroxylated bile acids for treating biliary disorders, for example, biliary disorders arising out of cholestasis of portal hypertension. The invention also provides, in part, polyhydroxylated bile acids for stimulating bile flow. New compounds 2?,3?,7?,12?-tetrahydroxy-5?-cholanoic acid and 3?.4?,7?,12?-tetrahydroxy-5?-cholanoic acid are disclosed, uses thereof and synthesis thereof.

Abstract: The present invention relates to a pharmaceutical composition comprising micronized progesterone, soya bean lecithin, and at least one oil selected from the group consisting of sunflower oil, olive oil, sesame see oil, colza oil, almond oil, to the method for the preparation thereof and to the uses thereof for treating a physiological condition linked to insufficiency of progesterone secretion.

Abstract: Compositions and methods useful in the non-surgical removal of localized fat deposits in patients in need thereof using pharmacologically active detergents are disclosed. The pharmacologically active detergent compositions can additionally include anti-inflammatory agents, analgesics, dispersion agents and pharmaceutically acceptable excipients but do not contain phosphotidylcholine. The pharmacologically active detergent compositions are useful for treating localized accumulations of fat including lower eyelid fat herniation, lipodystrophy and fat deposits associated with cellulite and do not require surgical procedures such as liposuction.

Abstract: The present invention discloses an emergency contraceptive formulation for nasal and/or pulmonary administration comprising of levonorgestrel optionally in combination with ethylestradiol. The said formulation can be in form of solution, suspension or carrier based systems selected from microemulsion and liposomes.

Abstract: A neutral-fat-level-regulating agent, a cholesterol-level-regulating agent, a free-fatty-acid-level-regulating agent or an anti-obesity agent, including: at least one of protopanaxatriol, panaxatriol, protopanaxadiol and panaxadiol which are aglycons of dammarane-type saponins; and a hyperlipemia-ameliorating agent including: at least one of the neutral-fat-level-regulating agent, the cholesterol-level-regulating agent, the free-fatty-acid-level-regulating agent and the anti-obesity agent.

Abstract: A composition including: at least one mixture selected from the group consisting of a mixture of (A) panaxatriol and (B) protopanaxatriol and a mixture of (C) panaxadiol and (D) protopanaxadiol, wherein a ratio (A)/(B) of a mass of the (A) panaxatriol to a mass of the (B) protopanaxatriol is 1 or greater, and a ratio (C)/(D) of a mass of the (C) panaxadiol to a mass of the (D) protopanaxadiol is 1 or greater.

Abstract: The present invention provides ascending-dose extended cycle regimens in which a female is administered an estrogen and a progestin for a period of greater than 30 or 31 consecutive days, optionally followed by a hormone-free period or by a period of administration of estrogen. The disclosed regimens can be administered to a female to provide contraceptive and non-contraceptive benefits.

Abstract: A pharmaceutical preformulation in the form of a solid, free-flowing dry extract of a natural mixture of conjugated equine estrogens, which is particularly suitable use in for solid galenic forms, e.g. tabletting. The conjugated estrogens are available for further galenic processing in a form which assures the chemical stability of the hormones and permits advantageous processing into solid galenic forms, for example a tablet. The invention furthermore relates to a method for producing these preformulations in the form of a dry extract.

Abstract: Anti-inflammatory and antiallergic compounds of the glucocorticosteroid series according to formula (I) defined herein are useful for treating diseases of the respiratory tract characterized by airway obstruction.

Abstract: The present invention relates to a method for the prevention or treatment of certain breast cancers or ovarian cancer comprising administering to a patient in need thereof of a therapeutically effective amount of a 17,20-lyase inhibitor, wherein the breast cancer or ovarian cancer is estrogen receptor (ER) negative.

Abstract: Anti-inflammatory and antiallergic compounds of the glucocorticosteroid series, according to formula (I) according to formula (I) defined herein are useful for treating diseases of the respiratory tract characterized by airway obstruction.

Abstract: The invention relates to 17-hydroxy-13-methyl-17-pentafluoroethyl-11-acyloxyalkylenephenyldodecahydrocyclopenta[a]phenanthren-3-one derivatives 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: 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: A pharmaceutical composition comprising as a first active ingredient an estrogen, such as estradiol or estradiol valerate, in sufficient amounts to treat disorders and symptoms associated with deficient endogenous levels of estrogen in women, and as a second active ingredient 6?,7?;15?;16?-dimethylene-3-oxo-17?-preg-4-ene-21,17-carbolactone (drospirenone, DRSP) in sufficient amounts to protect the endometrium from the adverse effects of estrogen is useful for, amongst others, treating peri-menopausal, menopausal and post-menopausal women. This composition may be used for hormone replacement therapy and may be administered as a multi-phased pharmaceutical preparation. This combination therapy may comprise continuous, sequential or interrupted administration, or combinations thereof, of DRSP and estrogen, each optionally in micronized form.

Abstract: The present invention is directed to monophasic pharmaceutical compositions comprising a conjugated estrogen and a hydrophilic or lipophilic excipient. The present invention is also directed to kits and applicators comprising the pharmaceutical compositions. The invention is also directed to methods for treating menopausal conditions in a female comprising administration of the pharmaceutical compositions.

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.

Abstract: The present invention provides methods of inducing contraception which includes delivering to a female a composition containing a compound of formula I, or tautomers thereof, in a regimen which involves delivering one or more of a selective estrogen receptor modulator, wherein formula I is: and wherein R1-R5 and Q1 are defined as described herein. Methods of providing hormone replacement therapy and for treating carcinomas, dysfunctional bleeding, uterine leiomyomata, endometriosis, and polycystic ovary syndrome is provided which includes delivering a compound of formula I and a selective estrogen receptor modulator are also described.

Abstract: The present invention relates to a flexible extended use regimen for a hormonal contraceptive useful to manage bleeding problems associated with fixed extended use of hormonal contraceptives and to a pharmaceutical package containing the respective hormonal contraceptive.

Abstract: This invention relates to a low cost rapid response diagnostic system to determine cortisol levels in patients selected as potential candidates for GCR (glucocorticoid receptor) antagonist therapy utilizing a GCR antagonist, such as ORG 34517. The rapid, sensitive, and inexpensive test can be used to determine patients who have non-normal cortisol production or disordered circadian rhythms as a method for selecting subjects for GCR antagonist therapy for whom it is likely to have beneficial and/or therapeutic effects, and can also be used to monitor changes in cortisol levels in response to treatment.

Abstract: The present invention relates to a method of treating infertility in a female mammal that involves controlled ovarian hyperstimulation. The method includes administering to the female a combination of (i) an FSH substance in an amount effective to stimulate follicular development and (ii) a steroid in an effective amount to inhibit or suppress the secretion of luteinising hormone. The steroid can be substances represented by the following formula in which formula R1, R2, R3, R4 independently are a hydrogen atom, a hydroxyl group or an alkoxy group with 15 carbon atoms; each of R5, R6, R7 is a hydroxyl group; no more than 3 of R1, R2, R3, R4 are hydrogen atoms; derivatives of the aforementioned steroid substances; or mixtures of one or more of the aforementioned substances or derivatives.

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: 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 present invention is directed to non-effervescent, orally disintegrating solid pharmaceutical dosage forms comprising progestin and methods of making and using the dosage forms to treat conditions in females in need thereof.

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 present invention relates to improved glucocorticoid therapy and to treatment or prevention of a number of disorders that are due to a diminished or disrupted endogenous glucocorticoid secretory pattern. The invention is based on the findings that producing a specific serum Cortisol time profile that mimics the circadian rhythm of Cortisol of a healthy subject in a subject suffering from a diminished or disrupted glucocorticoid secretory pattern gives benefits with respect to reduction of side-effects.

Abstract: This disclosure concerns novel demethylpenclomedine analogs. Also disclosed are pharmaceutical compositions and methods for using such compositions to treat hyperproliferative disorders.

Abstract: The present invention provides compounds of formula (I) wherein n, p, R1, R2, X1, X2, X3, X4, X5, R3a, R3b, R4, R5 and R6 are as defined in the specification, a process for their preparation, pharmaceutical compositions containing them and their use in therapy.

Abstract: The present invention relates to a topical pharmaceutical composition that comprises the combination of an antimicrobial, a glucocorticoid, an antimycotic and pharmaceutically acceptable vehicles or excipients; the method for producing the composition and the use of said composition for treating localized dermatosis ailments.

Abstract: The present invention is directed to monophasic pharmaceutical compositions comprising a conjugated estrogen and a hydrophilic or lipophilic excipient. The present invention is also directed to kits and applicators comprising the pharmaceutical compositions. The invention is also directed to methods for treating menopausal conditions in a female comprising administration of the pharmaceutical compositions.

Abstract: A composition comprising an alcohol and an aloe vera gel for topically treating hot flashes and methods for the storing, dispensing and application thereof.

Abstract: A topical application formulation of estrogen and estrogen analogs or other estrogen receptor modulators is disclosed for the treatment of primary or secondary dry eye syndrome (also known as keratoconjunctivitis sicca (KCS)). Preferred formulations include 17-?-estradiol and its derivatives in lipid, liposomes, polymers, or aqueous or non-aqueous vehicles for the topical treatment of the ocular surface tissues particularly as time-release or micro-dose formulations. These formulations may also be useful in treating other conditions where KCS may occur, such as post-operative refractive surgery and corneal transplant patients.

Abstract: Methods for ameliorating a symptom associated with hypercholesterolemia, hyperlipidemia, or both in a subject. In some embodiments, the methods include administering to a subject in need thereof an effective amount of a composition comprising pregnenolone (PG), allopregnanolone (ALLO), dehydroepiandrosterone (DHEA), progesterone (PROG), precursors thereof, metabolites thereof, pharmaceutically acceptable salts thereof, derivatives thereof, or combinations thereof. Also provided are methods for ameliorating at least one symptom resulting from undesirable cholesterol biosynthesis in a subject and methods for lowering cholesterol, low density lipoprotein, or both in the serum of a subject.

Abstract: The present invention relates to methods of treating, preventing, or decreasing the occurrence of a condition characterized by Th2 overactivation or impaired Th1, or mitigating symptoms associated with a condition characterized by Th2 overactivation or impaired Th1, comprising orally administering to a subject in need thereof an effective amount of a composition comprising a plant stanol and/or plant stanol ester. The present invention also relates to methods of improving the health status of a subject suffering from asthma and increasing the levels of IL-10 in a subject in need thereof.

Abstract: The present invention relates to pharmaceutical compositions and kits comprising pharmaceutical compositions, and methods for administering pharmaceutical compositions comprising active contraceptive drugs in a patient. Specifically, the pharmaceutical compositions may comprise progestogen-only contraceptives (“POC”), such as Drospirenone.

Abstract: The present invention provides a pharmaceutical composition in the form of a water-based gel comprising: at least one pharmaceutically active compound; at least one gelling agent; a solubilising agent; and water, wherein said composition is free or substantially free of unsubstituted monohydric alcohols having between 1 and 6 carbon atoms. The invention also relates to methods for preparing the compositions and uses thereof.

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 particles comprising Drospirenone encapsulated in a polymer selected from the group consisting of glycolic acid polymer, lactic acid polymer, poly caprolactones, poly anhydrides and any copolymer of these, e.g., poly(lactic acid-co-glycolic acid) polymer and any combination of these. Furthermore, the present invention also relates to compositions comprising such particles. The present invention also relates to the use of such particles or compositions as contraceptives and for treatment of diseases, disorders and symptoms associated with deficient endogenous levels of estrogen in women.

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 relates to a flexible extended use regimen for a hormonal contraceptive useful to manage bleeding problems associated with fixed extended use of hormonal contraceptives and to a pharmaceutical package containing the respective hormonal contraceptive.

Abstract: The present invention provides slow release estradiol-progesterone formulations that can be used in either contraception or hormone replacement therapies. The formulations comprise shaped particles of estradiol that is in a hemicrystalline form that exhibits especially low dissolution rates. The shaped particles comprise estradiol compounded in a 1:1 molar ratio with cholesterol, and are administered in combination with progesterone. The slow release formulations of the present invention afford the dual advantages of a low dose estradiol formulation with a low frequency administration regimen. The formulations can be parenterally administered once a month or less often.

Abstract: The multiphase combination preparation for oral therapy of dysfunctional uterine bleeding and for oral contraception contains a first phase consisting of 2 daily dosage units, each containing 3 mg of estradiol valerate or <3 mg of estradiol; a second phase consisting of a first group of 5 daily dosage units, each consisting of a combination of 2 mg of dienogest with 2 mg of estradiol valerate or <2 mg of estradiol, and a second group consisting of 17 daily dosage units, each consisting of a combination of 3 mg of dienogest with 2 mg of estradiol valerate or <2 mg of estradiol; a third phase consisting of 2 daily dosage units, each containing 1 mg of estradiol valerate or <1 mg of estradiol; and another phase consisting of 2 daily dosage units of a pharmaceutically harmless placebos.

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 present invention relates to a pharmaceutical composition for inhalation. The invention is further directed to a method for setting the performance characteristics of such a pharmaceutical composition and the use of such a composition in the treatment of asthma, COPD, allergies, infectious diseases and diseases of the cardiovascular system.

Abstract: The present invention relates to a composition comprising Drospirenone dispersed in a liquid or semi-solid lipophilic vehicle. The present invention further relates to the use of such compositions as contraceptives and for treatment of diseases, disorders and symptoms associated with deficient endogenous levels of estrogen in women.

Abstract: The present invention relates to a veterinary zoo-technical drug delivery system (device) for the simultaneous release of two or more active substances, which system releases the active substances in a substantially constant ratio over a prolonged period of time. The drug delivery system can be in different forms, such as e.g. an implant, or a intravaginal device such as a helical coil, a spring or a ring.

Abstract: The present invention relates to a method for obtaining a natural mixture of conjugated estrogens from urine of pragnant mares (PMU) and use of a macroporous adsorption resin in the method. The method for obtaining a natural mixture of conjugated estrogen from PMU includes the steps of pretreating raw PMU; adsorbing the natural mixture of conjugated estrogens contained in PMU with a macroporous adsorption resin; washing the macroporous adsorption resin laden with the mixture of conjugated estrogens with an alkaline aqueous solution; and eluting the washed adsorption resin with an eluting agent to obtain the mixture of conjugated estrogens. The macroporous adsorption resin is a styrene-divinylbenzene semipolar macroporous adsorption resin with ester group structure. The method according to the invention solves the problems of low adsorptive capacity and high cost existed in the conventional methods, and is suitable for large-scale production.

Abstract: A multiphasic estrogenic/progestogenic contraceptive regimen that provides for the reduction or elimination of estrogen in the initial phase is disclosed. Also described is a contraceptive kit that may be used to practice the method of the invention.

Abstract: The invention relates to a method for the production of highly stable aqueous dispersions of phytosterols, phytostanols and derivatives thereof, which allows the use of a wide range of emulsifiers in relatively small concentrations in relation to the phytosterols and which allows the preparation of dispersions with high concentrations of phytosterols. Said dispersions are obtained using a method in which one or more phytosterols, an aqueous medium and one or more emulsifiers are dispersed in a disperser at a temperature of at least 140° C. in order to obtain an emulsion and the resulting emulsion is subsequently cooled in order to obtain a dispersion of sterols in an aqueous medium.

Abstract: An injectable preparation of estrogenic and progestrogenic hormonal compounds in an anhydrous excipient injected to synchronize estrus in non-menstruating placental female animals, and a five to nine day protocol to apply the unique preparation to achieve estrus synchronization.

Abstract: Compositions for treating cancers of mucosal tissues including breast, prostate, ovary, colon are disclosed which include various combinations of new or conventional anti-estrogen compounds, aromatase inhibitors, immune modulators, immune inhibitors, immune inhibitor mimicking compounds and steroid or thyroid hormones. Methods of predicting susceptibility of a cancer of mucosal origin to treatment with a composition containing an immune inhibitor or an immune inhibitor mimicking compound are also disclosed. Preferred methods include identifying in a specimen of cancer cells the presence of a Poly-Ig (Fc) receptor or Poly-Ig-like (Fc) receptor capable of binding to an immune inhibitor or an immune inhibitor mimicking compound and of mediating immune inhibition of cancer cell growth.