Methods and compositions are provided for treatment of disorders associated with aberrant adrenal cortex cell behavior, including (but not limited to) treatment of adrenocortical carcinoma (ACC), Cushing's syndrome and/or pituitary ACTH excess (Cushing's Disease). Such methods involve administration of an effective amount N-(2,6-bis(1-methylethyl)phenyl)-N′-((1-(4-(dimethylamino)phenyl)cyclopentyl)-methyl)urea hydrochloride to the patient.

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.

Separable microneedle arrays and microneedle patches are provided that may achieve sustained release of drug. The microneedle arrays may include one or more features that facilitate separation of the microneedles, such as a bubble structure. The microneedle arrays may include an effervescent material.

The disclosed subject matter provides certain polymorphic forms of Compound (I) as well as pharmaceutical compositions comprising Compound (I) or such polymorphic forms, and methods of using or making such compounds and pharmaceutical compositions. It has now been discovered that Compound (I) can exist in multiple crystalline forms (polymorphs). One particular crystalline form, Form II, has been found to be more thermodynamically stable and, thus, likely more suitable for bulk preparation and handling than other polymorphic forms. Efficient and economic methods have been developed to prepare Compound (I) and Form II in high purity on a large scale. In animal studies, Form II has demonstrated safety and efficacy in treating depressive disorders and, when micronized, improved absorption compared to non-micronized Form II.

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The present invention relates to: a novel Lactobacillus intestinalis YT2 strain (deposition number: KCCM11812P); and a composition for preventing, alleviating, or treating menopause, comprising, as an active ingredient, Lactobacillus intestinalis comprising the novel strain. The present inventors have established an animal model for menopause through ovariectomy, confirmed changes of the distribution of intestinal microorganisms by the model, identified and isolated a novel Lactobacillus intestinalis strain among lactic acid bacteria of which the distribution is significantly reduced in the menopausal model, and confirmed effects, by means of the novel strain and previously reported Lactobacillus intestinalis strains, of alleviating menopausal symptoms, such as the inhibition of an increase in body fat, the inhibition of a decrease in bone mineral density, the inhibition of an increase in the pain sensitivity, and the alleviation of depression. Therefore, it is expected that the composition comprising the Lactobacillus intestinalis according to the present invention can be usable for a use of preventing, alleviating, or treating menopause.

The present invention relates to: a novel Lactobacillus intestinalis YT2 strain (deposition number: KCCM11812P); and a composition for preventing, alleviating, or treating menopause, comprising, as an active ingredient, Lactobacillus intestinalis comprising the novel strain. The present inventors have established an animal model for menopause through ovariectomy, confirmed changes of the distribution of intestinal microorganisms by the model, identified and isolated a novel Lactobacillus intestinalis strain among lactic acid bacteria of which the distribution is significantly reduced in the menopausal model, and confirmed effects, by means of the novel strain and previously reported Lactobacillus intestinalis strains, of alleviating menopausal symptoms, such as the inhibition of an increase in body fat, the inhibition of a decrease in bone mineral density, the inhibition of an increase in the pain sensitivity, and the alleviation of depression. Therefore, it is expected that the composition comprising the Lactobacillus intestinalis according to the present invention can be usable for a use of preventing, alleviating, or treating menopause.

Novel microsphere compositions for use in parenteral formulations are provided. The microspheres comprise a biodegradable polymer of a molecular weight greater than 10,000 daltons, an active therapeutic agent, and a cellulose-derived material such as ethyl cellulose, carboxymethyl cellulose, hydroxypropylmethyl cellulose, or sodium carboxymethyl cellulose. The microsphere compositions decreased deviation in mean microsphere diameter, improved drug entrapment, and improved microsphere stability.

Novel microsphere compositions for use in parenteral formulations are provided. The microspheres comprise a biodegradable polymer of a molecular weight greater than 10,000 daltons, an active therapeutic agent, and a cellulose-derived material such as ethyl cellulose, carboxymethyl cellulose, hydroxypropylmethyl cellulose, or sodium carboxymethyl cellulose. The microsphere compositions decreased deviation in mean microsphere diameter, improved drug entrapment, and improved microsphere stability.

The present invention relates to pharmaceutical compositions for the treatment or prevention of symptoms associated with endocrine disturbances, such as hot flashes. The pharmaceutical compositions comprise a tricyclic amino containing compound of formula (I), such as MSX-122 (also known as “Q-122”) (N,N′-(1,4-phenylenebis(methylene))bis(pyrimidin-2-amine)), and one or more pharmaceutically acceptable excipients. The pharmaceutical compositions may be given in certain doses and/or dosing regimens, preferably twice daily.

Pharmaceutical compositions of the invention comprise functionalized lactone derivatives having a disease-modifying action in the treatment of diseases associated with dysregulation of 5-hydroxytryptamine receptor 7 activity.