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.

Described herein are formulations of a somatostatin modulator, methods of making such formulations, and methods of using such formulations in the treatment of conditions, diseases, or disorders that would benefit from modulation of somatostatin activity.

GnRH receptor antagonists are disclosed which have utility in the treatment of a variety of sex-hormone related conditions in both men and women. The compounds of this invention have the structure: ##STR00001##
wherein R.sub.1a, R.sub.1b, R.sub.1c, R.sub.1d, R.sub.2, R.sub.2a, and A are as defined herein, including stereoisomers, esters, solvates and pharmaceutically acceptable salts thereof. Also disclosed are compositions containing a compound of this invention in combination with a pharmaceutically acceptable carrier, as well as methods relating to the use thereof for antagonizing gonadotropin-releasing hormone in a subject in need thereof.

The present invention relates to novel injectable presentations, kits or syringes comprising a composition with sustained or controlled release of lanreotide or one of the salts thereof. The compositions of lanreotide or one of the salts thereof are packaged in a syringe having a diameter greater than 3.00 mm and provided with a needle having an outer diameter no greater than 1.00 mm.

The present invention relates to novel injectable presentations, kits or syringes comprising a composition with sustained or controlled release of lanreotide or one of the salts thereof. The compositions of lanreotide or one of the salts thereof are packaged in a syringe having a diameter greater than 3.00 mm and provided with a needle having an outer diameter no greater than 1.00 mm.

A process may allow the preparation of one or more viscous pharmaceutical formulations and an apparatus may be configured for implementing such a process. A gellable material may be introduced into one chamber, a vehicle may be introduced in the other and by alternately applying force to each chamber, mixing and homogenization may take place. The internal diameter of the connection equipment of the two chambers may be equal to the outlet internal diameters of the chambers. Each chamber may have different diameter, with the first chamber being larger than the second chamber, so as to allow the process to be executed in a simple and more convenient manner.

Embodiments of the present invention provide a pharmaceutical intervention in the neonatal to infantile ruminants that inhibits the activation of the HPG axis, growth of the testis and inhibits testicular production of testosterone, which prevent the development of aggressive behavior in the maturing males and the presence of male-specific odor in the meat. The invention comprises treatment with an estrogen or a combination of an estrogen and an androgen in the newborn males using extended drug delivery methods, with a defined duration of no more than 1-4 months or infantile period of growth, for the purpose of inhibiting the production of testosterone and the accumulation of male-specific odor. The drug delivery component may consist of biocompatible-/biodegradable polymers in the form of pellets, microspheres, or gels, or in solvents or solutions (hereafter, drug complex). The invention embodies neonatal/infantile period treatment with a drug complex consisting of a hormone-based compound configured to inhibit development and function of hypothalamic Kisspeptin neurons, pituitary release of luteinizing hormone and postnatal development of the testis through the use of sustained but temporary release of the compounds into the body of an animal once the drug-carrier has been injected or implanted therein.

Embodiments of the present invention provide a pharmaceutical intervention in the neonatal to infantile ruminants that inhibits the activation of the HPG axis, growth of the testis and inhibits testicular production of testosterone, which prevent the development of aggressive behavior in the maturing males and the presence of male-specific odor in the meat. The invention comprises treatment with an estrogen or a combination of an estrogen and an androgen in the newborn males using extended drug delivery methods, with a defined duration of no more than 1-4 months or infantile period of growth, for the purpose of inhibiting the production of testosterone and the accumulation of male-specific odor. The drug delivery component may consist of biocompatible-/biodegradable polymers in the form of pellets, microspheres, or gels, or in solvents or solutions (hereafter, drug complex). The invention embodies neonatal/infantile period treatment with a drug complex consisting of a hormone-based compound configured to inhibit development and function of hypothalamic Kisspeptin neurons, pituitary release of luteinizing hormone and postnatal development of the testis through the use of sustained but temporary release of the compounds into the body of an animal once the drug-carrier has been injected or implanted therein.

The pharmaceutical compositions described herein include a suspension which comprises an admixture in solid form of a therapeutically effective amount of a therapeutic agent and at least one salt of a medium chain fatty acid and a hydrophobic medium, e.g. castor oil or glyceryl tricaprylate or a mixture thereof. The pharmaceutical compositions described herein contain medium chain fatty acid salts and are substantially free of alcohols. The pharmaceutical compositions may be encapsulated in a capsule. Methods of treating or preventing diseases by administering such compositions to affected subjects are also disclosed.

A pharmaceutical composition comprises octreotide acetate microparticles of linear poly (lactide-co-glycolide) polymer wherein the polymer contains less than 1% silicone oil or heptane.