Abstract: The disclosure generally relates to tamper-resistant transdermal dosage forms. The dosage forms can comprise an active agent and more than one antagonist reservoir.

Abstract: The present invention includes methods for preventing endometrial hyperplasia associated with estrogen therapy through the administration of a progestin agent. The methods presented may include starting the administration of a progestin agent at a high dose, and then lowering the dose.

Abstract: The present invention is directed to non-effervescent, orally disintegrating dosage forms comprising free base clozapine that are substantially free of acids, water-soluble polymers, taste-masking polymers, and coatings, and methods of making and using the same.

Abstract: The present invention includes methods for preventing endometrial hyperplasia associated with estrogen therapy through the administration of a progestin agent. The methods presented may include starting the administration of a progestin agent at a high dose, and then lowering the dose.

Abstract: The present invention includes methods for preventing endometrial hyperplasia associated with estrogen therapy through the administration of a progestin agent. The methods presented may include starting the administration of a progestin agent at a high dose, and then lowering the dose.

Abstract: An ondansetron solid orally disintegrating dosage form for oral administration having at least one first water-dispersible component or water-insoluble cellulose derivative, a component having a —CHOH functional group, a disintegrating agent and at least one lubricant is provided. The dosage form can comprise ondansetron, a hydrophilic polymer such as microcrystalline cellulose, a component having a —CHOH functional group such as mannitol or xylitol and a disintegrating agent such as crospovidone. The lubricant may be a mixture of magnesium stearate, sodium stearyl fumarate and colloidal silicon dioxide. The present invention provides a non-effervescent tablet comprising the ondansetron dosage form. Another aspect of the invention is the treatment of emesis such as nausea and vomiting caused by cancer chemotherapy and radiation by the administration of the ondansetron formulation of the present composition.

Abstract: The present invention relates to processes for the production of 2-oxa-3-one androstane derivatives. The processes comprise reacting a 3-one androstane derivative with ozone to form a 2-oxa-3-one androstane derivative.

Abstract: The present invention is generally directed to pharmaceutical compositions and process for the preparation of same which are suitable for oral administration to a human patient, comprising: a pharmaceutically-acceptable salt of 4-amino-1-hydroxybutylidene-1,1-bisphosphonic acid; a non-reducing sugar diluent; a binder; a disintegrant; and a lubricant, and various other excipients.

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 allyl, 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 relates to a process for the synthesis of oxandrolone from mestanolone. The process comprises the steps of: (a) oxidizing mestanolone to form 17?-hydroxy-17?-methyl-5?-androst-1-en-3-one; (b) hydroxylating the 17?-hydroxy-17?-methyl-5?-androst-1-en-3-one to form 1?, 2?, 17?-trihydroxy-17?-methylandrostan-3-one; (c) cleaving the 1?, 2?, 17?-trihydroxy-17?-methylandrostan-3-one to form 17?-hydroxy-17?-methyl-1-oxo-1,2,-seco-A-nor-5?-androstan-2-oic acid; and (d) reducing the 17?-hydroxy-17?-methyl-1-oxo-1,2,-seco-A-nor-5?-androstan-2-oic acid to form oxandrolone.

Abstract: The present invention relates to novel estrogenic compounds. The present invention also relates to methods of treating estrogen deprivation in a subject comprising administering novel estrogenic compounds. Additionally, the present invention relates to methods of synthesizing novel estrogenic compounds.

Abstract: The present invention is directed to solid oral dosage forms comprising surface-treated particles comprising modafinil particles and a hydrophilic treating agent, methods of making the same, and uses thereof

Abstract: The present invention is directed towards a kit to accompany a supply of a long-term use pharmaceutical. The kit includes at least a supply of a long-term use pharmaceutical, printed matter, and a pre-recorded media device. The kit may also include a planner and a reminder tool. The present invention also includes a container for storing at least the supply of the long-term use pharmaceutical, the printed matter, and the pre-recorded media device.

Abstract: The present invention relates to a process for the synthesis of oxandrolone from mestanolone. The process comprises the steps of: (a) oxidizing mestanolone to form 17&bgr;-hydroxy-17&agr;-methyl-5&agr;-androst-1-en-3-one; (b) hydroxylating the 17&bgr;-hydroxy-17&agr;-methyl-5&agr;-androst-1-en-3-one to form 1&agr;, 2&agr;, 17&bgr;-trihydroxy-17&agr;-methylandrostan-3-one; (c) cleaving the 1&agr;, 2&agr;, 17&bgr;-trihydroxy-17&agr;-methylandrostan-3-one to form 17&bgr;-hydroxy-17&agr;-methyl-1-oxo-1,2,-seco-A-nor-5&agr;-androstan-2-oic acid; and (d) reducing the 17&bgr;-hydroxy-17&agr;-methyl-1-oxo-1,2,-seco-A-nor-5&agr;-androstan-2-oic acid to form oxandrolone.

Abstract: The present invention is generally directed to pharmaceutical compositions and process for the preparation of same which are suitable for oral administration to a human patient, comprising: a pharmaceutically-acceptable salt of 4-amino-1-hydroxybutylidene-1,1-bisphosphonic acid; a non-reducing sugar diluent; a binder; a disintegrant; and a lubricant, and various other excipients.

Abstract: The present invention provides a method for preventing or treating osteoporosis in a castrated prostatic cancer patient, by administering to the patient an amount of from 10 mg to 300 mg cyproterone acetate per day. The present therapy is compatible with the patients' anti-cancer treatment.

Abstract: This invention relates to a method of preventing pregnancy and treating PMS including PMDD. More particularly, the invention relates to a method, which involves administering one of several combination oral contraceptive regimens in combination with an antidepressant and a kit containing the same.

Abstract: A novel pharmaceutical combination is described, together with a method of making the same and a method of treating hypertensive patients using the same, wherein (1) the pharmaceutically active antihypertensive agent and citric acid and (2) the pharmaceutically active antikaliuretic agent and a nonionic surfactant are mixed, either together or separately, to form an essentially homogenous combination composition, and only thereafter blending with excipients to form the novel combination composition in solid dosage form.

Abstract: A method for treating hot flashes in a castrated prostatic cancer patient who is diagnosed with hot flashes warranting treatment or who is experiencing at least approximately 5 hot flashes per day is provided in which from 25 mg to 150 mg cyproterone acetate per day is orally administered to the patient. A method for improving the multidimensional quality of life of such a patient is also provided. Palliative therapy for an advanced stage patient also improves quality of life.

Abstract: The invention provides a novel method of administering meperidine or its pharmaceutically acceptable salts and novel dosage forms containing these compounds which are adapted for nasal administration. The nasal dosage forms disclosed include solutions, suspensions, gels and ointments.