Abstract: Compositions containing and methods of administering TH-4000 are useful in treatment of cancer alone or in combination with other anti-cancer agents.

Abstract: The present invention provides a new method for making TH-302 and solid forms thereof. The compound in its solid form is an effective anti-cancer agent and may be used in various pharmaceutical compositions, and are particularly effective for the treatment of cancer. The invention also provides a method for preparing such compounds and forms and for treating cancer in a mammal comprising the step of administering a therapeutically effective amount of a solid form of TH-302 thereof.

Abstract: The invention provides a method of preparing a lyophilized pharmaceutical composition containing a compound described herein or a pharmaceutically-acceptable salt thereof. The process comprises dissolving the compound in a solvent comprising dimethylsulfoxide and optionally one or more co-solvents to form a solution, and then removing the solvent and any co-solvents by a freeze-drying process. Also provided by the invention are lyophilized pharmaceutical compositions and their use in medicine and in particular in the treatment of cancer.

Abstract: The present invention provides a new method for making TH-302 and solid forms thereof. The compound in its solid form is an effective anti-cancer agent and may be used in various pharmaceutical compositions, and are particularly effective for the treatment of cancer. The invention also provides a method for preparing such compounds and forms and for treating cancer in a mammal comprising the step of administering a therapeutically effective amount of a solid form of TH-302 thereof.

Abstract: Compositions containing and methods of administering TH-4000 are useful in treatment of cancer alone or in combination with other anti-cancer agents.

Abstract: The present invention provides a new method for making TH-302 and solid forms thereof. The compound in its solid form is an effective anti-cancer agent and may be used in various pharmaceutical compositions, and are particularly effective for the treatment of cancer. The invention also provides a method for preparing such compounds and forms and for treating cancer in a mammal comprising the step of administering a therapeutically effective amount of a solid form of TH-302 thereof.

Abstract: Dosage forms and methods for providing a substantially ascending rate of release of paliperidone or risperidone are provided. The sustained release dosage forms provide therapeutically effective average steady-state plasma paliperidone or risperidone concentrations when administered once per day. This once-a-day dosing regimen results in only one peak plasma paliperidone or risperidone concentration occurrence in each 24 hour period. In addition, the peak plasma paliperidone or risperidone concentration occurs at a later time following dose administration and exhibits a lesser magnitude than the peak plasma paliperidone or risperidone concentration that occurs following administration of paliperidone or risperidone in an immediate-release dosage form.

Abstract: Non-effervescent pharmaceutical compositions having at least one particle of carbonate coated by a layer of polyethylene glycol that substantially covers the at least one carbonate particle are described. Compositions are also described where the compositions include a weakly basic therapeutic agent, a first pH-modifying agent having at least one particle of carbonate coated by a layer of polyethylene glycol, and a second pH-modifying agent. The weakly basic therapeutic agent could be, but is not limited to, zolpidem or scopolamine. Compositions including zolpidem and scopolamine are used to treat insomnia and depression, respectively.

Abstract: Disclosed are dosage forms and methods comprising benzisoxazole derivatives. More particularly, disclosed are dosage forms, methods, and new uses of benzisoxazole derivatives that substantially reduce or substantially eliminate certain side effects of the benzisoxazole derivatives when dosed to a patient.

Abstract: Compositions for once-daily administration of ondansetron are described. Compositions include a core, a semi-permeable membrane disposed generally around the core, an orifice in the semi-permeable membrane in fluid communication with the core, and a coating having a first therapeutically effective dose of ondansetron or a pharmaceutically acceptable salt disposed generally around the semi-permeable membrane. The core includes first, second, and third layers. The first layer is in fluid communication with the orifice. The second layer includes a second therapeutically effective dose of ondansetron or a pharmaceutically acceptable salt and is located adjacent to the first layer. The third layer is located adjacent the second layer. Methods for treating obsessive compulsive disorder by administering these compositions are also described.

Abstract: A trilayer osmotic tablet is described. The tablet includes a core, a semi-permeable membrane disposed generally around the core, and an orifice in the semi-permeable membrane in fluid communication with the core. The core includes first, second, and third layers. The first layer is in fluid communication with the orifice. The second layer includes a therapeutically effective dose of a drug and is located adjacent to the first layer. The third layer is located adjacent the second layer. The tablet may include a coating having therapeutically effective doses of at least one additional drug disposed in the coating that generally surrounds the semi-permeable membrane. The at least one additional drug in the coating may be the same or different from the drug in the trilayer core. Methods for treating epilepsy, psychiatric disorders, asthma, and peptic ulcer disease by administering these compositions are also described.

Abstract: Disclosed are dosage forms and methods comprising benzisoxazole derivatives. More particularly, disclosed are dosage forms, methods, and new uses of benzisoxazole derivatives that substantially reduce or substantially eliminate certain side effects of the benzisoxazole derivatives when dosed to a patient.

Abstract: Non-effervescent pharmaceutical compositions having at least one particle of carbonate coated by a layer of polyethylene glycol that substantially covers the at least one carbonate particle are described. Compositions are also described where the compositions include a weakly basic therapeutic agent, a first pH-modifying agent having at least one particle of carbonate coated by a layer of polyethylene glycol, and a second pH-modifying agent. The weakly basic therapeutic agent could be, but is not limited to, zolpidem or scopolamine. Compositions including zolpidem and scopolamine are used to treat insomnia and depression, respectively.

Abstract: Non-effervescent pharmaceutical compositions having at least one particle of carbonate coated by a layer of polyethylene glycol that substantially covers the at least one carbonate particle are described. Compositions are also described where the compositions include a weakly basic therapeutic agent, a first pH-modifying agent having at least one particle of carbonate coated by a layer of polyethylene glycol, and a second pH-modifying agent. The weakly basic therapeutic agent could, but is not limited to, be zolpidem or scopolamine. Compositions including zolpidem and scopolamine are used to treat insomnia and depression, respectively.

Abstract: Disclosed are methods of sustained release administration of opioids, including but not limited to hydromorphone and oxycodone, that exhibit improved properties with respect to co-ingestion with aqueous alcohol.

Abstract: Dosage forms and methods for providing a substantially ascending rate of release of paliperidone or risperidone are provided. The sustained release dosage forms provide therapeutically effective average steady-state plasma paliperidone or risperidone concentrations when administered once per day. This once-a-day dosing regimen results in only one peak plasma paliperidone or risperidone concentration occurrence in each 24 hour period. In addition, the peak plasma paliperidone or risperidone concentration occurs at a later time following dose administration and exhibits a lesser magnitude than the peak plasma paliperidone or risperidone concentration that occurs following administration of paliperidone or risperidone in an immediate-release dosage form.

Abstract: Improvements in a mini-osmotic pump and coating compositions are described. The dispensing pump includes an inner fluid-filled bag encased by an osmotic layer and outer, semi-permeable membrane. The inner bag is formed with an arcuate edge at the open end of the bag to inhibit formation of fissures in the outer membrane in this edge region. The coating compositions include cellulose acetate butyrate, cellulose acetate propionate, and polymethylmethacrylate polymers, optionally mixed with ethyl cellulose in acetone based solvent systems.

Abstract: Improvements in a mini-osmotic pump and coating compositions are described. The dispensing pump includes an inner fluid-filled bag encased by an osmotic layer and outer, semi-permeable membrane. The inner bag is formed with an arcuate edge at the open end of the bag to inhibit formation of fissures in the outer membrane in this edge region. The coating compositions include cellulose acetate butyrate, cellulose acetate propionate, and polymethylmethacrylate polymers, optionally mixed with ethyl cellulose in acetone based solvent systems.

Abstract: Disclosed are osmotic dosage forms including a semi-permeable membrane; a first and a second orifice in the semi-permeable membrane located at opposite ends of the semi-permeable membrane; a controlled release drug layer located adjacent to the first orifice and within the semi-permeable membrane; a fast release drug layer located adjacent to the second orifice and within the semi-permeable membrane; a push layer located within the semi-permeable membrane and between the controlled release drug layer and the fast release drug layer; a barrier layer slidably located between the push layer and the fast release drug layer; and wherein an area of the second orifice is greater than or equal to about 7800 mil2. Also disclosed are methods of making and using such osmotic dosage forms.

Abstract: Disclosed are osmotic dosage forms and methods that provide for fast release of drugs together with controlled release of drugs. In an aspect, disclosed are osmotic dosage forms including: a semi-permeable membrane; a lubricating subcoat located within the semi-permeable membrane; an orifice in the semi-permeable membrane located at an end of the semi-permeable membrane; a drug layer located adjacent to the orifice and within the lubricating subcoat; a push layer located within the lubricating subcoat and on a side of the drug layer opposite from the orifice; wherein an area of the orifice is greater than or equal to about 1,600 mil2; and wherein the drug layer comprises from about 20 wt % to about 90 wt % microcrystalline cellulose, and less than or equal to about 10 wt % of a drug, based on the total weight of the drug layer. Also disclosed are methods of making osmotic dosage forms.