Otsuka Pharmaceutical Company, Limited

Alza Corporation

Molecular Templates, Inc.

Taiho Pharmaceutical Company Limited

Durect Corporation

Nipun Davar

Atul D Ayer

Mark D Matteucci

Jian-Xin Duan

Rajashree Joshi-Hangal

Masahiro Miyake

Denise Andersen

Aram Oganesian

Gemma Zuend

Ian Scott

Stephen R Priebe

Suneel K Gupta

Patrick S L Wong

Brenda J Pollock

Evangeline Cruz

Motoshi Matsui

Kimiyoshi Annaka

Jim Hwaicher Kou

Padmaja Shivanand

Paul Minn Hwang

Gayatri Sathyan

Julie Lee

Sonya Seroff

Nyomi V Yam

Iran Reyes

Hem Raj Khatri

Noymi V Yam

Prabhudas Bodhuri

Jayne Hastedt

Gemma Casadevall

Gaytri Sathyan

Linda Pors

Embodiments of the present invention provide solid oral dosage forms that upon daily administration to a subject provide plasma levels of decitabine with a 5-day AUC for decitabine that is equivalent to the 5-day AUC for a daily IV dose of decitabine of 20 mg/madministered as a one hour (1 h) infusion. Also provided according to embodiments of the present invention are solid oral dosage forms wherein upon daily administration to a subject provides a pharmacodynamic effect that is equivalent to the pharmacodynamic effect for a daily intravenous dose of decitabine of 20 mg/madministered as a one hour (1 h) infusion. Also provided are methods of treatment using a solid oral dosage form according to an embodiment of the invention.

Combination decitabine and cedazuridine solid oral dosage forms

The invention relates to methods of synthesizing 2'-deoxy-2′,2′-difluorotetrahydrouridine with increased purity and uniform particle size distribution. In particular, methods of the invention include crystallization and isolation procedures rendering synthetic reaction intermediates. The invention further includes compositions comprising the final compound in highly pure form, including lower number of impurities and lower levels of individual and total impurities.

2'-deoxy-2′,2′-difluorotetrahydrouridines with high purity and methods of making the same

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.

Drug compound and purification methods thereof

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.

TH-302 solid forms and methods related thereto

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.

Methods and dosage forms for controlled delivery of paliperidone and risperidone

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.

Osmotically-driven fluid dispenser

A dosage form is disclosed for administering a leukatriene-receptor antagonist to a patient over time.

Anti-asthma therapy

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Pleasanton, CA, United States of America

Nipun Davar