Abstract: The present invention is directed to novel drug compositions and dosage forms comprising said drug compositions. The drug compositions of the present invention comprise a pharmaceutical agent and a solubilizing agent. The drug compositions of the present invention are particularly advantageous for use with low solubility and/or low dissolution rate pharmaceutical agents. The present invention is further directed to methods for manufacturing of said drug compositions and dosage forms. The present invention is further directed to methods of treatment comprising administration of said drug compositions and dosage forms.

Abstract: A dosage form that facilitates the controlled release of an active agent at a desired release rate or release rate profile includes a bi-layer membrane system and an osmotic core. The bi-layer membrane system includes a semipermeable membrane and an osmosensitive membrane and forms an internal compartment occupied by the osmotic core. The osmotic core includes an active agent composition and a light push layer. A passageway is formed through the bi-layer membrane system and permits expulsion of the active agent composition from the dosage form during operation. The bi-layer membrane system and the osmotic core are formulated and formed to provide controlled release of the active agent included in the active agent composition, while simultaneously facilitating increased loading of active agent within a dosage form of given dimension and increasing the delivery efficiency of such active agent relative to prior osmotic dosage forms including a push layer.

Abstract: A membrane system comprising an interior wall, a fluid-permeable exterior wall surrounding the interior wall and an internal compartment defined by the membrane system, wherein fluid permeability of the interior wall is responsive to osmolarity of an osmotic core within the internal compartment are disclosed. A controlled release dosage form comprising the membrane system and a process for delivering an osmotically active formulation from an osmotic pump over an extended period of time are also disclosed.

Abstract: Disclosed are oral osmotic dosage forms and methods wherein a semi-permeable membrane of the oral osmotic dosage form includes from about 23 wt % to about 50 wt % of a flux enhancer and from about 0.01 wt % to about 5 wt % of antioxidant, based on the total dry weight of the semi-permeable membrane. Such compositions provide high flux membranes with improved mechanical and transport stability during storage on the shelf.

Abstract: Dosage forms and devices for enhancing controlled delivery of pharmaceutical agents by use of a drug core composition that increases the solubility of the pharmaceutical agent are described. The present invention provides a means of delivering high doses of poorly soluble drug in oral drug delivery systems that are convenient to swallow, for once-a-day administration.

Abstract: A sustained release dosage form is disclosed, which dosage form comprises an interior lipophilic membrane, and an exterior hydrophilic membrane comprising a peptide, that surround a composition comprising a drug. The dosage form at the end of its drug delivery period self-ruptures for enhancing its exit from the environment of use.

Abstract: Dosage forms and devices for enhancing controlled delivery of lowly soluble active agents including topiramate by use of a drug core composition that increases the solubility of the pharmaceutical agent are described. The present invention provides a drug core composition for delivering high doses of lowly soluble topiramate in solid oral drug delivery systems that are convenient to swallow, for once-a-day administration. The drug core composition contains topiramate, a surfactant and a carrier in ratios for optimal solubility and delivery.

Abstract: Dosage forms and devices for enhancing controlled delivery of pharmaceutical agents by use of a drug core composition that increases the solubility of the pharmaceutical agent are described. The present invention provides a means of delivering high doses of lowly soluble drug in oral drug delivery systems that are convenient to swallow, for once-a-day administration.