University of Kansas

Cydex Pharmaceuticals, Inc.

Silvergate Pharmaceuticals Inc.

Crititech, Inc.

U.S. Bioscience, Inc.

Cydex, Inc.

Silvergate Pharmacauticals, Inc.

Roger A Rajewski

Bala Subramaniam

Valentino J Stella

John L Haslam

Lian G Rajewski

Michael C Beckloff

Peter Colabuono

Robert Mauro

Kathleen Heppert

James D Pipkin

Beau Mainous

Frank Segrave

James William McGinity

Said Saim

Paul Edwin Kennedy

Fenghui Niu

John M Baldoni

Gerold L Mosher

Ingrid Gunda Georg

Michelle McIntosh

Mehmet Tanol

Venkatramana M Rao

Katherine F Terranova

William K Snavely

Jeffrey M Jonas

Frank Seagrave

David J Bochniak

Katherine Fern Terranova

Said Said

Cosmetic and dietary supplement compositions containing silymarin and sulfoalkyl ether cyclodextrin, particularly sulfobutyl ether cyclodextrin, are described. The compositions and methods are useful in reducing appearance of facial redness in rosacea-prone skin, rejuvenating skin, preventing skin aging, inhibiting oxidative stress in epidermal and dermal cells, increasing collagen production, reducing the likelihood of skin cancer, treating or reducing liver damage from a toxin, or treating a liver disease.

Compositions containing silymarin and sulfoalkyl ether cyclodextrin and methods of using the same

Provided herein are stable enalapril powder compositions for oral liquid formulation. Also provided herein are methods of using enalapril oral liquid formulations for the treatment of certain diseases including hypertension, heart failure and asymptomatic left ventricular dysfunction.

Enalapril compositions

The present disclosure provides rapidly dissolving oral capsules and films comprising pullulan, a plasticizer, and a dissolution enhancing agent.

Rapidly dissolving pharmaceutical compositions comprising pullulan

A prodrug that has a prodrug moiety that degrades into a compound having the general Formula I with R3 being an alcoholic moiety can be useful in therapies for neurodegenerative diseases as well as cancer. Accordingly, the prodrug compounds can have a structure of Formula I, analogs thereof, derivatives thereof, or salts thereof, wherein: A and B are sulfur or oxygen; R1 and R2, in para, meta, or ortho position, are independently halogen, alkyl, alkoxy, haloalkyl, where R1 and R2 independently are straight chain, branched, substituted or unsubstituted; and R3 is a prodrug moiety. As examples, the prodrug can have a structure of any of Formulas I-V, which as shown in the specification.

Prodrugs of (3,5-bis(4-fluorophenyl)tetrahydro-1H-oxazolo[3,4-C]oxazol-7A-yl)methanol and derivatives thereof

The present embodiment of the invention is generally directed to compositions comprising suspensions of poorly water-soluble compounds recrystallized in nanoparticulate sizes ranging from 0.1 to 5 &#x3bc;m. In addition, the embodiment of the invention is directed to methods for preparation and administration of these compositions to a patient for prevention and treatment of disease states. In particular, the embodiment of the invention is directed to compositions comprising suspensions of poorly water-soluble compounds, such as antimitotics and antibiotics, in nanoparticulates and methods of prevention and treatment of chronic disease states, such as cancer, by intraperitoneal and intravenous administration of such compositions.

Compositions and methods for the delivery of poorly water soluble drugs and methods of treatment

The present invention provides an orally dissolving capsule comprising pullulan, a plasticizer and a dissolution enhancing agent.

Commercially feasible methods for lyophobic precipitation of liquid-dispersed or dissolved material (e.g., medicaments) are provided wherein a plurality of individual, open containers () each containing a quantity () of a solution or dispersion are treated within a common pressurizable chamber (). In this process, desired near-supercritical or supercritical temperature and pressure conditions are established for a selected antisolvent gas such as carbon dioxide, and an ultrasonic device () is actuated to generate high energy ultrasonic waves in the chamber (). This leads to intense mixing of the antisolvent with the liquid solution or dispersion within the containers (), with consequent solvent removal and material precipitation.

Method for precipitation of small medicament particles into use containers

A process for forming small micron-sized (1-10 &mgr;m) protein particles is provided wherein a protein, a solvent system for the protein and an antisolvent for the protein solvent system are contacted under conditions to at least partially dissolve the protein solvent system in the antisolvent, thereby causing precipitation of the protein. The solvent system is made up of at least in part of a halogenated organic alcohol, most preferably 1,1,1,3,3,3-hexafluoro-2-propanol (HFIP). Preferably, a solution of the protein in the solvent system is sprayed through a nozzle into a precipitation zone containing the antisolvent (preferably CO ) under near- or supercritical conditions.

Precipitation of proteins from organic solutions

Processes and apparatuses are provided for continuously harvesting particles from organic solution-laden near-critical and supercritical fluids. Broadly, the processes and apparatuses utilize a filter or separator comprising a thin membrane supported on a sintered stainless steel tube. A feed stream comprising the desired particles, a supercritical antisolvent for the particles (preferably CO.sub.2), and a solvent for the particles, is contacted with the membrane layer of the filter under supercritical conditions for the mixture of antisolvent and solvent. The preferred antisolvents are substantially miscible with the solvent and have a critical temperature of less than 160.degree. C. The desired particles are retained by the filter while the solvent and most of the antisolvent pass through the filter, resulting in separation of the particles from the solvent.

Process and apparatus for size selective separation of micro- and

Sulfoalkyl ether cyclodextrin (SAE-CD) based controlled release pharmaceutical formulations are provided by the present invention. The present solid pharmaceutical formulations consist of a core comprising a physical mixture of one or more SAE-CD derivatives, an optional release rate modifier, a therapeutic agent, a major portion of which is not complexed to the SAE-CD, and an optional release rate modifying coating surrounding the core. The present formulations are advantageously easier to prepare than other SAE-CD based formulations in the art yet provide similar or improved effectiveness. The SAE-CD derivative is used to modify the bioavailability and/or rate of bioabsorption of therapeutic agents. Multi-layered, osmotic pump, coated, and uncoated tablet, minitablet, pellet, micropellet, particle, powder, and granule dosage forms are disclosed herein.

Sulfoalkyl ether cyclodextrin based controlled release solid

Growing community of inventors

Lawrence, KS, United States of America

Roger A Rajewski