Baxter International Inc.

Baxter Healthcare Sa

Mark Joseph Doty

Christine L Rebbeck

James E Kipp

Joseph Chung Tak Wong

Sean Brynjelsen

William S Hurst

Barrett E Rabinow

Jane Werling

Wei-Youh Kuu

Jamie T Konkel

Ying-Cheng Lo

Thomas Edward Dudar

Yuanpang Samuel Ding

Joseph V Ranalletta

Bernd Krause

Karl Hans Cazzini

Mark Edward Pasmore

Grant Anthony Bomgaars

Michael Joseph Sadowski

Anastasios Hristakos

Sydney J Cope

Krishnaswamy Narayanan

Nailesh Jayswal

Marc Steven Minkus

Shmuel Sternberg

Chong-Son Sun

Pavlos Papadopoulos

Mahesh V Chaubal

Jason Mantei

David Filiberto Schuck

Robert W Garber, Ii

Sydney Jean Cope

Randy White

Jan Y Eilert

Rajaram Sriram

Neervalur V Raghavan

Joseph Chung Take Wong

Alfredo Rodriguez

Jamie Konkel

Joseph Vincent Ranalletta

Berthold Roessler

Provided is a system comprising a flexible container for intravenous administration which comprises a premix vasopressin pharmaceutical formulation, and uses thereof.

Vasopressin premix systems and uses thereof

An aqueous pharmaceutical composition suitable for parenteral administration and having enhanced storage stability includes between about 0.1 mg/mL and about 40 mg/mL micafungin; (ii) between about 0.1 mM and 400 mM buffering agent; and (iii) between about 0 mg/mL and about 500 mg/mL tonicity adjusting agent, wherein the pH of the composition is between about 3.0 and 7.0, for example, between about 3.5 and 7.0.

Micafungin compositions

A sterile solution product bag for lyophilizing includes a bladder, a first stem having a first stem inlet end and a first stem outlet end. The first stem outlet end is fluidly connected to the bladder and the first stem inlet end is adapted to receive a liquid. A first filter is disposed in-line with the first stem and includes a first filter membrane, a first filter open end, and a first filter closed end. The first filter closed end is disposed between the first stem inlet end and the first stem outlet end and the first filter open end is disposed in proximity to the first stem inlet end. A second stem having a second stem inlet end fluidly connected to the bladder and a second stem outlet end adapted to receive a vapor. A second filter is disposed within the second stem and includes a filter membrane.

Terminal sterilization filtration closed lyophilization in a container

A syringe system includes a syringe and a filtration device connected to the syringe for sterilizing and introducing fluid into the syringe. The syringe includes a syringe barrel having a proximal end defining a barrel opening, a distal end defining a delivery opening, a bore extending between the proximal end and the distal end, and a stopper disposed in the bore of the syringe barrel. The filtration device has an inlet and an outlet coupled in fluid communication with the delivery opening at the distal end of the syringe barrel. The filtration device includes a stem and a filter membrane disposed in line with the stem. The filter membrane optionally has a plurality of pores each with a nominal pore size in a range of approximately 0.1 &#x3bc;m to approximately 0.5 &#x3bc;m such that a pharmaceutical fluid can be introduced as a sterilized pharmaceutical fluid into the bore of the syringe barrel by passing through the filtration device.

Medical syringe system with filtered filling port

Submicron particles of an organic compound, such as therapeutic and diagnostic agent are disclosed. The organic compound particles are associated with at least two surfactants including a block copolymer and phospholipids conjugated with a hydrophilic polymer.

Surfactant systems for delivery of organic compounds

This application discloses devices, articles, and methods useful for producing lyophilized cakes of solutes. The devices and articles provide for a method of freezing liquid solutions of the solute by the top and the bottom of the solution simultaneously and at approximately the same rate. The as frozen solution can then provide a lyophilized cake of the solutes with large and uniform pores.

Optimization of nucleation and crystallization for lyophilization using gap freezing

The present invention relates to a process for preparing submicron sized nanoparticles of a poorly water soluble compound by lyophilizing a dispersion or microdispersion of a multiphase system having an organic phase and an aqueous phase, the organic phase having the poorly water soluble organic compound therein. The method is preferably used to prepare nanoparticles of a poorly water soluble, pharmaceutically active compound suitable for in vivo delivery, particularly by parenteral routes.

Preparation of submicron sized nanoparticles via dispersion lyophilization

The present invention provides a process for sterilizing a system, preferably a pharmaceutical preparation such as a dispersion of small particles or droplets of a pharmaceutically active compound using high pressure terminal sterilization techniques and products therefrom.

High-pressure sterilization to terminally sterilize pharmaceutical preparations and medical products

The present invention relates to compositions of submicron- to micron-size particles of antimicrobial agents. More particularly the invention relates to a composition of an antimicrobial agent that renders the agent potent against organisms normally considered to be resistant to the agent. The composition comprises an aqueous suspension of submicron- to micron-size particles containing the agent coated with at least one surfactant selected from the group consisting of: ionic surfactants, non-ionic surfactants, biologically derived surfactants, and amino acids and their derivatives. The particles have a volume-weighted mean particle size of less than 5 &#x3bc;m as measured by laser diffractometry.

Method for treating infectious organisms normally considered to be resistant to an antimicrobial drug

The present invention provides a polymorphic form of itraconazole.

Polymorphic form of itraconazole

The present invention discloses a composition of a stable suspension of a poorly water soluble pharmaceutical agent or cosmetic in the form of particles of the pharmaceutical agent or cosmetic suspended in a frozen aqueous matrix and method for its preparation. The composition is stable for a prolonged period of time, preferably six months or longer and is suitable for parenteral, oral, or non-oral routes such as pulmonary (inhalation), ophthalmic, or topical administration.

Compositions of and method for preparing stable particles in a frozen aqueous matrix

A premix parenteral solution for intravenous administration having amiodarone, as an active ingredient, solubilized in a solution of water for injection and about 0.4-12 mg/ml of a non-ionic surfactant to a concentration range of from 0.2 to 6 mg/ml is disclosed. The solution optionally may include an osmotic agent. No dilution of the solution is required before administering to a patient and the sterile packaged solution has an initial pH within the range of from about 2.9 to about 3.2, preferably about 3.1. Additionally, a method for producing an amiodarone solution suitable for intravenous administration is further disclosed.

Premixed amiodarone parenteral solution and method for making the same

The present invention provides a method for preparing submicron sized particles of an organic compound, the solubility of which is greater in a water-miscible first solvent than in a second solvent which is aqueous, the process including the steps of: (i) dissolving the organic compound in the water-miscible first solvent to form a solution, (ii) mixing the solution with the second solvent to define a pre-suspension; and (iii) adding energy to the pre-suspension to form particles having an average effective particle size of 400 nm to 2 microns.

Microprecipitation method for preparing submicron suspensions

Growing community of inventors

Grayslake, IL, United States of America

Mark Joseph Doty