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Pharmaceutical Manufacturing and Packing Sourcer
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Introduction
Recent advances in combinatorial chemistry techniques employed in the pharmaceutical industry have dramatically increased the number of new compounds for evaluation as drug candidates. Approximately half these new chemical entities contain hydrophobic substituents that result in the compounds exhibiting poor aqueous solubility. This lipophilic attribute offers the capability in tailoring the formulation of a new chemical entity into a lipid emulsion drug delivery system to accommodate the specific requirements of the disease with respect to stability, toxicity and efficacy in parenteral administration.
Types of Emulsions for Parenteral Drug Delivery
An emulsion is a dispersion of two or more immiscible liquids stabilised by a surfactant or emulsifier coating the droplets and preventing coalescence by reducing interfacial tension or creating a physical repulsion between the droplets (1). Two common types of emulsions are found in parenteral drug delivery systems. Water in oil emulsions (W/O) are used in sustained release of steroids and vaccines by intramuscular injection. Oil in water (O/W) or lipid emulsions can be administered by a variety of parenteral routes (for example subcutaneous, intramuscular, intra-arterial), but are predominantly injected intravenously in parenteral nutrition applications.
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By Jack Stevens, Associate Foundation Scientist, Pam Mims, Director of Product Support and Services and Neil Coles, Marketing and Business Development Liaison at Fresenius Kabi Clayton Inc
Jack Stevens is the Associate Formulation Scientist at Fresenius Kabi Clayton NC, a contract pharmaceutical manufacturing and development company of sterile parenteral products such as injectable solutions, liposomes or emulsions. Jack received a BS in Chemistry from Kutztown University and a MS in Chemistry from Villanova University and has been with the company for four years.
Pamela Mims is the Director of Product Support and Services and has been with Fresenius Kabi for over fifteen years. Her group consists of research scientists performing formulation development, process scale-up, analytical method development, validation and stability studies. Pam received her BS in Animal Science and her MS in Nutrition from North Carolina State University.
Neil Coles serves as the Marketing and Business Development Liaison at Fresenius Kabi and has been with the company for nine years. He is responsible for maintaining client relationships in contract research and manufacturing alliances, and is the US representative for business development for Fresenius Product Partnering. Neil is a graduate of the State University of New York at Buffalo School of Pharmacy, with a BS in Medicinal Chemistry.
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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
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News and Press Releases |
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Azopharma Product Development Group, Inc
HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today the addition of innovative state-of-the-art equipment at its formulation and manufacturing division, ApiCross Drug Delivery Technologies in Hollywood, Florida. The most recent acquisition is the MG Futura Capsule Filler which delivers the latest in capsule filling technology. The company has also added a Bausch & Strobel Aseptic Filling Isolator, equipment that is ground-breaking in the powder filling process. These additions support our previously implemented XcelodoseTM powder micro-dosing system. With these technologies, Azopharma is able to provide its clients with all forms of the capsule filling process. The new equipment is part of Azopharma’s recent manufacturing expansion which includes 17 new manufacturing suites for GMP, cytotoxic and aseptic products...
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