General Articles

The objective of this study was to investigate the influence of processing parameters o­n the morphology, porosity, and crystallinity of polymeric polyethylene glycol (PEG) microparticles by spray freezing into liquid (SFL), a new particle engineering technology. Processing parameters investigated were the viscosity and flow rate of the polymer solution, nozzle diameter, spray time, pressure, temperature, and flow rate of the cryogenic liquid. By varying the processing parameters and feed composition, atomization and heat transfer mechanisms were modified resulting in particles of different size distribution, shape, morphology, density, porosity, and crystallinity. Median particle diameter (M50) varied from 25 µm to 600 µm. Particle shape was spherical or elongated with highly irregular surfaces. Granule density was between 0.5 and 1.5 g/mL. In addition to producing particles of pure polymer, drug particles were encapsulated in polymeric microparticles.

In the ever-changing pharmaceutical industry, an organization’s ability to act with speed is often the difference between success and failure. Never before have large multinational healthcare companies been under so much pressure to increase earnings year to year and often quarter to quarter. o­ne way in which these companies can increase earnings and revenue is to bring new products to market faster. For a projected $150 million product, a o­ne-month delay in commercializing or launching can result in a sales loss of more than $12 million.
A key strategy for accelerating new products in the healthcare industry is outsourcing. Outsourcing, or the use of contract services, allows sponsor organizations to access technology, capacity, resources and expertise that may not be readily available in-house.

Gil Y. Roth
Contract Pharma June 2001

Perchlorate salts are being used as rocket propellants in fireworks and in the electroplating industry. Currently, there is a major concern for bio-accumulation of perchlorate in major vegetable and fruit crops. The farming industry is monitoring perchlorate in crops of lettuce, spinach, green o­nions, lemon (citrus fruits), alfalfa and strawberries among others. It is evident that any vegetable which has high water content will accumulate more perchlorate.


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Who, or what, creates wealth? Answering that question has become as much political football as economic theory. Last month, the US president reminded us that government does not make wealth but, at best, fosters a climate conducive to it. The old-left idea that workers create and should share equally in the fruits of production has long since died of exhaustion. By process of elimination, the o­nly apparent answer remaining belongs to idealistic capitalists, who herald the enterprising companies from which all wealth "obviously" flows-for most of us, as paychecks.

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The objective of this study was to prepare and characterize microparticles of budesonide alone and budesonide and polylactic acid (PLA) using supercritical fluid (SCF) technology. A precipitation with a compressed antisolvent (PCA) technique employing supercritical CO2 and a nozzle with 100-µm internal diameter was used to prepare microparticles of budesonide and budesonide-PLA. The effect of various operating variables (temperature and pressure of CO2 and flow rates of drug-polymer solution and/or CO2) and formulation variables (0.25%, 0.5%, and 1% budesonide in methylene chloride) o­n the morphology and size distribution of the microparticles was determined using scanning electron microscopy. In addition, budesonide-PLA particles were characterized for their surface charge and drug-polymer interactions using a zeta meter and differential scanning calorimetry (DSC), respectively.

Patents before profits. That soundbite snagged my ears and turned my full attention to the CNN business report. I recognized the voice and the face-Ray Gilmartin, chairman of Merck. Calmly and reasonably, he explained how extraordinary circumstances in the developing world demand that his company uncouple the normally fused objectives of high profitability and unwavering patent protection.

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As the costs of pharmaceutical development continue to increase and the new opportunities for facilitated drug and biologics development lead to more complex decision-making, the choice of an outsource provider to aid in the regulatory process becomes even more critical. Those of us who believe that regulatory affairs is the center of the product development universe are more convinced than ever that this process can be immeasurably aided by the appropriate and targeted use of experienced consultants.

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Bryan D. Tweedy
Modern Drug Discovery, Aug 2004

Both sides of the political spread now contain active elements that invoke anti-industry sentiments for their populist propaganda. o­n the right, Arianna Huffington and Jerry Falwell take regular shots at pharma. With all the alacrity of their leftist cousins, the rightist demagogues throw out attack adjectives like "price-gouging" and "profit-hungry" to describe the industry.

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