General Articles

General

Using Earned-Value Analysis for Better Project Management

EVA allows project managers to refer to tangible numbers, not just a gut feeling, in determining whether a project is advancing o­n time and within budget.

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Author(s): 
Heather B Hayes, a freelance writer, Jim Miller, publisher of the Bio/Pharmaceutical Outsourcing Report.
Journal: 
BioPharm International, March 2002.

Effect of Rise in Simulated Inspiratory Flow Rate and Carrier Particle Size on P

The purpose of this study was to evaluate the effect of carrier particle size and simulated inspiratory flow increase rate o­n emptying from dry powder inhalers (DPIs). Several flow rate ramps were created using a computer-generated voltage signal linked to an electronic proportioning valve with a fast response time. Different linear ramps were programmed to reach 30, 60, 90, and 120 L/minute over 1, 2, or 3 seconds. At the lower flow rates, 100-ms and 500-ms ramps were also investigated. Three DPIs, Spinhaler, Rotahaler, and Turbuhaler, were used to test the effect of flow rate ramp o­n powder emptying. To test the effect of carrier particle size, anhydrous lactose was sieved into 3 particle sizes, and 20 mg of each was introduced into #2 and #3 hard gelatin capsules for Spinhaler and Rotahaler, respectively. Emptying tests were also carried out using the o­n/off solenoid valve described in the United States Pharmacopeia (USP) (resulting in no ramp generation).

Author(s): 
Varsha Chavan, Richard Dalby.
Journal: 
AAPS PharmSci. 2000; 2 (2): article 10

Getting the Most from Contract Service Providers

Richard S Wood ward
November and December 2000

Spherical Composite Particles of Rice Starch and Microcrystalline Cellulose:

Composite particles of rice starch (RS) and microcrystalline cellulose were fabricated by spray-drying technique to be used as a directly compressible excipient. Two size fractions of microcrystalline cellulose, sieved (MCS) and jet milled (MCJ), having volumetric mean diameter (D50) of 13.61 and 40.51 µm, respectively, were used to form composite particles with RS in various mixing ratios. The composite particles produced were evaluated for their powder and compression properties. Although an increase in the microcrystalline cellulose proportion imparted greater compressibility of the composite particles, the shape of the particles was typically less spherical with rougher surface resulting in a decrease in the degree of flowability.

Author(s): 
Vasinee Limwong, Narueporn Sutanthavibul, Poj Kulvanich.
Journal: 
AAPS PharmSciTech. 2004; 5(2): article 30.

Cipro Soars in Cyberspace

Washington, DC-The run o­n Cipro following October's anthrax scare was a bonanza for pharmacy websites, but it stirred the wrath of both FDA and the medical establishment. In response to escalating ciprofloxacin promotion over the internet, FDA sent cyber letters to 11 websites for offering US consumers products that may not be approved for sale in the United States, warning that US Customs might detain shipments. The agency also took more stringent action against five previously warned foreign vendors. For full article Click Here

Author(s): 
Jill Wechsler.
Journal: 
Pharmaceutical Executive, Dec 1, 2001 .

Negotiating and Structuring Strategic Alliances

David Schulman, Dechert London; and Joe Zammit-Lucia, Chris Easley, Cambridge Pharma Consultancy
BioPharm International, June 2002

Dynamic Changes in Size Distribution of Emulsion Droplets During Ethyl Acetate

Abstract

This study investigated the dynamic effect of the emulsification process o­n emulsion droplet size in manufacturing microspheres using ethyl acetate as an organic solvent. A dispersed phase consisting of poly(lactide-co-glycolide) and ethyl acetate was emulsified in a poly(vinyl alcohol) aqueous solution for a predetermined time ranging from 2 to 9, 16, 23, 30, 40, 50, or 60 minutes. Ethyl acetate was then quickly extracted to transform emulsion droplets into solidified microspheres, and their size distribution was determined. This experimental design allowed quantification of the size distribution of emulsion droplets over the course of emulsification. When emulsification time was extended from 2 to 60 minutes, the emulsion droplets decreased in size from 98.1 to 50.3 μm and their surface area increased from 0.07 to 0.29 m2/g.

Author(s): 
Yogita Bahl, Hongkee Sah.
Journal: 
AAPS PharmSciTech. 2000; 1(1): article 5.

A Sweet Piece of the Food Pyramid

NIST has “raised the bar” with standard values for key nutrients in baking chocolate. Everybody loves chocolate!” Although this may not be entirely true, chocolate does have an amazing ability to draw people to the candy bowl, dessert tray, or snack counter. According to a study conducted by researchers at the University of Texas and the Hershey Corporation, people started enjoying the smooth, sweet, semisweet, or bittersweet taste of this cocoa bean extract in foods and beverages as early as 600 B.C.

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Author(s): 
Pili A. Hawes.
Journal: 
Today's Chemist At Work, Nov 2004.

Formulation of Hydrophobic Drugs Into Cochleate Delivery Vehicles

Cochleate delivery vehicles represent a new technology platform for oral and systemic delivery of drugs. A novel lipid-based system, they represent a unique technology platform suitable for the oral and systemic administration of a wide variety of molecules with important therapeutic biological activities, including drugs, genes, and vaccine antigens. Cochleate formulation technology is particularly applicable to macromolecules as well as small molecule drugs that are hydrophobic, positively charged, negatively charged, and that possess poor oral bioavailability. Proof-of-principle studies for cochleate-mediated oral delivery of macromolecules as well as small molecule drugs is being carried out in appropriate animal models with well established, clinically important drugs, which currently can o­nly be effectively delivered by injection.

Author(s): 
David Delmarre, Ruying Lu; Nadine Tatton, Sara Krause-Elsmore, Susan Gould-Fogerite, and Raphael J. Mannino.
Journal: 
Drug Delivery Technology, Vol 4 No 1 · January/February 2004 .

Infinity from Zero

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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Author(s): 
Wayne Koberstein.
Journal: 
Pharmaceutical Executive, Feb 1, 2002.
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