Pharmaceutical Technology, Oct 2, 2007 - Pharmaceutical Technology

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Pharmaceutical Technology, Oct 2, 2007
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Sustainable Packaging Resources
By Hallie Forcinio
When it comes to designing and sourcing sustainable packaging, there are no simple answers. Sustainable packaging depends on a complex interaction of environmental, social, and economic considerations, which are influenced by geography and other factors such as renewability, compostability, biodegradability, weight, and performance.
Special Report
Advances in Transdermal Technologies
By Maribel Rios
Transdermal delivery takes up once-forbidden compounds, reviving markets and creating formulation opportunities.
Peer-Reviewed Research
Strategy for the Prediction and Selection of Drug Substance Salt Forms
By Harry G. Brittain, PhD
Through consideration of the ionic equilibria of acids and bases, one may readily calculate the formation constant of a salt species solely on the basis of knowledge of the pKA value of the acid and the pKB value of the base.
Materials of Construction Based on Recovery Data for Cleaning Validation
By Richard J. Forsyth , Julia C. O'Neill , Jeffrey L. Hartman
The material of construction is a factor in the recovery of residue in cleaning validation. An analysis of existing recovery data showed that recovery factors for drug products on various materials of construction may be categorized into several groupings.
Functionality-Related Characteristics of Excipients
By Henning G. Kristensen
Amidst debate, the European Pharmacopoeia Commission is working to include physical or "functionality-related characteristics" of exipient materials in its monographs.
Acceptance Limits for the New ICH USP 29 Content-Uniformity Test
By James S. Bergum , Hua Li, PhD
Revisions to the United States Pharmacopeia's (USP) uniformity test require manufacturers to establish new acceptance limits. The authors present their method for calculating acceptance limits consistent with USP's revised content-uniformity test requirements.
Converting Intravenous Dosing to Subcutaneous Dosing With Recombinant Human Hyaluronidase
By Michael F. Haller
The preferred route of administration for an injected therapeutic agent is subcutaneous (SC), but SC injections are generally limited to no more than 1-2 mL in volume, representing a major challenge, especially for large protein biologics.
The Application of Quality by Design to Analytical Methods
By Phil Borman , Phil Nethercote , Marion Chatfield , Duncan Thompson , Keith Truman
To monitor and control processes or products, analytical methodology must be fit for purpose. An approach to apply quality by design principles to the design and evaluation of analytical methods has therefore been developed to meet these needs.

This article features a downloadable template on which to conduct a failure mode effect analysis (FMEA).
Articles
Advancing ODT Technology
By Patricia Van Arnum
Orally disintegrating tablets (ODTs) continue to attract attention as an alternative to conventional oral dosage forms.
Packaging Forum
Packagers Pursue Sustainability
By Hallie Forcinio
Nonpharmaceutical manufacturers find ways to make environmentally sound packaging.
Washington Report
Medicare Drug Benefit Boosts Pharmaceutical Use
By Jill Wechsler
Expanded access to drugs for seniors has increased demand and focused attention on costs.
Outsourcing
Avoiding Subprime Contractors and Contracts
By Jim Miller
Could sloppy due diligence practices hurt CMOs and their clients?
Agent-In-Place
Agent in Place: Vials and Villains
By Control, a senior compliance officer
Our files pull up lost contracts, poor competitive tactics, and an over-ambitious employee.
Viewpoint
Manufacturing One Trend at a Time
By R. Christian Moreton
Change is inevitable, as is contract manufacturing. But which companies will survive the drifts?
From The Editor
Who's in Charge?
By Michelle Hoffman
Courts are denying the terminally ill access to experimental drugs, leaving many with no options.
This Time Around
We Need More Overseas Inspections
By Angie Drakulich
Offshore contracting is nothing new for the pharmaceutical industry. Neither is importing active ingredients, or prescription drugs, for that matter. But the authorities are having trouble keeping up with these growing international trends.
Book Review
Charting a Path to Purity
By Sanjay Garg, PhD
Regulators and industry professionals provide a guide for identifying and measuring impurities.
In the Field
In the Field
The United States House of Representatives passed its version of the Patent Reform Act of 2007 (H.R. 1908) in September in a 220-175 vote. Although the bill aims to fix current flaws in the US patent system and to bring it in line with those of other countries' systems, the biopharmaceutical industry is largely unhappy with the news, arguing that it will reduce patent protection.
In the Spotlight
In the Spotlight
Carl Zeiss MicroImaging (Thornwood, NY) recently introduced its "Colibri" light-emitting diode (LED) light source for fluorescence microscopy. The product is "the only LED light source optimized for white-field microscopy systems," says Becky Homan, product manager for biomedical light microscopy.
Pharma Capsules
Pharma Capsules
Lancaster Laboratories (Lancaster, PA) acquired Microchem Laboratories (Waterford, Ireland). Microchem was established in 1986 and is one of Ireland's testing and research laboratories. Microchem offers microbiological, chemical, and environmental analyses to the pharmaceutical, medical-device, and chemical industries in Europe and Asia.

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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