Pharmaceutical Technology, Apr 2, 2007 - Pharmaceutical Technology

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Pharmaceutical Technology, Apr 2, 2007
Articles
Pharmaceutical Technology's Equipment and Machinery Spending Survey
The pharmaceutical industry plans moderate increases in spending for equipment and machinery in 2007 as expenditures hold steady.
Continuous Processing—Finally
By Maribel Rios
Alternatives to batch processing finally are starting to be taken seriously by pharmaceutical manufacturers, but the implemention of continuous processing is still in its infancy, and many challenges remain.
India: the Gateway to Pharma
By Yaz Yazicioglu , Emmanuelle Berthemet
Forty years ago, investors and business speculators shuddered at the prospect of working with India's pharmaceutical industry. The industry was plagued by archaic patent laws and insufficient infrastructure, and only multinational companies (MNCs) were able to exploit its crude resources and monopolistic legal framework. Struggling in the shadows of these MNCs were the Indian pharmaceutical entrepreneurs and a handful of producers. Because more than 70% of the pharmaceutical market value was in the hands of MNCs, India's indigenous pharmaceutical industry was floundering. Its amount of exports was negligible, and the domestic market outlook was bleak because of onerous government regulation.
Expanding Opportunities for Specialty Excipients
By Patricia Van Arnum
China creates a potential outlet for specialty excipients as its pharmaceutical market grows.
India's Pharmaceutical Machine Manufacturers: From Imitation to Innovation
By Yaz Yazicioglu , Emmanuelle Berthemet
Indian pharmaceutical machine manufacturers (IPMMs) are exceptional among their foreign counterparts. Historically similar to the Chinese with regard to copycat practices, patent infringements, and substandard quality, the IPMMs have made great strides in innovation and collaboration to break free from the shackles of this paradigm.
Indian Pharma Sector: Evolving to Innovation
By Dr. A.D. lakdawala
The enactment of the Indian Patents Act of 1970, implemented in 1972, provided an open platform to the Indian pharmaceutical industry to adopt process patents to manufacture active pharmaceutical ingredients (APIs) and formulations without fear of infringement of product patents. This resulted in a phenomenal growth in the number of pharmaceutical manufacturing units, from 2257 in 1970, to 5156 in 1980, 16,000 in 1990, and more than 23,000 in 2005. This was accompanied by a steep increase in investment from Rs. 2.25 billion (approx. $250 million US) in 1973, to Rs. 45 billion (approx. $1 billion US) in 2002–03. The prices of the most advanced drugs dropped significantly in India, leading the Indian pharma sector to become more competitive while remaining extremely cost effective in the global market.
Copolymerized PEGlyated Acrylate Hydrogels for Delivery of Dicolofenac Sodium
By Sulekha Bhadra , Dipankar Bhadra , Govind Prasad Agrawal
Hydrogels are biocompatible drug delivery systems by which the physical properties can be controlled by the cross-linking density. Hydrogels were prepared by copolymerization of acrylic acid monomers in the presence of poly(ethylene glycol)(PEG) to form polyethylene diacrylate (PEDGA). Various molecular weights of PEGs were used for the synthesis of PEGDA to study the effect of molecular weight of PEG on the properties of hydrogels. These hydrogels were further characterized for free water, swelling behavior, water diffusion, drug loading, and drug release profile. By analyzing the swelling behavior and release pattern of the hydrogels, the authors show that these systems can be suitably used for controlled delivery of drugs.
The Effect of Core and Coating Composition on Drug Release from Directly Compressed Time-Controlled Release Tablets
By Shilpa P. Chaudhari , Praveen D. Chaudhari , Chetan J. Mistry , Manohar J. Patil , Nilesh S. Barhate
The authors prepared and tested press-coated tablets with various weight ratios of ethylcellulose to hydroxypropylcellulose (HPC) and various ratios of two different batches of HPC as an outer coating shell and fillers in core tablets. The tablets were examined for changes in time lag and release patterns of salbutamol sulfate.
Qualification, Validation, and Verification
By David A. Porter
This article considers the distinction among the terms qualification, validation, and verification in the context of pharmacopeial usage.A recommendation for a standardized usage of the terms validation and verification is provided,and general requirements for validation and verification activities are given.The article also emphasizes the importance of knowing when validation or verification is necessary relative to the use of a method to satisfy pharmacopeial article requirements (for which a monograph exists in the pharmacopeia) or for nonpharmacopeial use.
Near-Infrared Assay and Content Uniformity of Tablets
By Robert Mattes , Denise Root , Om Anand , Maria Gerald Rajan , Namrata R. Trivedi , Wen Qu , Yingxu Peng , Yichun Sun
Near-infrared (NIR) assay and content uniformity of tablets provide fast, accurate means of monitoring tablet production that are in step with FDA's process analytical technology initiative.The authors discuss the process for testing a newly released NIR tablet analyzer to determine instrument precision and accuracy using chlorpheniramine maleate tablets.The data show promising results that could relieve laboratory workload of high-performance liquid chromatography analysis and bring analysis closer to real time for process monitoring.
Qualification Results of a New System for Rapid Transfer of Sterile Liquid through a Containment Wall
By Benoît Verjans* , Jacques Thilly , Hartmut Hennig , Patrick Evrard , Christian Vandecasserie
Manufacturers use various techniques to transfer sterile liquid. Some methods, however, cannot accommodate disposable equipment, and others cannot transfer through barriers. This article describes a new approach for aseptic fluid transfer that was developed to provide a high-quality aseptic connection and simplify passage through a wall. The authors discuss the product-qualification results for the approach, which show that the technology and its various components meet pharmacopeial product-qualification requirements.
Acceptable Analytical Practices for Justification of Specifications
By Paul Kurtulik , Ernest Parente , Terrence Tougas , Paul Tsang , Edward Warner , William Winter , Jean M. Wyvratt
The concept of Acceptable Analytical Practices (AAPs) was developed by the Analytical Technical Group of the Pharmaceutical Research and Manufacturers of America to share information about how the pharmaceutical industry has implemented chemistry, manufacturing, and controls and quality guidances of the International Conference on Harmonization and worldwide regulatory authorities. The AAP process identifies and addresses critical issues in which guidance is lacking, ambiguous, or contradictory. AAPs were designed to provide a forum where one could learn from the experience of experts in pharmaceutical analysis and enhance the understanding of analytical practices that reflect good science and sound regulatory compliance. This article summarizes the discussion points from a meeting regarding the Justification of Specifications topic.
Book Review
A Solid Contribution to Spectroscopy
By Steve Doherty
A wealth of citations helps illustrate the applicability of the analytical methods and also highlights their pitfalls.
Washington Report
Down with Supplements!
By Jill Wechsler
FDA is buried in postapproval manufacturing submissions and seeks to reduce the scope of changes that require agency scrutiny.
Packaging Forum
RFID Moves Forward
By Hallie Forcinio
Many radio frequency identification projects are moving beyond the pilot stage, supported by new hardware and software tools.
Outsourcing
Project Managers in the Spotlight
By Jim Miller
Strong demand is straining service providers' project-management capabilities; Patheon receives a much-needed cash infusion.
Agent-In-Place
Labeled a Disaster
By Control, a senior compliance officer
Mishaps in packaging labels serve as a reminder: the recall is in the details.
Viewpoint
USP Chapter Emphasizes Problems With Revision Process
By Dr. Herbert Prince , Dr. Daniel L. Prince
Inaccuracies in Chapter ‹1072› of the current USP 29 reveal problems in USP's revision and proofreading process.
Guest Editorial
Life-Science Biotech Growth Strategies: Cultivation and Regulation In Today's Global Marketplace
By RJ Palermo
To effectively grow in the biotech industry, companies must develop multiphase plans that focus on regulation and efficiency.
In the Field
April 2007
BIO Raises Concerns About Studies on Follow-On Biologics; Green Chemistry Reduces Costs and Waste; Novel Polymer–DNA Delivery System; WHO Stresses Lack of Capacity for Pandemic Flu Vaccine; EGA Concerned About Regulatory Workload in Approving Generics

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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
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