Technology solutions
In many regions it is difficult to consistently monitor the factors that can influence drug degradation, but technology can
help pharma manufacturers, distributors and others involved in the supply chain to screen products to determine if they are
potentially substandard.
One of the most common technologies used today — besides laboratory testing — is the Global Pharma Health Fund's Minilab,
which is used across 70 countries worldwide and leverages four types of tests to identify poor quality products. Pharmaceuticals
containing less than 80% of the API will not pass the test. At just under $10000, Minilabs are relatively affordable, but
require potable water, electricity and a conditioned-controlled environment where the testing is conducted.
Another option is spectroscopy, which has gained considerable momentum since becoming available in portable, handheld instruments.
There are several technologies that use spectrometry, but I will focus on infrared (NIR) and Raman spectroscopy in particular
because these techniques exist in handheld formats and don't require contact with a sample.
NIR is a well-known spectroscopic technique that measures molecular vibrations to identify individual chemical components
of a drug or raw material. NIR requires an investment of manpower to create and maintain robust material libraries, but provides
quick, reliable results once properly installed. It also has the advantage of not requiring contact with a sample. Compared
with Raman spectroscopy, however, it has the disadvantage of being less selective and of requiring more up-front development
work to build robust reference libraries.
Raman spectroscopy is less well known than NIR, but is becoming more popular because it is available as a portable, handheld
instrument. These instruments can be used essentially by anyone because they quickly identify chemical components without
coming into direct contact with the substance. In other words, handheld instruments can scan through sealed glass, plastic
bottles, bags and blister packs at ports of inspection or any other place in the supply chain using a laser that illuminates
a sample and measures the molecular shift. Handheld Raman spectroscopy is currently being used by a number of large pharmaceutical
manufacturers, as well as regulatory bodies worldwide.
Conclusion
Pharmaceutical degradation may not have the visibility of counterfeiting, but it still poses a potential threat to patients
and must be considered by pharma companies. Technology, however, can help ensure that substandard materials are removed from
the supply chain and kept out of the hands of patients. Handheld Raman instruments represent a simplistic solution.
Duane Sword is vice president of Thermo Scientific's Portable Optical Analysis business unit.
References
1. J. Harris, P. Stevens and J. Morris, Keeping it real: combating the spread of fake drugs in poor countries (International
Policy Network, May 2009).
2. P. Gumbel, "How to Stop the Counterfeit-Medicine Drugs Trade", Time (October, 2009).
http://www.time.com/
3. FiercePharma Manufacturing, "Potency drops investigated in H1N1 vaccines" (January 2010).
http://www.fiercepharmamanufacturing.com/
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