Counterfeit Drug Detection: Help Is at Han

According to the FDA, 10% of drugs in the world are counterfeit. The World Health Organization (WHO) takes a more nuanced view: according to the organization, less than 1% of drugs in developed nations are counterfeit, but 10% of drugs in developing economies are counterfeit. However, in parts of Latin America, Southeast Asia and sub-Saharan Africa, more than 30% of the drugs on the market are counterfeit. While this problem is obviously worst in the developing world, more consumers in developed countries are beginning to be exposed through internet pharmacies. As a response to the rising trend, the FDA established the Counterfeit Drug Task Force in 2003. WHO, which has been fighting drug counterfeiting for decades, announced the International Medical Products Anti-Counterfeiting Taskforce (IMPACT), a collaborative plan among all of WHO’s member nations to combat worldwide drug counterfeiting. While some solutions call for RFID chips and increased sophistication in the printing of labeling and packaging, these approaches do not allow the drugs themselves to be analyzed. Molecular spectroscopic methods are commonly used to detect counterfeit drugs by determining their chemical structure. In January 2006, Bruker Optics reached an agreement with the Chinese State Food and Drug Administration to sell more than 300 Fourier-transform near-infrared (FT-NIR) spectrometers to help fight China’s problem with counterfeit drugs (see IBO 2/28/06). The spectrometers are based in vans for mobile deployment. Benchtop molecular spectroscopic systems have been successful in this application, but in the effort to stop counterfeit drugs from entering the market, it is necessary to be able to determine a drug’s authenticity in the field. To meet this demand, two companies have recently introduced portable molecular spectroscopic products designed for detecting counterfeit drugs. In January, Analytical Spectral Devices debuted the RxSpec 700Z, a near-infrared (NIR) spectroscopy-based device. In the same month, Ahura Scientific announced the availability of TruScan, a Raman spectroscopy-based offering. The benefits of Raman and NIR spectroscopy are similar. They are both capable of delivering fast results—the RxSpec 700Z can provide authentication results in one to two seconds and the TruScan can determine the chemical validity of a given drug in approximately 30 seconds. In addition, neither technique requires sample preparation, and neither one will destroy its sample. The RxSpec 700Z measures 18 x 12 x 5 in., about the size of a large briefcase, and contains a touchscreen computer with an updatable library of drugs’ “spectral fingerprints.” After placing the sample in its receptacle, the user selects the reference from this library and the sample to be tested is authenticated by comparing its NIR spectra to the 700Z’s reference. The Ahura Scientific TruScan is a handheld device that measures 12 x 6 x 3 in. and weighs less than four pounds. Authentication on the TruScan is done by holding the sample close to the TruScan’s laser aperture; an optional tablet holder and FlexProbe fiber-optic extension allow for a variety of testing situations. If a sample fails authentication, the TruScan offers the option of determining the identity of the anomalous substances in the sample. Both products allow their drug libraries to be quickly updated as the needs of a given project change. The price for the TruScan is between $40,000 and $60,000, depending on the variety of accessories and services purchased. The price for the RxSpec 700Z has not yet been announced. In both cases, the companies employed technology that had previously been used in other incarnations. Analytical Spectral Devices markets the RxSpec 700Z’s larger predecessors, the RxSpec and the RxSpec-High Volume, to mail-order and central fill pharmacies. Bringing the technology of a benchtop system to a configuration that can fit into a briefcase required a number of changes. “The most critical [challenge] was how to present the sample in the sample window so that it allowed the maximum flexibility for the user and gained the maximum accuracy of prediction,” explained Michael Lands, director of Business Development at Analytical Spectral Devices. Ahura’s first handheld spectroscopic product on the market was the Raman-based FirstDefender, released in 2005 (see IBO 8/15/06). As Doug Kahn, chairman and CEO of Ahura Scientific, explained, the TruScan grew from interest in the FirstDefender: “We began to expose our technology at trade shows about a year and a half ago and while we had directed our initial technology to the safety and security markets, we found some substantial interest from the pharmaceutical industry.” The pharmaceutical companies also expressed interest in the capabilities of Raman spectroscopy as a means of verifying the purity of raw materials during the pharmaceutical manufacturing process. While the hardware needed for the TruScan was already available, the software to interpret the Raman spectra had to be drastically changed. Christopher Brown, director of System Analytics and Applications for Ahura Scientific said that conforming to the FDA’s standards required major alterations: “some of the biggest changes were that it had to be conducive to 21 CFR Part 11 compliance.” Dr. Brown added that significant software changes had to be made in order to make the jump from chemical identification to chemical authentication. One advantage of the Raman technology in the Tru­Scan is that it is capable of scanning drugs while they are still in their containers or blister packs. While the RxSpec 700Z has not been tested for scanning through blister packs that drugs in Europe are usually packaged in, Mr. Lands stated that adding that capability would be more or less a matter of calibration. “We have done drug verification in blister packaging on another application, so we know it can be done successfully . . . [a] key issue is correctly accounting for the variances in the blister packaging so that we can discriminate between the packaging and the drug of interest.” In the case of the RxSpec 700Z, Analytical Spectral Devices has been able to harness one of the inherent difficulties of NIR spectroscopy and use it to an advantage. NIR spectroscopy yields very broad spectra, which must be analyzed with complicated algorithms. However, this excess of information can supply a great deal of chemical information about a given drug sample: “[NIR spectroscopy] turns out virtually all of the ingredients in drugs. Both active ingredients and excipients [a drug’s inactive ingredients] have NIR absorption features, while there is a more limited set of ingredients that are Raman active. This allows NIR to measure nearly all of the product and analyze the spectral fingerprint, not just the active portion of the drug.” Raman spectroscopy excels in its “exquisite selectivity,” according to Dr. Brown of Ahura. Both companies are aware of the global nature of the drug counterfeiting problem, and have hopes that their products will be successful both in the US and abroad. “We see this product as a global product. Pharmaceutical companies are located worldwide and counterfeiting occurs in every corner of the world,” Mr. Lands said. Mr. Kahn was equally confident about the future success of the TruScan around the world. “In the short run, we could see a stronger uptake in the US market simply because there’s funding and there’s a higher level of regulatory review. By the same token, the problems are worse in other countries and so there could be a quicker uptake there because of the severity of the issue.” The problem of counterfeit drugs is not likely to abate within the next few years. However, products such as the RxSpec 700Z and the TruScan, and those to come, should prove to be significant weapons in the struggle against drug counterfeiting.

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