Abstract
In an effort to promote the availability of safe and effective drugs, the US Food and Drug Administration is developing spectroscopic methods to assess the quality of drugs in the field. Here we report a rapid screening classification method for Tamiflu (oseltamivir phosphate) capsules using a portable Raman spectrometer to perform screening on three solid oral dosage strengths of Tamiflu, 30 mg, 45 mg and 75 mg. Tamiflu is an antiviral drug that is stockpiled for use in the event of pandemic influenza outbreak. The qualitative classification methods reported were developed using the Raman spectra of intact capsules. The classification algorithms used were able to reliably distinguish the three dosage strengths of Tamiflu. These qualitative models are validated with additional Tamiflu samples from different batches and simulated counterfeits of Tamiflu. The probability that a test sample belongs to each dosage strength class is calculated, and strict class predictions are used to assign each sample to a particular class. The classification methods reported here enable development of user-independent, field-deployable methods for finished drug products and are able to correctly assign 92% of the validation samples using authentic Tamiflu and 100% of the simulated counterfeits.
Highlights
Antivirals are considered priority medicines since they play an important role in controlling pandemic outbreaks and are stockpiled by governments across the world [1]
The validation set consisted of 12 authentic Tamiflu samples—four capsules for each dosage strength, using a different box of Tamiflu from those used in the calibration set and the 20 simulated counterfeit samples including authentic Tamiflu capsule shells that had been refilled with different contents and amantadine and acyclovir capsules which are common antiviral drugs and the former is used to treat influenza
The Raman spectra of the 30 mg, 45 mg, and 75 mg authentic Tamiflu capsules are shown in Figure 1(a), along with the Raman spectrum of pure oseltamivir phosphate API
Summary
Antivirals are considered priority medicines since they play an important role in controlling pandemic outbreaks and are stockpiled by governments across the world [1]. The development of rapid screening tools to assure that stockpiled medicines are authentic is important in light of recent reports of infiltration of counterfeits in the antibiotic and antiviral supply chain [2]. D. Rodriguez of seasonal influenza, antiviral drugs— solid oral dosage forms—can be stockpiled by governments for use in the event of an outbreak years in advance. Of the antiviral drugs available to combat influenza, Tamiflu is the most common. As of 2009, Tamiflu comprised 40 million of the 50 million regimens available in the strategic national stockpile [1]. The outbreaks of swine influenza A (H1N1) in 2009 highlighted the importance of emergency preparedness in the event of pandemic influenza. Tamiflu counterfeits have been found to contain antibiotic and analgesics instead of the approved active ingredient, oseltamivir phosphate
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