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Official websites use. Share sensitive information only on official, secure websites. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. The EU Falsified Medicines Directive states that falsified medicines do not only reach patients through illegal routes but also via the legal supply chain. Falsified medicines can contain harmful ingredients. They can also contain too little or too much active ingredient or no active ingredient at all. The resulting acoustic spectrum is unique and intrinsic to the sample and can be used as an identifier or signature profile. BARDS was evaluated in this study to determine whether a product is falsified or genuine in a rapid manner and at lower cost than many existing technologies. A range of genuine and falsified medicines, including falsified antimalarial tablets from south-east Asia, were tested, and compared to their counterpart genuine products. Significant differences between genuine and falsified doses were found in their acoustic signatures as they disintegrate and dissolve. Principal component analysis was employed to differentiate between the genuine and falsified medicines. This demonstrates that the tablets and capsules included here have intrinsic acoustic signatures which could be used to screen the quality of medicines. The increase in substandard and falsified SF pharmaceutical products is an increasing global issue. It has become increasingly clear, however, that it is a significant problem in developed countries also 6 — 9. Up until there was no consensus international definition of falsified medicines However, recently the World Health Organization defined substandard medical products as those authorized medical products that fail to meet either their quality standards or their specifications 3. It defines unlicensed medical products as those which have not undergone evaluation or approval for the market in which they are distributed, subject to permitted conditions under national or regional regulation and legislation. Falsified medical products are defined as those products which deliberately misrepresent their identity, composition or source. Falsified medicines can include correct or incorrect ingredients, a lack of sufficient ingredients or falsified or misleading packaging 3. There has been a significant and dramatic apparent increase in the number of falsified medicines detected. In , there were incidents of falsified medicines detected whereas in , there were incidents identified by the Pharmaceutical Security Institute 5. The WHO estimated that up to , young children die each year from pneumonia after treatment with substandard or falsified antibiotics 3. In Africa and Asia, substandard and falsified antimicrobial medicines represent a huge but neglected challenge to public health. The prevalence of falsified medicines has been documented in many studies 3. Antimicrobial medicines have been the most extensively investigated class due to the significant prevalence of infectious diseases in these regions. Falsified lifestyle medicines such as phosphodiesterase type 5 PDE-5 inhibitor drugs sildenafil citrate Viagra , tadalafil Cialis and, more recently, vardenafil hydrochloride Levitra , are very frequently falsified and detected globally This is largely due to the growth and ubiquitous use of the internet. Fraudulent websites have proliferated whereby any individual can easily and anonymously purchase prescription-only medicines; the purchaser is responsible for illegal purchase of these products. The techniques used for detection and analysis of SF medicines are numerous. Gas chromatography, nuclear magnetic resonance, liquid chromatography LC coupled with mass spectrometry MS or UV-spectrophotometry detectors, colorimetry, thin layer chromatography, and capillary electrophoresis are all examples of these techniques 12 , Some, such as LC—MS or gas chromatography require laboratory environments and highly trained operators, whereas portable techniques based on innovative technology such as Raman and near-Infrared spectroscopy can be used for field screening of medicines as they are quick and require little or no sample preparation. These techniques range from Raman spectroscopy, X-ray powder diffraction, near infrared spectroscopy, to Fourier transform infrared spectroscopy The significant costs involved in detecting and intercepting falsified and substandard medicines may be prohibitive, especially for countries with low health expenditure, making the implementation of systematic and global measures to combat this problem inadequate. The operation of apparatus and its continuing maintenance to ensure accurate results is another problematic issue. BARDS is a simple dissolution based test that generates a unique acoustic spectrum for a given sample. It offers the ability to monitor and characterise the unique disintegration during dissolution of tablets and blends based on their acoustic spectrum when dissolved in a solvent Much effort has been targeted at improving the security features of packaging or embedding coatings with tracer materials However, the dissolution process of a tablet has an intrinsic acoustic profile and is a powerful signature of the product which falsifiers cannot yet mimic. The unique acoustic profiles are due to changes in the compressibility of a solvent during dissolution which produces the BARDS signal. The speed of inducted sound in a vessel containing the solvent and formulation is reduced, resulting in frequency changes within the solution. The speed of sound v in a solvent is determined by Eq. Generation of gas bubbles in a liquid decreases the density in a negligible way in comparison to the large increase in compressibility. The net effect is a significant reduction of the sound velocity in the dissolution medium. Equation 2 demonstrates the relationship between the fractional gas volume and the speed of sound in water as derived by Frank Crawford The factor 1. Equation 2 was also independently derived in by Wood The fundamental resonance mode, excited by tapping the stirrer bar against the inner wall of the dissolution vessel is measured using a microphone. The fundamental resonant frequency is determined by the sound velocity in the liquid and the approximate but fixed height of the liquid level, which corresponds to one quarter of its wavelength. The resonant frequency response is explained as;. The total volume of the gas is due to entrained gas, gas due to oversaturation, and gas escaping the solvent due to elimination at the surface or reabsorption. The aim of this research is to test whether BARDS has the ability to distinguish between genuine and falsified medicines from diverse sources. Different pharmaceutical formulations were analysed. Method development was carried out on falsified and genuine tablet and capsule formulations to obtain a unique signature for genuine formulations. It is shown that the signatures of the falsified formulations significantly differed from the genuine, thus showing the potential of BARDS as a rapid screening tool. It consists, as described by Ahmed et al. There is access at the front to the dissolution vessel and at the top in order to place a sample in a weighing boat on a tipper motor for introduction of the formulation. The microphone is positioned above the top of the glass within the housing. The glass, containing 25 mL of solvent is placed on the stirrer plate. The stirrer motor underneath is positioned so as to allow the magnetic stir bar to gently tap the inner glass wall with stirring rate at rpm. In this way, the stir bar acts as a source of broadband acoustic excitation, thereby inducing various acoustic resonances in the glass, the liquid and the air column above the liquid. The resonances of the liquid vessel are recorded in a frequency band of 0—20 kHz. A External view of the BARDS instrument and B Tipper motor with a powder sample in a weighing boat ready for addition to the stirred solution below The following falsified and genuine medicines were received from GlaxoSmithKline plc GSK ; Augmentin amoxicillin-clavulanic acid mg tablets, Panadol Extra paracetamol mg-caffeine 65 mg tablets, Alli orlistat 60 mg capsules, Zentel albendazole mg tablets, Clamoxyl amoxicillin mg capsules. Artesunate tablets were a common treatment for Plasmodium falciparum malaria when collected but are no longer recommended as first line treatment and have been superseded by co-formulated artemisinin-based combination therapy. Amoxicillin-clavulanic acid coformulation and amoxicillin are commonly used antibiotics, albendazole is used to treat a broad range of parasitic worm infections, paracetamol is an analgesic and orlistat is a weight loss medicine indicated in overweight adults. The falsified antimalarial samples were purchased in Vietnam in January see Table 1 , and although were long past the stated expiry date at the time of analysis, they were stored in a fridge and were in apparent excellent condition They were labelled, falsely, as made by Guilin Pharmaceutical Co. Genuine tablets labelled as made by Guilin Pharmaceutical Co. Antimalarial tablets, stated as containing 50 mg artesunate labelled as Artesunate and made by Guilin Pharmaceutical Co. Ltd and were obtained in Vietnam The artesunate stated as 50 mg tablet samples were received in their original blister packs and stored in plastic bags and were visually identical. Samples were tested initially in deionised water but a clear spectrum for some samples were not achievable due to low solubility. The artesunate samples produced data with greater reproducibility using 0. Thus, 0. All artesunate samples measurements were carried out in duplicate. In a typical BARDS analysis, the spectrometer records the steady state resonances of the system as a background reference for 30 s, before the sample is added and the stirrer is set in motion. The pitch of the resonance modes in the solution change significantly when the sample formulation is added before gradually returning to steady state over several minutes 30 , The received samples were of different formulations. Therefore, method development was carried out on each formulation in order to find the best method to run the samples. Amoxicillin-clavulanic acid tablets were crushed and mg of powder tested. Amoxicillin powder mg was removed from the amoxicillin capsules. The tablets of artesunate were cut into halves using a pill cutter obtained from Safe and Sound Health. The entire content of orlistat and amoxicillin capsules were tested for each individual experiment. All samples were tested using 25 ml of solvent of either deionised water or 0. Figure 2 A shows the visual similarity of genuine and falsified Alli orlistat capsules. The only observed visual difference is the dark blue indigo band that is thicker in the falsified capsule compared to the genuine one. The genuine capsule weight was 0. Also, it was noticed that when attempting to open the capsules, the falsified capsule had a low-quality shell and more easily broke into fragments compared to the genuine capsules. The content of the genuine and the falsified capsules were approximately 0. Figure 2 B represent BARDS data of a mg powder sample of genuine and falsified orlistat formulations in deionized water. The dissolution of the whole capsules shell included of both genuine and falsified capsules did not yield clear spectra due to the lack of solubility of the shell in water. A an image of genuine and falsified Alli orlistat capsules. It then returned to steady state at s, producing a V-shape spectra. The V-shape indicates a rapid evolution of gas followed by slower loss of gas until equilibrium is reached. On the other hand, falsified capsule content produces an insignificant effect on the frequency due to lack of evolution of gas bubbles being produced. Figure 3 A is an image of the genuine and falsified amoxicillin-clavulanic acid tablets. Both tablets showed different visual characteristic such as the embossed letter on the fake tablet that was different from the genuine one. The falsified tablet also had a score line down the centre. Both tablets were crushed into homogenous powder and mg were dissolved in deionised water. The genuine sample produced BARDS spectra black profile that can be distinguished from the falsified sample spectra red profile in Fig. The genuine dissolution profile returned to steady state at s while the falsified sample returned to steady state at s. The data of both samples in Fig. A An image of genuine and falsified amoxicillin-clavulanic acid tablets. B BARDS profile of mg of genuine and falsified amoxicillin-clavulanic acid powder dissolved in 25 ml of deionised water. Both genuine and falsified capsules of amoxicillin were alike with almost no visual differences as shown in Fig. The mean measured weight of falsified and genuine capsules were 0. The powder capsule content was yellowish for the genuine and white for the falsified sample. A An image of genuine and falsified amoxicillin capsules. Note the falsified data is a single replicate due to the powder being insoluble. BARDS testing of genuine and falsified amoxicillin was performed using mg of capsule powder content and deionised water. Only a single replicate of the falsified powder was attempted. This is due to the capsule content being insoluble and floating on the surface of the solution deionised water. The falsified amoxicillin powder generated no gas upon its addition to the solvent. This behaviour is opposite to that of the genuine product, therefore, producing additional evidence of falsification. The font size of the embossed letters on the falsified tablet was slightly larger than that of the genuine tablet. The black profile in Fig. The f min of the genuine sample profile was 8. Figure 6 A shows that genuine and falsified tablets of albendazole appeared identical in shape and other visual features and the mean weight for both tablets were almost the same 0. A An image of genuine and falsified albendazole tablets. A statistical difference between the BARDS dissolution profiles of the genuine tablets black profile and the falsified tablets red profile is shown in Fig. There is a plateau for approximately s at f min with no return to steady state by the end of the experiment. Samples G and G resonant volume lines are absorbed no longer resonant after the addition of the samples and became briefly undetectable, however, the spectra became detectable once more at 77 s and 40 s, respectively. There was good intra-sample correlation indicating good reproducibility. A BARDS profiles of three batches of genuine artesunate tablets manufactured on different dates, dissolved in 25 ml of 0. All three genuine tablets returned to steady state before the end of s run time while the BARDS profile of falsified artesunate tablets extended to s. Upon addition of the falsified artesunate sample at 30 s the frequency dropped to 6 kHz and levels off for approximately s. The bulk excipient for genuine tablets is most likely starch but calcium carbonate for the falsified The BARDS profile of this sample shows large error bars which may indicate inconsistency of the sample formulation. The BARDS profile indicates that high compression force may have been applied to the production of this fake tablet. The time region from to s was used to compare between all the artesunate tablets with linear interpolation used to ensure direct time point comparison. Figure 9 A shows the region of comparison across all the artesunate tablets. The difference between the profiles is mostly distinguished according to the PC1 score shown as t1 on the graph. A horizontal dashed grey line is shown in Fig. Typically, a larger or more representative data sets of genuine artesunate tablets would be required to clearly define such a threshold or distance measure in PCA space. B Principle component scores plot for first t1 and second t2 principle components, the dashed grey line highlights a potential threshold value to distinguish between genuine and falsified artesunate tablets. BARDS profile data of artesunate tablets clearly differentiates between the genuine and falsified tablets. None of the falsified samples have similar acoustic profiles to one another or to the genuine product as demonstrated in Figs. This is conclusive evidence of falsified product detection, whereas the genuine product made 8 years apart, have very similar BARDS profiles and PCA scores. Notably some of the falsified samples also fail to return to steady state by s. BARDS was shown to differentiate between genuine and falsified samples of diverse medicines. This represents a rapid approach to screen suspect medicines using genuine products as a reference control. BARDS represents a promising new, simple, cost-effective and rapid approach to discriminate between genuine medicines and falsified medicines, taking just 5 min or less. There are no costly reagents or consumables required. A reusable weighing boat can be used. There is no maintenance required apart from daily cleaning. It takes just a few minutes to clean the vessel with water between samples before proceeding with the next sample. An unskilled operator could be trained in less than an hour to process a sample and to identify a falsified product compared to a reference spectra in a database. Alternatively, the spectral profile can be analysed, in part or in full, by multivariate techniques such as PCA, to easily and rapidly differentiate between the genuine and falsified medicines. BARDS data illustrates that genuine medicines have unique signatures which are not mimicked by fake medicines included in this proof of principle. It does not focus on API content as other techniques do. Instead, it tracks unique disintegration and dissolution processes of the whole tablet or powder. The BARDS response is dependent on several factors including the excipients, the blend ratio, the compression force used to make the tablets and even the speed at which the blend is conveyed during processing These parameters contribute to the quality attributes of a tablet or lack thereof. The multi-factorial contributions to a BARDS response are responsible for the intrinsic and unique spectrograms which can be harnessed as a tool to differentiate. Some formulations are susceptible to degradation for a variety of reasons. These changes could potentially also be tracked. It could also be used to determine formulations from the same source as a presumptive test. Products made by the same manufacturer but marketed under different brand names in different regions also display matching BARDS spectra Figure 3 B indicates slow disintegration and return to steady state of the amoxicillin-clavulanic acid falsified tablets. The same can be said for the profile of the genuine tablet in Fig. This slow return to steady state is possibly due to the presence of magnesium stearate which is used as a lubricant. Magnesium stearate slows the hydration process, thus delaying the rate of the equilibrium process These studies have shown how coating erosion, disintegration, deaggregation and dissolution can be mapped onto a BARDS spectrum. In Fig. This may be an indication of excessive compression force being used in the production of these falsified tablets, leading to prolonged disintegration and less trapped air as indicated by the increased value of f min. Also, the use of hydrophobic materials can affect the return to steady state frequency. Conversely, powders that have faster wetting rates have a faster return to steady state 30 , There tends to be less disintegrant used in falsified tablets compared to genuine. This may indicate that the blend uniformity is less than that of the genuine tablet. The increased f min value for the falsified tablet may also indicate an increased compression force was used to make the tablet which leads to less voids between particles, thus less trapped air The relatively slight variation in spectra between genuine artesunate in Fig. G and G samples returned to steady state at almost the same time while G took longer to disintegrate with later return to steady state. This could be due to the slight variation in compression force used in production. Also, the stability of the three samples and the wide range of manufacture and expiry dates could have caused BARDS profile variation. G, G and G were manufactured in , and , and had expiry dates of , and , respectively. The plateau in Fig. Also, the BARDS profiles suggest that a larger compression force applied during the manufacturing process of these falsified tablets. This may explain the prolonged disintegration of this tablet during BARDS tests, which lasted for s with no return to steady state frequency. High compression force would reduce the voids between particles which leads to longer hydration process times. Also, poor wettability of substances used in this formulation could have caused the delay observed in the BARDS profile. These differences may also be due to different compression forces being applied in the production of the tablets as well as different formulation processes and materials being used. This may be a result of using a greater mass of sample. This is confirmed by the measured weight of the whole tablet which was 0. Generally, varying frequency minima in the spectra, as well as the time taken to return to steady state of the system are all indicators as to whether the material being tested is authentic or falsified when compared to the genuine medicines. The PCA analysis employed for the artesunate tablets in Fig. The genuine tablets were distinguished by a high score value in t1. Falsified tablets could be immediately distinguished by a low or negative score in t1 as well as lager values in t2. The ability to easily identify differences and similarities between falsified tablets may be a desirable output of multivariate BARDS data analysis. With the availability of larger or more representative data sets of tablets or capsules, thresholds and distance measure in PCA space can also be used to clearly identify acceptable variation for genuine tablets or capsules, making them readily distinguishable from their falsified counterparts. Substandard medicines, both due to within-factory errors and due to degradation in supply chains, are expected to produce different BARDS spectra compared to control spectra with the correct formulation. Small percentage changes of the excipients can cause statistical changes in the spectra Future work will investigate a broader range of pharmaceutical products with different quality profiles to produce a larger statistical dataset of genuine and falsified medicines in an on-line reference library. It could provide on the spot testing of suspect products coupled with cloud internet access in remote areas to a spectral database in post-market surveillance for the objective selection of samples for formal reference laboratory analysis. One limitation of BARDS is the need for authentic reference signatures for the wide diversity of brands available on the market. Limitations of the study include that only a few API were tested, out of the many thousands in use globally, and we did not include fixed-dose co-formulated medicines. We did not examine the influence of batch to batch and brand variation and degradation on acoustic profiles. Optimisation of solvent used for diverse APIs and understanding of the appropriateness of the technique for fat-soluble drugs remains to be determined. Although a neglected area of research, many of those who have investigated medicine disintegration and dissolution issues, have found evidence of major impairments. Disintegration tests are often used in screening, such as that available in the portable GPHF-Minilab, but are infrequently followed by laboratory-based dissolution tests. Traditional disintegration only tests part of the process of drug release and has poor prediction to identify samples with extreme dissolution failure The disintegration testing in the GPHF-Minilab kit is thus not an appropriate proxy for dissolution testing. Only two of the 25 antimalarial samples that failed dissolution testing failed the GPHF-Minilab disintegration test. The portfolio of medicine quality screening devices would greatly benefit from reliable portable screening device for assaying dissolution. Although more investigations are needed, BARDs looks-like a promising candidate for this purpose. Patients or the public were not involved in the design, or conduct, or reporting, or dissemination plans of our research. All data relating to the study is contained in this article. Anas Alfarsi has been gratefully funded by the Saudi Ministry of Education. All other authors confirm no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years, no other relationships or activities that could appear to have influenced the submitted work. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. As a library, NLM provides access to scientific literature. Sci Rep. Find articles by Anas Alfarsi. Find articles by Garry Fawbert. Find articles by Simon Lawrence. Find articles by Arjen Dondorp. Find articles by Paul N Newton. Find articles by Dara Fitzpatrick. Received Aug 8; Accepted Apr 26; Collection date Open in a new tab. Sample code and type Packaging type Blister batch no. Publisher's note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Similar articles. Add to Collections. 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Fatalities grow as people use cheap but worthless 'drugs' : Fake malaria pills haunt Asians

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Guilin Pharma has received its first WHO product quality certification for the anti-malaria drug Artemether, paving the way for other drugs in its portfolio. Artemether is an anti-malarial drug for the treatment of multi-drug resistant strains of Plasmodium falciparum. The subsequent inspection schedule was then confirmed with WHO on May 16th, Source: Fosun Pharma. Disclaimer: This article does not necessarily reflect the views of AsianScientist or its staff. The magazine is published by Singapore-headquartered Wildtype Media Group. Key supercomputing leaders discuss prospects, progress and possibilities in Asia-Pacific and beyond. As more heatwaves sweep through Southeast Asia, outdoor workers are confronted with an increased risk of deaths, disabilities and health issues in the region. Asian Scientist Newsroom. Related Stories from Asian Scientist Academia. In the Lab. Top News. Too Hot To Work As more heatwaves sweep through Southeast Asia, outdoor workers are confronted with an increased risk of deaths, disabilities and health issues in the region.

Buying MDMA pills Guilin