scholarly journals Laboratory evaluation of twelve portable devices for medicine quality screening

2021 ◽  
Vol 15 (9) ◽  
pp. e0009360
Author(s):  
Stephen C. Zambrzycki ◽  
Celine Caillet ◽  
Serena Vickers ◽  
Marcos Bouza ◽  
David V. Donndelinger ◽  
...  
Keyword(s):  
Near Infrared ◽  
Colorimetric Assay ◽  
Active Pharmaceutical Ingredient ◽  
Microfluidic System ◽  
Poor Quality ◽  
Laboratory Evaluation ◽  
Regulatory Function ◽  
Portable Devices ◽  
Liquid Chromatograph ◽  
Falsified Medicines

Background Post-market surveillance is a key regulatory function to prevent substandard and falsified (SF) medicines from being consumed by patients. Field deployable technologies offer the potential for rapid objective screening for SF medicines. Methods and findings We evaluated twelve devices: three near infrared spectrometers (MicroPHAZIR RX, NIR-S-G1, Neospectra 2.5), two Raman spectrometers (Progeny, TruScan RM), one mid-infrared spectrometer (4500a), one disposable colorimetric assay (Paper Analytical Devices, PAD), one disposable immunoassay (Rapid Diagnostic Test, RDT), one portable liquid chromatograph (C-Vue), one microfluidic system (PharmaChk), one mass spectrometer (QDa), and one thin layer chromatography kit (GPHF-Minilab). Each device was tested with a series of field collected medicines (FCM) along with simulated medicines (SIM) formulated in a laboratory. The FCM and SIM ranged from samples with good quality active pharmaceutical ingredient (API) concentrations, reduced concentrations of API (80% and 50% of the API), no API, and the wrong API. All the devices had high sensitivities (91.5 to 100.0%) detecting medicines with no API or the wrong API. However, the sensitivities of each device towards samples with 50% and 80% API varied greatly, from 0% to 100%. The infrared and Raman spectrometers had variable sensitivities for detecting samples with 50% and 80% API (from 5.6% to 50.0%). The devices with the ability to quantitate API (C-Vue, PharmaChk, QDa) had sensitivities ranging from 91.7% to 100% to detect all poor quality samples. The specificity was lower for the quantitative C-Vue, PharmaChk, & QDa (50.0% to 91.7%) than for all the other devices in this study (95.5% to 100%). Conclusions The twelve devices evaluated could detect medicines with the wrong or none of the APIs, consistent with falsified medicines, with high accuracy. However, API quantitation to detect formulations similar to those commonly found in substandards proved more difficult, requiring further technological innovation.

scholarly journals Quality assessment of Diflucan® tablets distributed online: Diflucan® distributed online

2021 ◽  
Vol 5 ◽  
pp. 239920262110020
Author(s):  
Tomoko Sanada ◽  
Myu Ohnishi ◽  
Naoko Yoshida ◽  
Kazuko Kimura ◽  
Hirohito Tsuboi
Keyword(s):  
Raman Scattering ◽  
Near Infrared ◽  
Health Hazard ◽  
Active Pharmaceutical Ingredient ◽  
Visual Observation ◽  
The Internet ◽  
Content Uniformity ◽  
Potential Health ◽  
Raman Scattering Spectroscopy ◽  
Falsified Medicines

Background: Falsified medical products have been reported worldwide. Falsified medicines with poor quality are a potential health hazard. Some Internet sites advertise fluconazole (Diflucan®), an antifungal medicine used to treat deep mycoses, as “female Viagra®.” Aim: The aim of this study was to investigate the authenticity and quality of Diflucan® tablets distributed on the Internet. Methods: We ordered Diflucan® tablets via the Internet and evaluated them by visual observation, authenticity investigation, quality evaluation (quantity of the active pharmaceutical ingredient, content uniformity, and dissolution), and near-infrared and Raman scattering spectroscopy. Results: We obtained 11 samples of Diflucan® tablets from all 11 Japanese Internet sites identified in our search. Of 11 sites, 7 advertised fluconazole as having effects on female sexual function. Ten of the Diflucan® samples were confirmed as genuine and one sample was falsified. The genuine Diflucan® samples met the specifications of all quality evaluations. The packaging, size, and color of the falsified Diflucan® sample obtained in this study differed from the authentic Diflucan® tablet. The falsified Diflucan® sample obtained in this study did not contain fluconazole and instead contained what appeared to be sildenafil citrate. The spectra of the falsified Diflucan® tablet obtained in this study differed from the authentic Diflucan® tablet in near-infrared and Raman scattering spectroscopy. Conclusion: We confirmed that one falsified Diflucan® tablet was distributed online. Thus, continued measures against falsified medicines are required.

scholarly journals Assessment of chicken breast shelf life based on bench-top and portable NIR spectroscopy tools coupled with chemometrics

2020 ◽  
Author(s):  
Ilaria Lanza ◽  
Daniele Conficoni ◽  
Stefania Balzan ◽  
Marco Cullere ◽  
Luca Fasolato ◽  
...  
Keyword(s):  
Discriminant Analysis ◽  
Shelf Life ◽  
Meat Quality ◽  
Near Infrared ◽  
Nir Spectroscopy ◽  
Life Assessment ◽  
Chicken Breast ◽  
Portable Devices ◽  
Physicochemical Processes ◽  
Insight Into

Abstract Near-infrared (NIR) spectroscopy is a rapid technique able to assess meat quality even if its capability to determine the shelf life of chicken fresh cuts is still debated, especially for portable devices. The aim of the study was to compare bench-top and portable NIR instruments in discriminating between four chicken breast refrigeration times (RT), coupled with multivariate classifier models. Ninety-six samples were analysed by both NIR tools at 2, 6, 10 and 14 days post-mortem. NIR data were subsequently submitted to partial least squares discriminant analysis (PLS-DA) and canonical discriminant analysis (CDA). The latter was preceded by double feature selection based on Boruta and Stepwise procedures. PLS-DA sorted moderate separation of RT theses, while shelf life assessment was more accurate on application of Stepwise-CDA. Bench-top tool had better performance than portable one, probably because it captured more informative spectral data as shown by the variable importance in projection (VIP) and restricted pool of Stepwise-CDA predictive scores (SPS). NIR tools coupled with a multivariate model provide deep insight into the physicochemical processes occurring during storage. Spectroscopy showed reliable effectiveness to recognise a 7-day shelf life threshold of breasts, suitable for routine at-line application for screening of meat quality.

scholarly journals Quality Assessment of Some Essential Children’s Medicines Sold in Licensed Outlets in Ashanti Region, Ghana

2018 ◽  
Vol 2018 ◽  
pp. 1-14 ◽  
Author(s):  
Grace Frimpong ◽  
Kwabena Ofori-Kwakye ◽  
Noble Kuntworbe ◽  
Kwame Ohene Buabeng ◽  
Yaa Asantewaa Osei ◽  
...  
Keyword(s):  
Quality Evaluation ◽  
Active Pharmaceutical Ingredient ◽  
Poor Quality ◽  
Surveillance Systems ◽  
Ashanti Region ◽  
The United Kingdom ◽  
The Poor ◽  
Medicine Outlets ◽  
Children’S Medicines

The quality of 68 samples of 15 different essential children’s medicines sold in licensed medicine outlets in the Ashanti Region, Ghana, was evaluated. Thirty-two (47.1%) of the medicines were imported, mainly from India (65.6%) and the United Kingdom (28.1%), while 36 (52.9%) were locally manufactured. The quality of the medicines was assessed using content of active pharmaceutical ingredient (API), pH, and microbial limit tests, and the results were compared with pharmacopoeial standards. Twenty-six (38.2%) of the samples studied passed the official content of API test while 42 (61.8%) failed. Forty-nine (72.1%) of the samples were compliant with official specifications for pH while 19 (27.9%) were noncompliant. Sixty-six (97.1%) samples passed the microbial load and content test while 2 (2.9%) failed. Eighteen (26.5%) samples passed all the three quality evaluation tests, while one (1.5%) sample (CFX1) failed all the tests. All the amoxicillin suspensions tested passed the three evaluation tests. All the ciprofloxacin, cotrimoxazole, flucloxacillin, artemether-lumefantrine, multivitamin, and folic acid samples failed the content of API test and are substandard. The overall API failure rate for imported products (59.4%) was comparable to locally manufactured (63.9%) samples. The results highlight the poor quality of the children’s medicines studied and underscore the need for regular pharmacovigilance and surveillance systems to fight this menace.

Polymorphism control of active pharmaceutical ingredients

2021 ◽  
pp. 37-54
Author(s):  
Roman Petrovich Terekhov ◽  
Denis Igorevich Pankov ◽  
Ekaterina Aleksandrovna Anfinogenova ◽  
Irina Anatolievna Selivanova
Keyword(s):  
Active Pharmaceutical Ingredient ◽  
Development Stage ◽  
Poor Quality ◽  
Polymorphic Modification ◽  
High Tech ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Ingredients ◽  
Medicinal Substances ◽  
The Usa ◽  
Economic Union

Рolymorphism is receiving increasing attention due to its influence on the physicochemical and pharmacological properties of the active pharmaceutical ingredients (API) while maintaining the molecular structure. This review is devoted to the problem of APIs phase state control both at the development stage and during the circulation of the drug. The term «polymorphism» has different definitions depending on the branch of science. There is no unambiguous solution to this issue in the regulatory documentation of pharmaceutical industry either. Based on the analysis of literary sources, the article presents a comparison of pharmacopeia methods, recommended in Russian and foreign regulatory documents for the analysis of polymorphism of medicinal substances, including state pharmacopeias of Russia, Belarus, Kazakhstan, the USA, and Japan, as well as international pharmacopeias of the European Economic Union and the Eurasian Economic Union. The trend on using a complex of high-tech equipment is revealed. A systematic approach to analysis based on X-ray diffraction, thermal, spectral, microscopic, biological, and physical methods for determining constants makes it possible not only to identify the polymorphic modification of API, but also to characterize its structure, morphology, physicochemical properties and pharmacological activity. In the Russian Federation, the phenomenon of polymorphism is being studied especially intensively, and some control methods, such as biological methods, are validated only in Russian pharmacopeia. A promising direction for further research is the improvement and harmonization of regulatory documentation within the framework of this chemical and technological field of pharmacy. A global approach will help to reduce not only the probability of poor-quality products entering the market, but also the costs of establishing the authenticity of the active pharmaceutical ingredient produced.

scholarly journals The Brewing Industry and the Opportunities for Real-Time Quality Analysis Using Infrared Spectroscopy

2020 ◽  
Vol 10 (2) ◽  
pp. 616 ◽  
Author(s):  
Glen Fox
Keyword(s):  
Amino Acids ◽  
Infrared Spectroscopy ◽  
Real Time ◽  
Near Infrared ◽  
Processing Parameters ◽  
Production Costs ◽  
Quality Analysis ◽  
Portable Devices ◽  
Brewing Industry ◽  
Brewing Process

Brewing is an ancient process which started in the middle east over 10,000 years ago. The style of beer varies across the globe but modern brewing is very much the same regardless of the style. While there are thousands of compounds in beer, current methods of analysis rely mostly on the content of only several important processing parameters such as gravity, bitterness, or alcohol. Near infrared and mid infrared spectroscopy offer opportunities to predict dozens to hundreds of compounds simultaneously at different stages of the brewing process. Importantly, this is an opportunity to move deeper into quality through measuring wort and beer composition, rather than just content. This includes measuring individual sugars and amino acids prior to fermentation, rather than total °Plato or free amino acids content. Portable devices and in-line probes, coupled with more complex algorithms can provide real time measurements, allowing brewers more control of the process, resulting in more consistent quality, reduced production costs and greater confidence for the future.

scholarly journals Limitations of NIR Spectrometry as an Identification Test for Active Ingredients in Medicinal Products

2021 ◽  
Vol 11 (1) ◽  
pp. 49-54
Author(s):  
N. E. Kuz'mina ◽  
S. V. Moiseev ◽  
B. K. Romanov
Keyword(s):  
Quality Control ◽  
Near Infrared ◽  
Laboratory Evaluation ◽  
Infrared Spectrometry ◽  
Classification Models ◽  
Medicinal Products ◽  
Spectral Library ◽  
Active Ingredients ◽  
Counterfeit Drugs ◽  
Identification Test

Near-infrared spectrometry (NIRS) is a new pharmacopoeial method. It is widely used in the pharmaceutical industry for quality control of medicinal products at various production stages (control of raw materials and finished products), and for detection of substandard and counterfeit drugs.The aim of the study was to assess the feasibility of using NIRS as an identification test for active ingredients during pre-marketing quality control of medicinal products.Materials and methods: 327 drugs samples represented as solid and semisolid dosage forms were tested by NIRS following their examination by well-established pharmacopoeial Identification methods during pre-marketing laboratory evaluation. The NIR spectra of the test samples were compared with the spectral library classification models.Results: NIRS confirmed the identity of 3.1% of the tested medicinal products. It was demonstrated that library classification models could be used for identification of only those medicines that were produced by a specific manufacturer, i.e. for confirmation of medicine identity.Conclusions: the NIRS method is unpractical as an Identification test for active ingredients in medicinal products during the pre-marketing laboratory evaluation stage. The main limitations of NIRS are lack of complete sets of library classification models for all medicinal products available in the market and non-reproducibility of spectral library data obtained with a different instrument.

scholarly journals Rapid Estimation of Potato Quality Parameters by a Portable Near-Infrared Spectroscopy Device

Sensors ◽  
2021 ◽  
Vol 21 (24) ◽  
pp. 8222
Author(s):  
Olga Escuredo ◽  
Laura Meno ◽  
María Shantal Rodríguez-Flores ◽  
Maria Carmen Seijo
Keyword(s):  
Infrared Spectroscopy ◽  
Near Infrared Spectroscopy ◽  
Dry Matter ◽  
Near Infrared ◽  
Reducing Sugars ◽  
Quality Parameters ◽  
Portable Devices ◽  
Calibration Model ◽  
Least Squares Regression ◽  
Potato Quality

The aim of the present work was to determine the main quality parameters on tuber potato using a portable near-infrared spectroscopy device (MicroNIR). Potato tubers protected by the Protected Geographical Indication (PGI “Patata de Galicia”, Spain) were analyzed both using chemical methods of reference and also using the NIR methodology for the determination of important parameters for tuber commercialization, such as dry matter and reducing sugars. MicroNIR technology allows for the attainment/estimation of dry matter and reducing sugars in the warehouses by directly measuring the tubers without a chemical treatment and destruction of samples. The principal component analysis and modified partial least squares regression method were used to develop the NIR calibration model. The best determination coefficients obtained for dry matter and reducing sugars were of 0.72 and 0.55, respectively, and with acceptable standard errors of cross-validation. Near-infrared spectroscopy was established as an effective tool to obtain prediction equations of these potato quality parameters. At the same time, the efficiency of portable devices for taking instantaneous measurements of crucial quality parameters is useful for potato processors.

scholarly journals Research of water extraction from xenoderm as an active pharmaceutical ingredient in drugs

2020 ◽  
pp. 42-50
Author(s):  
Б. В. Павлюк ◽  
Ю. Я. Мельник ◽  
Т. А. Грошовий ◽  
М. Б. Чубка ◽  
В. Й. Скорохода
Keyword(s):  
Amino Acids ◽  
Glutamic Acid ◽  
High Performance ◽  
Water Extract ◽  
Active Pharmaceutical Ingredient ◽  
Chromatographic Determination ◽  
Bound State ◽  
Physicochemical Analysis ◽  
Porcine Skin ◽  
Liquid Chromatograph

Today, burns are one of the most common types of injuries in the home and at work around the world. Therefore, the issue of treatment of burns remains relevant today for medicine and pharmacy in particular. In Ukraine, the method of treatment of burns using xenodermoimplants from porcine skin is used, and therefore the crushed substrate of cryolyophilized porcine skin (xenoderm) is a promising active ingredient in the technology of various drug forms. The aim of the work was to study the structural and mechanical properties of water extract from the crushed substrate of the xenoderm and to determine its amino acid composition by using physicochemical analysis, namely using high performance liquid chromatography (HPLC). A glass pycnometer and a Heppler BH 2 MLW drop ball viscometer were used to determine the density and viscosity of the water extract from the xenoderm. The density and viscosity of the water extract were studied at different temperatures. The dependence of the density and viscosity of the water extract from the xenoderm on temperature was studied and it was found that with increasing temperature the dynamic viscosity decreases and the density changes slightly. A glass pycnometer and a viscometer with falling ball were used to determine the density and viscosity of the xenoderm water extract. Chromatographic separation of amino acids was performed on a liquid chromatograph Agilent 1200 with a fluorescent detector. Chromatographic determination of amino acids was performed on a liquid chromatograph Agilent 1200 (USA) with a fluorescent detector G1315A (USA) and an autosampler 1313A. Using the HPLC method, 16 amino acids were identified (essential – 6; conditionally – 2; nonessential – 8). Identified amino acids are almost in a bound state (1.5%), the largest amount is glutamic acid (0.23%), glycine (0.19%), aspartic acid (0.18%), proline (0.17%) and arginine (0.17%). In unbound form, the content of glutamic acid (0.09%) and glycine (0.06%) is the highest. Based on the results of research, you can choose quality indicators, to determine the appropriate criteria that can be proposed for the standardization of water extract from the crushed substrate of the xenoderm.

scholarly journals A comparative study on different market samples and standard samples of Shalaparni through physicochemical methods and near infrared spectroscopy

2014 ◽  
Vol 2 (04) ◽  
pp. 20-25
Author(s):  
Parth Raval ◽  
B. R. Patel ◽  
V. J. Shukla ◽  
Bhavesh Patil ◽  
Nehaparmar . ◽  
...  
Keyword(s):  
Infrared Spectroscopy ◽  
Comparative Study ◽  
Near Infrared Spectroscopy ◽  
Near Infrared ◽  
Poor Quality ◽  
Physicochemical Parameter ◽  
Standard Samples ◽  
Standard Drug ◽  
Physicochemical Methods ◽  
Potent Drug

Dashmoolais one of the most important groups explained in Mishrakagana. One of which, Shalaparni is a potent drug used single as well as in various formulations mentioned in classics. Adulteration in Dashmoolaplants is a very big issue now days and this is because of the lack of availability of the original drugs. In this study market samples of Shalaparni (Desmodium gangeticum DC.) collected from the different part of India; compared with the standard Shalaparni authenticated sample which was collected from the natural source; by using physicochemical parameter and near infrared spectroscopy. Results were statistically processed by PCA. The results show that there is no similarity found outbetween the standard drug and market samples of Shalaparni which were collected from different regions of India. The market samples were observed for different adulterated material having poor quality.

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