scholarly journals Quality and Authenticity of Metformin Tablets Circulating on Japanese Websites

2021 ◽  
Author(s):  
Shu Zhu ◽  
Naoko Yoshida ◽  
Hirohito Tsuboi ◽  
Ryo Matsushita ◽  
Kazuko Kimura
Keyword(s):  
Extended Release ◽  
The Internet ◽  
Content Uniformity ◽  
Substandard Medicines ◽  
Dissolution Tests ◽  
Two Samples ◽  
Sustained Release Tablets ◽  
Quality Testing ◽  
Falsified Medicines ◽  
States Pharmacopeia

Abstract Background Low-quality medicines and falsified medicines represent long-standing problems in developing countries. In Southeast Asia, the circulation of low-quality diabetes drugs (metformin) has been confirmed. It is possible that low-quality metformin has entered Japan via personal import through the Internet. This study evaluated the pharmaceutical quality and authenticity of metformin tablets obtained via the Internet in Japan. Methods In total, 33 samples of 500-mg metformin tablets and 7 samples of extended-release/sustained-release tablets (500, 750, and 1,000 mg) were purchased via personal import in January 2017. Confirmation of a prescription was never requested purchase. The obtained samples were subjected to visual observations and authenticity investigations. Additionally, quantitative analysis, content uniformity and dissolution tests were performed using HPLC–PDA. Results Our authenticity investigations revealed that seven samples were genuine products, whereas the authenticity of the remaining 33 samples was unclear. Referring to United States Pharmacopeia 2014 for validation, four samples failed quality testing, five samples failed content uniformity testing, and two samples failed dissolution testing. Conclusions Our findings illustrate that metformin tablets of poor-quantity and unregistered/unlicensed doses are available online and that it is important to increase consumer awareness about the presence of these medicines on the Internet to prevent the purchase of substandard medicines.

scholarly journals An Investigation into the Quality of Medicines in Yangon, Myanmar

Pharmacy ◽  
2018 ◽  
Vol 6 (3) ◽  
pp. 96 ◽  
Author(s):  
Md. Islam ◽  
Naoko Yoshida ◽  
Kazuko Kimura ◽  
Chisana Uwatoko ◽  
Mohammad Rahman ◽  
...  
Keyword(s):  
Poor Quality ◽  
Cefuroxime Axetil ◽  
Quality Analysis ◽  
Content Uniformity ◽  
Counterfeit Medicines ◽  
Ceftriaxone Sodium ◽  
Substandard Medicines ◽  
Dissolution Tests ◽  
Microbial Assay

Many poor-quality medicines are supplied to patients mainly in developing countries. No systematic survey on counterfeit medicines has been conducted in Myanmar since 1999. The purpose of this study was to investigate the current situation of substandard or counterfeit medicines in Myanmar. Samples of oral medicines, cefuroxime axetil (CXM), donepezil hydrochloride (DN) and omeprazole (OM), and injections, ceftriaxone sodium (CTRX), and gentamicin sulfate (GM), were collected from pharmacies, hospitals, and wholesalers in Yangon, Myanmar in 2014. Authenticity and quality were verified. There were 221 (94%) foreign medicines among 235 collected samples. Five samples of GM and 1 DN sample were not registered with the Food and Drug Administration, Myanmar. In quality analysis, 36 samples out of 177 (20.3%) did not pass quantity tests, 27 samples out of 176 (15.3%) did not pass content uniformity tests, and 23 out of 128 samples (18.0%) did not pass dissolution tests. Three of the unregistered GM samples failed in both identification and microbial assay tests. Counterfeit GM is being sold in Yangon. Also, the quality of OM is a matter of concern. Poor-quality medicines were frequently found among the products of a few manufacturers. Regular surveys to monitor counterfeit and substandard medicines in Myanmar are recommended.

scholarly journals Substandard and Falsified Medicines in Myanmar

Pharmacy ◽  
2020 ◽  
Vol 8 (1) ◽  
pp. 45
Author(s):  
Mirai Sakuda ◽  
Naoko Yoshida ◽  
Takashi Takaoka ◽  
Tomoko Sanada ◽  
Mohammad Sofiqur Rahman ◽  
...  
Keyword(s):  
World Health ◽  
Dissolution Test ◽  
Regulatory Guidance ◽  
Substandard Medicines ◽  
The World ◽  
Quality Testing ◽  
Falsified Medicines ◽  
Health Organization ◽  
The Relationship ◽  
Made In

Background: substandard and falsified medicines (SFMs) are a threat to public health. The availability of SFMs in Myanmar was reported by the World Health Organization (WHO) in 1999, but there have been few systematic surveys on falsified medicines in Myanmar since then. The aim of this study is to examine the extent of SFMs for sale in Myanmar. Methods: target medicines were tablets of candesartan, metformin, and pioglitazone, and infusions of ciprofloxacin and levofloxacin. Samples were collected from hospitals, pharmacies, and wholesalers located in the Mandalay region in 2015. We carried out observation testing, authenticity investigation, and quality testing to search for SFMs, and analyzed the relationship between SFMs and the price and store type. Results: There were no falsified medicines found in the authenticity check, though there remained a problem due to low response rates from manufacturers and regulatory authorities. In the quality test, some tablets of metformin and pioglitazone made in India failed the dissolution test. Conclusions: although no serious problems were found, some substandard medicines were detected. Regular surveys to monitor SFMs are therefore recommended, together with further regulatory guidance to improve conditions in all medicine manufacturers, distributors, and pharmacies.

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 Development and Bio-Predictive Evaluation of Biopharmaceutical Properties of Sustained-Release Tablets with a Novel GPR40 Agonist for a First-in-Human Clinical Trial

Pharmaceutics ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 804
Author(s):  
Ewelina Juszczyk ◽  
Kamil Kisło ◽  
Paweł Żero ◽  
Ewa Tratkiewicz ◽  
Maciej Wieczorek ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sustained Release ◽  
Development Strategy ◽  
Matrix Tablets ◽  
Matrix Tablet ◽  
Mechanical Agitation ◽  
Development Cycle ◽  
Dissolution Tests ◽  
Sustained Release Tablets ◽  
Biopharmaceutical Properties

Sustained-release (SR) formulations may appear advantageous in first-in-human (FIH) study of innovative medicines. The newly developed SR matrix tablets require prolonged maintenance of API concentration in plasma and should be reliably assessed for the risk of uncontrolled release of the drug. In the present study, we describe the development of a robust SR matrix tablet with a novel G-protein-coupled receptor 40 (GPR40) agonist for first-in-human studies and introduce a general workflow for the successful development of SR formulations for innovative APIs. The hydrophilic matrix tablets containing the labeled API dose of 5, 30, or 120 mg were evaluated with several methods: standard USP II dissolution, bio-predictive dissolution tests, and the texture and matrix formation analysis. The standard dissolution tests allowed preselection of the prototypes with the targeted dissolution rate, while the subsequent studies in physiologically relevant conditions revealed unwanted and potentially harmful effects, such as dose dumping under an increased mechanical agitation. The developed formulations were exceptionally robust toward the mechanical and physicochemical conditions of the bio-predictive tests and assured a comparable drug delivery rate regardless of the prandial state and dose labeled. In conclusion, the introduced development strategy, when implemented into the development cycle of SR formulations with innovative APIs, may allow not only to reduce the risk of formulation-related failure of phase I clinical trial but also effectively and timely provide safe and reliable medicines for patients in the trial and their further therapy.

Marketing Fruit and Vegetable Intake with Interactive Games on the Internet

2009 ◽  
Vol 15 (1_suppl) ◽  
pp. 136-154 ◽  
Author(s):  
Mary K. Buller ◽  
Ilima L. Kane ◽  
Andrea L. Dunn ◽  
Erika J. Edwards ◽  
David B. Buller ◽  
...  
Keyword(s):  
Social Marketing ◽  
Fruits And Vegetables ◽  
Vegetable Intake ◽  
Self Report ◽  
The Internet ◽  
Campaign Strategies ◽  
Interactive Games ◽  
Internet Users ◽  
Two Samples ◽  
Social Marketing Campaigns

National social marketing campaigns encourage Americans to eat at least five servings of fruits and vegetables each day to promote health and reduce chronic disease. Despite widespread promotion, consumption remains below recommended levels. The Internet and interactive games may prove to be novel campaign strategies. In this project, three interactive nutrition games were developed for the Centers for Disease Control and Prevention's Fruits and Veggies—More Matters website with the aims of increasing users' self-efficacy and intake of fruits and vegetables by teaching skills and providing practice in selecting healthy fruits and vegetables. The games were evaluated with two samples of adult Internet users who were recruited online in a pretest–posttest controlled design. Outcomes were assessed with self-report measures. Use of the games increased users' confidence that they could eat three or more servings of fruits and vegetables daily, but had no direct impact on actual dietary intake of these food items. Users found the games to be informative and satisfying. Further, those who were more satisfied with the games reported eating more servings of fruits and vegetables. Interactive games may stimulate use of social marketing websites and attract important hard-to-reach populations.

Comparison of Simvastatin Tablets from the US and International Markets Obtained via the Internet

2008 ◽  
Vol 42 (5) ◽  
pp. 613-620 ◽  
Author(s):  
Michael A Veronin ◽  
Nga T Nguyen
Keyword(s):  
Prescription Drugs ◽  
Web Sites ◽  
High Performance ◽  
International Markets ◽  
The Internet ◽  
Content Uniformity ◽  
Innovator Product ◽  
Drug Products ◽  
Weight Variation ◽  
The Us

Background: Convenient access to prescription drugs produced outside the US has been facilitated by the Internet. Of greatest concern to clinicians and policy-makers is product quality and patient safety. The Food and Drug Administration has issued warnings to potential buyers that the safety of drugs purchased through the Internet cannot be guaranteed and may present consumers with a health risk from substandard products. Objective: To determine whether generic simvastatin tablets and capsules obtained via the Internet from international markets are equivalent to the US innovator product regarding major aspects of pharmaceutical quality. Methods: Twenty simvastatin tablets and capsules were obtained for pharmaceutical analysis: 19 generic samples from international Internet pharmacy Web sites and the US innovator product. Tablet samples were tested according to US Pbarmacopeial (USP) guidelines where applicable, using high-performance liquid chromatography, disintegration, dissolution, weight variation, hardness, and assessment of physical characteristics. These tests are often used to detect formulation defects of drug products during the manufacturing process. Results: Several international samples analyzed were not comparable to the US product in one or more aspects of quality assurance testing, and significant variability was found among foreign-made tablets themselves. Five samples failed to meet USP standards for dissolution and 2 for content uniformity. Among all samples, variability was observed in hardness, weight, and physical characterization. Conclusions: Results suggest that manufacturing standards for the international generic drug products compared with the US innovator product are not equivalent with regard to quality attributes. These findings have implications for safety and effectiveness that should be considered by clinicians to potentially safeguard patients who choose to purchase foreign-manufactured drugs via the Internet.

Medicine Quality: the harder you look the worse it gets

2016 ◽  
Vol 2 (11) ◽  
Author(s):  
Roger Bate
Keyword(s):  
Drug Resistance ◽  
Font Size ◽  
Patient Death ◽  
Substandard Medicines ◽  
Falsified Medicines ◽  
Medicine Quality ◽  
Excellent Method

<p><span style="font-family: Calibri; font-size: medium;">The Minilab protocol is an excellent method of identifying falsified medicines, and two per cent (18 out of 899 samples) were falsified. However, as the data in this paper show, it considerably underestimates (by roughly 4.5%) the amount of substandard medicines in the market (roughly 12 per cent), especially among medicines made by Indian companies. In addition to considerable patient death, substandard antimicrobial medicines are likely to drive drug resistance. Policymakers should redouble efforts to identify and combat such medicines.</span></p>

scholarly journals Automated Stopped-Flow Fluorimetric Sensor for Biologically Active Adamantane Derivatives Based on Zone Fluidics

Molecules ◽  
2019 ◽  
Vol 24 (21) ◽  
pp. 3975 ◽  
Author(s):  
Paraskevas D. Tzanavaras ◽  
Sofia Papadimitriou ◽  
Constantinos K. Zacharis
Keyword(s):  
Sampling Rate ◽  
Hplc Method ◽  
Biologically Active ◽  
The Internet ◽  
Adamantane Derivatives ◽  
Content Uniformity ◽  
Stopped Flow ◽  
Indole Derivatives ◽  
Flow Conditions

A zone-fluidics (ZF) based automated fluorimetric sensor for the determination of pharmaceutically active adamantine derivatives, i.e., amantadine (AMA), memantine (MEM) and rimantadine (RIM) is reported. Discrete zones of the analytes and reagents (o-phthalaldehyde and N-acetylcysteine) mix and react under stopped-flow conditions to yield fluorescent iso-indole derivatives (λex/ λem = 340/455 nm). The proposed ZF sensor was developed and validated to prove suitable for quality control tests (assay and content uniformity) of commercially available formulations purchased from the Greek market (EU licensed) and from non-EU web-pharmacies at a sampling rate of 16 h−1. Interestingly, a formulation obtained through the internet and produced in a third—non-EU—country (AMA capsules, 100 mg per cap), was found to be out of specifications (mean assay of 85.3%); a validated HPLC method was also applied for confirmatory purposes.

Weight Variability of Scored and Unscored Psychotropic Drug Tablets Split by a Uniquely Designed Tablet Splitting Device

2005 ◽  
Vol 40 (4) ◽  
pp. 321-325 ◽  
Author(s):  
Robert J. Nolly ◽  
Patrick Rodrigues ◽  
Laura Thoma
Keyword(s):  
United States ◽  
Standard Deviation ◽  
The United States ◽  
United States Pharmacopeia ◽  
Content Uniformity ◽  
Weight Variation ◽  
Tablet Splitting ◽  
Relative Standard ◽  
Balance Weight ◽  
States Pharmacopeia

Tablets of three psychotropic drugs were split using a uniquely designed tablet splitting device, the Tru-Cut Multi-Tablet Cutter, and evaluated for weight variation utilizing criteria based on the United States Pharmacopeia (USP) <27> Uniformity of Dosage Units Content Uniformity Criteria. Whole tablets of Risperdal 2 mg and 4 mg, Paxil 20 mg and 40 mg, and Zoloft 100 mg were split by a device that positioned tablets in tablet specific disposable trays for splitting. Each half tablet weight was recorded utilizing a digital electronic balance. Weight variability was determined by comparing actual half tablet weight to theoretical half tablet weight and calculation of the relative standard deviation. Results showed half tablets of all drugs met the weight variation criteria resulting in uniform half tablet dosages as defined by the criteria.

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