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.

“Insight” into Drug Quality: Comparison of Simvastatin Tablets from the US and Canada Obtained via the Internet

2007 ◽  
Vol 41 (7-8) ◽  
pp. 1111-1115 ◽  
Author(s):  
Michael A Veronin ◽  
Eunah Lee ◽  
E Neil Lewis
Keyword(s):  
Near Infrared ◽  
Imaging Techniques ◽  
Active Pharmaceutical Ingredient ◽  
The Internet ◽  
Economic Implications ◽  
Innovator Product ◽  
Drug Products ◽  
Significant Difference ◽  
The Us ◽  
Blend Uniformity

Background: Recently, there has been much debate in the US concerning drug importation from Canadian Internet pharmacies. The Food and Drug Administration and US drug manufacturers assert that drugs obtained from international markets via the Internet present a health risk to consumers from substandard products. The public's perception is that drugs from Canada are as safe as those from the US. Objective: To determine whether simvastatin tablets obtained via the Internet from Canadian generic manufacturers are comparable in blend uniformity, a major attribute of tablet quality, with the US innovator product. Methods: Generic simvastatin tablets from 4 Canadian Internet pharmacy Web sites and the US innovator product were obtained for pharmaceutical analysis, Tablet samples were analyzed using near-infrared spectroscopic imaging techniques, which are designed to detect formulation defects of drug products during the manufacturing process. Digital images were created, revealing the tablets’ internal structures. Results: The blend uniformity of the active pharmaceutical ingredient in the tablet samples from Canada was determined and compared with that of the US innovator product. Results indicated that there is little significant difference in blend uniformity among US innovator and Canadian generic tablets. Conclusions: Results of this study suggest comparable quality assurance manufacturing standards for the US innovator product and the Canadian generic drug products tested. These findings have clinical, legal, and economic implications that should be addressed by policy makers to safeguard consumers who choose to purchase Canadian-manufactured drugs via the Internet.

scholarly journals COMPARATIVE STUDY OF SEVEN BRANDS OF LEVOFLOXACIN 500 MG FILM-COATED TABLET MARKETED IN YEMEN

2021 ◽  
pp. 264-268
Author(s):  
GAMIL Q. OTHMAN ◽  
YASER M. AL-WORAFI ◽  
MOHAMMED M. BATTAH ◽  
ABDULSALAM M. HALBOUP ◽  
HASSAN M. HASSAN
Keyword(s):  
Quality Control ◽  
High Performance ◽  
Hardness Test ◽  
The United States ◽  
Content Uniformity ◽  
Disintegration Time ◽  
Optimum Range ◽  
Weight Variation ◽  
Coated Tablet

Objective: The objective of the current study was to evaluate the quality control parameters of seven brands of levofloxacin 500 mg film-coated tablet available in the Yemeni market. Methods: Physicochemical parameters assay was performed for seven brands of levofloxacin 500 mg film-coated tablet. Each brand was subjected to official and unofficial in vitro quality control tests, including weight variation, thickness, hardness, friability, disintegration, dissolution, and content uniformity assay by High-Performance Liquid Chromatography (HPLC). Results: Out of seven, six brands of levofloxacin 500 mg film-coated tablet passed official specified assay tests according to the United States Pharmacopeia (USP) specifications. They showed a similar profile of thickness ranged between±0.01 and 0.10%, friability ranged between 0.01% and 0.34%, disintegration time ranged between 3.00 and 15.00 min, dissolution percentage ranged between 90.650 and 103.05 and content uniformity ranged between 93.62 and 107.12%. Regarding weight variation and hardness, six brands passed the weight variation test and only three brands showed optimum range (10-20 kg) of hardness test. Only one brand failed to pass the weight variation test, and four brands failed to pass the optimum range (10-20 kg) of hardness. Conclusion: There are no remarkable differences between the seven brands regarding in vitro quality control tests of content uniformity, thickness, friability, disintegration, and dissolution. Even though four brands were above the optimum range of hardiness, they showed complete disintegration and dissolution within the acceptable limit. Regular assessment of marketed drugs is required to ensure bioequivalent to their innovators.

scholarly journals Drug Content Uniformity: Quantifying Loratadine in Tablets Using a Created Raman Excipient Spectrum

Pharmaceutics ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 309
Author(s):  
Amelia Farquharson ◽  
Zachery Gladding ◽  
Gary Ritchie ◽  
Chetan Shende ◽  
Joseph Cosgrove ◽  
...  
Keyword(s):  
Raman Spectrum ◽  
Raman Spectra ◽  
High Performance ◽  
Drug Product ◽  
Active Pharmaceutical Ingredient ◽  
Relative Mass ◽  
Content Uniformity ◽  
Counterfeit Drugs ◽  
Simple Method ◽  
The Us

Raman spectroscopy has proven valuable for determining the composition of manufactured drug products, as well as identifying counterfeit drugs. Here we present a simple method to determine the active pharmaceutical ingredient (API) mass percent in a sample that does not require knowledge of the identities or relative mass percents of the inactive pharmaceutical ingredients (excipients). And further, we demonstrated the ability of the method to pass or fail a manufactured drug product batch based on a calculated acceptance value in accordance with the US Pharmacopeia method for content uniformity. The method was developed by fitting the Raman spectra of 30 Claritin® tablets with weighted percentages of the Raman spectrum of its API, loratadine, and a composite spectrum of the known excipients. The mean loratadine mass of 9.79 ± 40 mg per 100 mg tablet compared favorably to the 10.21 ± 0.63 mg per 100 mg tablet determined using high-performance liquid chromatography, both of which met the acceptance value to pass the 10 mg API product as labelled. The method was then applied to a generic version of the Claritin product that employed different excipients of unknown mass percents. A Raman spectrum representative of all excipients was created by subtracting the API Raman spectrum from the product spectrum. The Raman spectra of the 30 generic tablets were then fit with weighted percents of the pure loratadine spectrum and the created excipient spectrum, and used to determine a mean API mass for the tablets of 10.12 ± 40 mg, again meeting the acceptance value for the 10 mg API product. The data suggest that this simple method could be used to pass or fail manufactured drug product batches in accordance with the US Pharmacopeia method for content uniformity, without knowledge of the excipients.

scholarly journals Post-marketing Assessment of Esomeprazole and Lansoprazole Enteric Coated Products Available in Saudi Arabia Based on Quality Control

2021 ◽  
pp. 94-106
Author(s):  
Doaa Hasan Alshora ◽  
Mohamed Abbas Ibrahim ◽  
Ahmed Mohammed Alomar ◽  
Tahani Nasser Alsufian
Keyword(s):  
Quality Control ◽  
In Vitro Dissolution ◽  
Content Uniformity ◽  
Drug Products ◽  
Relative Standard ◽  
The Us ◽  
Post Marketing ◽  
Generic Products ◽  
Enteric Coated

Introduction: Esomeprazole (ESM) and Lansoprazole (LNZ) are proton pump inhibitors, used in the treatment of peptic ulcer and gastroesophageal reflux disease. Different marketed generic products for both drugs are now available in Saudi market as enteric coated dosage form. Different factors can affect the drug release from enteric coated formulation, and therefore, the final product should be tested. Methodology: In this study three different ESM generic products (20 and 40 mg) and four LNZ generic products (15 and 30 mg) were assessed and compared to the innovator products based on quality control tests. Results: For ESM, it was found that the content uniformity results for the innovator product (Nexium®) and all other generic products lies between 85-115% with relative standard deviation (RSD) less than 6%. Also, the calculated Acceptance values (AV) was less than 15% (L1), which met the US Pharmacopeia. The in-vitro dissolution test in acid stage for Nexium® and other ESM generic products was less than 10% which met the requirement. In case of LNZ, 4 different generic enteric coated pellets filled in capsules were studied and compared to its innovator (Lanzor®), the content uniformity results showed that all products met the requirement with AV less than 15%. The in-vitro dissolution studies showed that all products met the requirement and release less than 10% of the drug in the acidic media, except LNZ-P2 containing both 15 and 30 g LNZ, which exhibited release more than 10% in the acids stage. Conclusion: post-marketing assessments for drug products play an important rule to figure out the non-effective products.

scholarly journals Manteniendo lazos vía Web: El Caso de las Comunidades Mexicanas de Emigrantes en los EUA

2007 ◽  
Vol 3 (3) ◽  
Author(s):  
Victor M Gonzalez ◽  
Luis A Castro-Quiroa
Keyword(s):  
Web Sites ◽  
Family Members ◽  
Physical Distance ◽  
The Internet ◽  
Leaving Home ◽  
The Past ◽  
The Us ◽  
The World ◽  
The Usa ◽  
Diasporic Communities

Migration has gained considerable attention in the past few years all over the world. The migratory phenomenon has already affected many countries and is likely to deeply reshape forever their societies and regulations. Of particular interest is the migratory flow from Mexico to the USA, which is identified as one of the most important labor related worldwide. It has been found that migration can potentially have a major impact on individuals leaving home as they can experience nostalgic feelings. As a result of physical distance, family members look for closeness to prevail by maintaining in permanent communication. This paper offers an analysis of web sites from Mexican diasporic communities living in the US, aiming to reveal the level of presence of those communities on the Internet as well as to characterize the support they provide for living-away members of the communities.

Managing Web Site Performance and Reliability

2001 ◽  
pp. 187-202
Author(s):  
Ross A. Lunley
Keyword(s):  
Web Sites ◽  
Web Site ◽  
High Performance ◽  
The Internet ◽  
Goods And Services ◽  
Shopping Experience ◽  
Market Leader

An organization’s e-commerce strategies either represent their entire existence for an Internet-only business or a significant investment by a traditional business. Competition on the Internet has resulted in many sites where a shopper can find the same goods and services. The differentiator for the market leader in a particular e-business is a positive shopping experience for the customer, which includes providing a reliable and high-performance Web site. This chapter describes a number of approaches to building reliable and high-performance Web sites.

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