Comparison of Three Pharmaceutical Products Obtained from Mexico and the United States: A Case Study

ABSTRACT

In recent years, there has been much debate concerning the relative pros and cons of purchasing medications from foreign markets such as Mexico and Canada. The following study compares the content uniformity and weight variation for three medicinal products, acquired from pharmacies in both Mexico and the United States: amoxicillin capsules (500 mg), amoxicillin/clavulanic acid suspension (400 mg and 57 mg/5 mL, respectively), and furosemide tablets (40 mg). Twenty capsules/tablets were individually weighed and a designated aliquot was taken. Following dissolution in an appropriate solvent and sonication, a sample was taken and analyzed via high performance liquid chromatography (HPLC). The suspensions were prepared according to directions on the label. Five samples of the suspensions were then taken and analyzed via an appropriate HPLC method. The content uniformity for the amoxicillin capsules was found to be 15.4 ± 2.4% and 99.4 ± 9.3%, for Mexican and U.S. capsules, respectively. The percent relative standard deviation (% RSD) for weight variation was found to be 8.7% and 1.5% for capsules obtained from Mexico and the United States, respectively. Content uniformity analysis for the Mexican suspension product resulted in an average of 85.5 ± 1.2% for amoxicillin and 98.6 ± 1.9% for the clavulanic acid content, while the results for the U.S. suspension product were 104.4 ± 3.1% and 117.8 ± 3.6% for amoxicillin and clavulanic acid, respectively. Content uniformity for the furosemide tablets was found to be 90.3 ± 4.8% and 95.6 ± 2.1% for Mexican and U.S. tablets, respectively. The % RSD of weight variation for the Mexican tablets was 2.1%, while the % RSD for the U.S. tablets was found to be 1.0%. From the three products tested, content analysis revealed that the amount of active ingredients for two of the products acquired in Mexico were appreciably less than the concentrations for their U.S. counterparts.     

Institutional self-citation rates: A three year study of universities in the United States

Using Institute for Scientific Information (ISI) data, this paper calculated institutional self citations rates (ISCRs) for 96 of the top research universities in the United States from 2005–2007. Exhibiting similar temporal patterns of author and journal self-citations, the ISCR was 29% in the first year post-publication, and decreased significantly in the second year post-publication (19%). Modeling the data via power laws revealed total publications and citations did not correlate with the ISCR, but did correlate highly with ISCs. California Institute of Technology exhibited the highest ISCR at 31%. Academic and cultural factors are discussed in relation to ISCRs.     

Regional economic integration and foreign direct investment: The case of NAFTA

Abstract and Key Results

Environmental impact of military base closure in the United States: a case study on the closing of Fort Sheridan,Illinois

In 1991, the Fort Sheridan Army Garrison was slated for closure and remediation. This would have a significant economic and environmental impact on the region, particularly the three surrounding communities. Once the base closed, there would be about 700 acres of what are considered some of Illinois' most valuable real estate available for future use. This study identified the hazards, such as soil and groundwater contaminated with toxic or hazardous fuels, that were found as a result of the military activity; it analyzes the process by which the conflicting regulatory authorities assessed the facility. Particular emphasis focuses on how the Army communicated the risks found at the base to the three surrounding communities.     

The influence of direct compression powder blend transfer method from the container to the tablet press on product critical quality attributes: a case study

Objective: The aim of this article is to compare the gravitational powder blend loading method to the tablet press and manual loading in terms of their influence on tablets’ critical quality attributes (CQA).

Significance: The results of the study can be of practical relevance to the pharmaceutical industry in the area of direct compression of low-dose formulations, which could be prone to content uniformity (CU) issues.

Methods: In the preliminary study, particle size distribution (PSD) and surface energy of raw materials were determined using laser diffraction method and inverse gas chromatography, respectively. For trials purpose, a formulation containing two pharmaceutical ingredients (APIs) was used. Tablet samples were collected during the compression progress to analyze their CQAs, namely assay and CU.

Results: Results obtained during trials indicate that tested direct compression powder blend is sensitive to applied powder handling method. Mild increase in both APIs content was observed during manual scooping. Gravitational approach (based on discharge into the drum) resulted in a decrease in CU, which is connected to a more pronounced assay increase at the end of tableting than in the case of manual loading.

Conclusions: The correct design of blend transfer over single unit processes is an important issue and should be investigated during the development phase since it may influence the final product CQAs. The manual scooping method, although simplistic, can be a temporary solution to improve the results of API’s content and uniformity when compared to industrial gravitational transfer.     

Solar assisted cooling with sorption systems: status of the research in Mexico and Latin America

Solar refrigeration projects both national and international with sorption and other refrigeration systems have been developed in Mexico and other Latin American countries in the last 15 years. A review of the main projects, both for solar cooling and refrigeration and the results obtained are presented in this paper. A methodology where 19 solar technologies for cooling were identified is also presented. Although solar cooling is still not an economically viable technology, the advances made and the experience gained in the projects described and the improved systems envisaged, will make solar refrigeration systems play an important role in the future.     

中美致密砂岩气成藏分布异同点比较研究与意义

致密砂岩气已成为全球非常规天然气勘探的重点领域。中国致密砂岩气分布范围广,目前已在鄂尔多斯、四川等盆地实现了规模开发;美国落基山地区是致密砂岩气十分发育和勘探相对成熟的地区。对比研究中美致密砂岩气的形成条件和成藏特征是加快中国致密气开发利用与开拓勘探思路的有效途径。中国与美国致密气藏对比研究表明,中美致密砂岩气具有以煤系地层为主要烃源岩、储层致密、存在异常地层压力、源储紧邻与气藏大面积分布等共性特征;差异性主要体现在致密气源岩沉积环境与热演化程度,储层非均质性及其致密化因素,气藏纵向和平面分布特征等方面;控制中美致密砂岩气成藏条件和特征差异性的主要因素是沉积盆地性质、沉积环境和后期构造作用。针对中国致密砂岩气的特殊性,加强储层非均质性、优质储层预测、气藏的分布规律的研究以及加强工程技术攻关提高单井累计产量是致密砂岩气勘探开发工作的重点。     

Soil-borne polycyclic aromatic hydrocarbons in El Paso, Texas: analysis of a potential problem in the United States/Mexico border region

Ultrasonic extraction followed by Stir Bar Sorptive Extraction (SBSE) and thermal desorption inline coupled with Gas Chromatography and Mass Spectrometry (TD/GC/MS) was used to perform a comprehensive determination of soil-borne polycyclic aromatic hydrocarbons (PAHs) in El Paso, Texas. The method provided good sensitivity and faster processing time for the analysis. The total PAHs in El Paso soil ranged from 0.1 to 2225.5 microg kg(-1). Although the majority of PAH concentrations did not exceed the soil screening levels regulated by the United States Environmental Protection Agency, the existence of PAHs in this ecosystem is ubiquitous. Naphthalene were found in 100% of the soil samples; while the heavy PAHs (five- and six-ring) were not often detected and mostly remained in closer proximity to industrial areas and major traffic points. The results ruled out the possibility of petroleum refining as the significant source of local soil-borne PAH contamination, but they suggested that the PAHs found in El Paso soil were closely linked to human activities and possible other industrial processes.     

Environmental impact of warehousing: a scenario analysis for the United States

In recent years, there has been observed a continued growth of global carbon dioxide emissions, which are considered as a crucial factor for the greenhouse effect and associated with substantial environmental damages. Amongst others, logistic activities in global supply chains have become a major cause of industrial emissions and the progressing environmental pollution. Although a significant amount of logistic-related carbon dioxide emissions is caused by storage and material handling processes in warehouses, prior research mostly focused on the transport elements. The environmental impact of warehousing has received only little attention by research so far. Operating large and highly technological warehouses, however, causes a significant amount of energy consumption due to lighting, heating, cooling and air condition as well as fixed and mobile material handling equipment which induces considerable carbon dioxide emissions. The aim of this paper is to summarise preliminary studies of warehouse-related emissions and to discuss an integrated classification scheme enabling researchers and practitioners to systematically assess the carbon footprint of warehouse operations. Based on the systematic assessment approach containing emissions determinants and aggregates, overall warehouse emissions as well as several strategies for reducing the carbon footprint will be studied at the country level using empirical data of the United States. In addition, a factorial analysis of the warehouse-related carbon dioxide emissions in the United States enables the estimation of future developments and facilitates valuable insights for identifying effective mitigation strategies.     

The use of the United States FDA programs as a strategy to advance the development of drug products for neglected tropical diseases

Neglected tropical diseases (NTDs) are infections which are endemic in poor populations in lower- and middle-income countries (LMIC). Approximately one billion people have now or are at risk of getting an NTD and yet less than 5% of research dollars are focused on providing treatments and prevention of these highly debilitating and deadly conditions. The United States Food and Drug Administration (FDA) Orphan Drug Designation program (ODDP) provides orphan status to drugs and biologics, defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases and/or disorders that affect fewer than 200 000 people in the United States, or that affect more than 200 000 persons but are not expected to recover the costs of developing and marketing a treatment drug. These regulations have led to the translation of rare disease knowledge into innovative rare disease therapies. The FDA Guidance for Industry on developing drugs for the treatment and prevention of NTDs describes the following regulatory strategies: Orphan Product Designation, Fast Track Designation, Priority Review Designation, Accelerated Approval and Tropical Disease Priority Review Voucher. This paper will discuss how these regulations and especially the ODDP can improve the clinical development and accessibility of drug products for NTDs.     

Power of experimental design studies for the validation of pharmaceutical processes: case study of a multilayer tablet manufacturing process

Experimental design studies (EDS) are already widely used in the pharmaceutical industry for drug formulation or process optimization. Rare are the situations in which this methodology is applied for validation purposes. The power of this statistical tool, key element of a global validation strategy, is demonstrated for a multilayer tablet manufacturing process. Applied to the Geomatrix® system generally composed of one compression and three granulation processes, time and strictness gains are non-negligible. Experimental design studies are not used in this work for modeling. Introduced at each important step of the process development, they allow for the evaluation of process ruggedness at pilot scale and specifications for full production. A demonstration of the complete control of key process parameters is given, identified throughout preliminary studies.     

The face of the patent is not the “Whole Story”: determining effective life of a pharmaceutical patent in the United States

This article provides an overview of the factors that may contribute to the effective term of protection for a pharmaceutical product in the USA––by patent and by FDA market exclusivities, identifies public and commercial sources for collecting relevant patent term and exclusivity data, and provides a strategy for ensuring that the effective term of protection has been calculated accurately.     

Product category rules and environmental product declarations as tools to promote sustainable products: experiences from a case study of furniture production

New requirements and regulations have increased the pressure on companies to provide information on their products. This is challenging for small- and medium-sized enterprises (SMEs) since they lack both expertise and resources. In this paper, the possibilities to develop environmental product declarations (EPDs) for products with use of data-assistant tools are explored. A case study of furniture production in Norway is used to exemplify this. A database with specific environmental data for materials used in furniture has been developed. The database is used to conduct the life cycle assessment (LCA) for selected products and is the backbone of a data-assistance tool used to design and present the EPDs. Five key performance indicators are selected. The database and these KPIs ensures standardised assessments of products that enables both comparison of existing products as well as assessment of environmental performance of redesigned products and potential new products. This paper shows how this enables the SMEs to both provide environmental performance information to stakeholders as well as enables them to identify possible improvements with limited resources and competence on environmental performance and LCAs.     

Transfer of knowledge from the service phase: a case study from the oil industry

This paper aims to investigate the knowledge generated during the later phases of the life cycle of a complex customised product and understand how this knowledge is transferred between projects and between different user groups. A series of four identical rigs for offshore drilling was selected as a case study, and the transfer of knowledge between the first two rigs was explored through two sets of interviews with the rig operators and the project management team. The expected knowledge transfer strategies that emerged from the first set of interviews were analysed and compared with the actual transfer mechanisms identified in the second set of interviews, and similarities and differences were investigated. It was found that the transfer of knowledge primarily occurred within the individual phases of the product’s life cycle, and there was poor transfer across the different phases.     

Comparison between measurements and modeling of UV-B irradiance for clear sky: a case study

We compare the TJV-B global and direct irradiances computed with a radiative transfer model (discrete ordinate method) and measured during a European intercomparison campaign in Greece in July 1991, with clear sky. The agreement between the model and the measurements is within 6%. The sensitivity of the model to the accuracy of the input parameters as well as the potential of modeling for instrument calibration is discussed.     

跨文化视域下赴美留学生的文化适应性研究及设计思考

每年超过百万的国际学生就读于美国院校,这些学生中大多数根据既定的学习计划在一定的期限内获得学位。留学生赴美国读书一般都有明确的学术目标,但对社交生活的了解甚少。在这种情况下,大多数留学生会经历一个被称为"文化冲击"的普遍现象,它涉及生活及学习环境的适应困难,以及与当地学生和当地社区接触的局限性。虽然近年来教育工作者和研究人员一直在研究这个问题,并提出了补救建议,但如何提升跨文化学习的适应性很少在交互设计领域进行拓展。文章通过分析国际学生在北美校园融入过程中的障碍因素,以设计的视角提出优化建议,以在跨文化学习的背景下提升留学生的文化适应性为研究目的。     

Multiblock analysis of environmental measurements: A case study of using Proton Induced X-ray Emission and meteorology dataset obtained from Islamabad Pakistan

This paper reports the analysis of a multiblock environmental dataset consisting of 176 samples collected in Islamabad Pakistan between February 2006 and August 2007. The concentrations of 32 elements in each sample were measured using Proton Induced X-ray Emission plus black carbon for both coarse and fine particulate matter. Six meteorological parameters were also recorded, namely maximum and minimum daily temperatures, humidity, rainfall, windspeed and pressure. The data were explored using Principal Components Analysis (PCA), Partial Least Squares (PLS), Consensus PCA, Multiblock PLS, Mantel test, Procrustes analysis and the R_V coefficient. Seasonal trends can be identified and interpreted. Using the elemental composition of the particulates it is possible to predict meteorological parameters. Based on the models from PLS, it is possible to use elemental composition in the airborne particulates matter (APM) to predict meteorological parameters. The results from block similarity measures show that fine APM resembles meteorological parameters better than coarse APM. Multiblock PLS models however are not better than classical PLSR. This paper also demonstrates the potential of multiblock approach in environmental monitoring.     

Launch of a product and patents: evidence from the US cardiovascular pharmaceutical sector

ABSTRACT

Recent literature on the role of patents in shaping competition between incumbents and new entrants shows mixed evidence, as patents can discourage entry into markets but may also encourage potential entrants by increasing profitability from research and development. The increasing use of patents as strategic weapons motivates this investigation of the impact of innovation on competition. In a case study of US pharmaceutical cardiovascular submarkets over the period 1988–1998, we use a panel probit model to study the impact of a firm’s patents and rivals’ patents in the firm’s decision to launch new products. Our results show that the number of a firm’s lagged patents encourages the firm’s entry with new products, while rivals’ initial stock of patents discourages entry, but more recent patents promote entry by opening new technological opportunities.     

Reliability and economic analysis and improvement of complex mechanical products based on DEA: An empirical case study of hydraulic products

Complex mechanical products involve many specialized fields such as machinery, electronics, hydraulics, and computers, so their initial cost is usually higher. In addition, regular and irregular maintenance are also needed to extend their service life, so that the cost of the product in its life cycle will be increased. Therefore, for the manufacturing enterprises of complex mechanical products, it is very important to achieve the best matching between reliability and economy. In order to survive in the fierce market competition, it is necessary to compare with other similar products in the market, so as to clearly understand the level of their products, find out the gap, and improve it. However, the existing product reliability assessment methods based on probability and statistics theory cannot provide such help for them to solve this problem. Therefore, this paper puts forward a method to evaluate and improve complex mechanical products by using a data envelopment analysis (DEA) model considering the reliability and economy of product comprehensively. Through the relative effectiveness of DEA, the same type of products on the market can be compared, providing specific method for enterprises to evaluate and improve their own product level to achieve the best matching of economy and reliability. This paper introduces the principle and steps of this method and takes the hydraulic component manufacturing enterprise as an example to carry out practical research, which verifies the feasibility and effectiveness of this method.