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Pharmaceutical Products (pharmaceutical + products)
Selected AbstractsContext and Ambiguity in the Making of Law: A Comment on Amending India's Patent ActTHE JOURNAL OF WORLD INTELLECTUAL PROPERTY, Issue 5 2007Dwijen Rangnekar In implementing its patent-related obligations to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), India opted for the optional additional transitional provisions in article 65.4. This, delayed the introduction of product patents in exempt technologies, notably pharmaceuticals, until 1 January 2005. Ostensibly, this gave India the opportunity to exploit changing circumstances to and emergent views on TRIPS implementation, in particular exploring new interpretations to residual flexibility in TRIPS and any continuing legal ambiguity in TRIPS obligations. Here, the Panel Report in Canada: Patent Protection of Pharmaceutical Products is pertinent in having exhibited rare reticence in stepping back from defining the principle of non-discrimination in article 27.1 of TRIPS. In maintaining legal ambiguity, this reticence also provides space for law-making and regulatory diversity. The article reviews the three amendments to India's Patent Act 1970 and finds mixed use of residual flexibility and some evidence of efforts to explore legal ambiguity. Thus, despite a favourable climate to TRIPS implementation and an active transnational access to medicine campaign, legislators in India have demonstrated a degree of caution. The article concludes that this caution is best explained in terms of deepening ambivalence concerning intellectual property within the government and the changing economic interests of sections of Indian pharma. [source] Determination of molar mass and solution properties of cationic hydroxyethyl cellulose derivatives by multi-angle laser light scattering with simultaneous refractive index detectionPOLYMER INTERNATIONAL, Issue 10 2009Wei Gao Abstract BACKGROUND: A complete understanding of the molar mass and solution properties of raw materials in bio/pharmaceutical products under bio-application and natural conditions ensures process control, product performance and quality. Biopolymers including polymeric cationic hydroxyethyl cellulose derivatives (e.g. Polyquaterium-10 or Polymer JR) have long been used in health care formulations including shampoos, lotions, eye drops and contact lens multi-purpose solutions. Previously reported molar masses and conformation of Polymer JR were based on size exclusion chromatography-related techniques, which required highly concentrated buffered salt solutions and organic solvent modifiers to prevent undesirable interactions, and did not represent the isotonic conditions in products and applications. RESULTS: This paper describes the characterization of Polymer JR in saline using a new approach that combines micro-batch mode multi-angle laser light scattering with simultaneous refractive index measurements (MB-MALLS-RI). Mass-average molar mass, z -average radius of gyration and second virial coefficient values in phosphate buffer saline (PBS) were obtained and are discussed in detail. CONCLUSION: The molar mass and solution properties of Polymer JR in PBS, with the same pH and ionic strength as most health care solution products, can be characterized using the MB-MALLS-RI technique. The approach is practical and can be widely used for the analysis of other cationic biopolymers. Copyright © 2009 Society of Chemical Industry [source] Limited LCAs of pharmaceutical products: merits and limitations of an environmental management toolCORPORATE SOCIAL RESPONSIBILITY AND ENVIRONMENTAL MANAGEMENT, Issue 2 2003Anne Marie de Jonge This article explores both the merits and the limitations of life cycle analysis (LCA) as an environmental management tool in the framework of the pharmaceutical industry. In this study, limited LCAs in the form of product lifecycle-oriented energy balances were established for two rather different pharmaceutical products. Primary energy requirements served as the single indicator for the products' direct and indirect environmental impacts. The functional units of the products were defined as the one year treatments of average patients. The results of the case studies indicate that the portion of the active substance in the pharmaceutical end product is an important predictor for the breakdown of energy requirements and thus environmental impacts over the life cycle. Despite its limitations, the energy balances provide first-hand indications of where eco-efficiency measures should be taken. In this sense, the limited LCAs served as a useful environmental management tool. Copyright © 2003 John Wiley & Sons, Ltd. and ERP Environment [source] Parallel trade, price discrimination, investment and price capsECONOMIC POLICY, Issue 44 2005Stefan Szymanski SUMMARY Parallel trade Parallel trade is the resale of a product by a wholesaler in a market other than that intended by the manufacturer. One of its consequences is that manufacturers may be prevented from price discriminating between markets that have different willingness to pay for the product in question. Some legal regimes give the manufacturer the right to prohibit parallel trade, but others do not. We examine the policy implications of parallel trade in a world in which manufacturers invest in product quality, and have the possibility to develop different quality variants of their goods. We also consider the possibility that the authorities may impose price caps and compulsory licensing (as commonly occurs for some pharmaceutical products). We find that taking investment incentives into account makes parallel trade much less likely to enhance overall welfare, which implies that parallel trade in products intensive in R&D, such as pharmaceuticals, is less desirable than in fields such as branded consumer products. We also find that, somewhat surprisingly, the threat of parallel trade does not induce firms to market inferior versions of their products in poor countries. However, parallel trade is less likely to be detrimental to welfare when there are price caps, since compulsory licensing can mitigate the major cost of parallel trade (namely a refusal to supply a poor country market). , Stefan Szymanski and Tommaso Valletti [source] Re-inscribing Gender in New Modes of Medical Expertise: The Investigator,Coordinator Relationship in the Clinical Trials IndustryGENDER, WORK & ORGANISATION, Issue 2 2010Jill A. Fisher This article analyses the ways in which research coordinators forge professional identities in the highly gendered organizational context of the clinic. Drawing upon qualitative research on the organization of the clinical trials industry (that is, the private sector, for profit auxiliary companies that support pharmaceutical drug studies), this article explores the relationships between predominantly male physician-investigators and female research coordinators and the constitution of medical expertise in pharmaceutical drug development. One finding is that coordinators actively seek to establish relationships with investigators that mirror traditional doctor,nurse relationships, in which the feminized role is subordinated and devalued. Another finding is that the coordinators do, in fact, have profound research expertise that is frequently greater than that of the investigators. The coordinators develop expertise on pharmaceutical products and diseases through their observations of the patterns that occur in patient,participants' responses to investigational drugs. The article argues, however, that the nature of the relationships between coordinators and investigators renders invisible the coordinators' expertise. In this context, gender acts as a persistent social structure shaping both coordinators' and investigators' perceptions of who can be recognized as having authority and power in the workplace. [source] A very promising new glucolipidic surfactant: LipowheatTMINTERNATIONAL JOURNAL OF COSMETIC SCIENCE, Issue 6 2005A. Djedour Synopsis LipowheatTM is an entirely biodegradable 100% natural active ingredient, extracted from non-transgenic wheat. Thanks to its very interesting properties, it can integrate the composition of most cosmetic and pharmaceutical products. The aim of this work was first to realize a large range of stable simple or multiple emulsions, in order to determine and evaluate the ability of a new glucolipidic surfactant LipowheatTM to form and stabilize emulsions. The rheological properties of these emulsions were tested during a 30-day storage period at three different storage conditions (cold, room temperature and at 40°C). In addition to dynamic and static rheological tests, droplet size distribution of the cream was also determined. Furthermore, a stable simple emulsion was selected to realize percutaneous absorption and evaluate the properties of LipowheatTM. Résumé Ce travail a pour objectif de mettre à jour et d'évaluer les propriètés émulsionnantes d'un nouveau tensioactif de nature glucolipidique, connu jusqu'alors pour ses propriétés actives en cosmétologie: le LipowheatTM. Cette étude comporte plusieurs parties distinctes: 1) Formulation d'émulsions simples L/H et/ou H/L et multiples H/L/H stabilisèes par du LipowheatTM, avec des huiles variant par leur origine (naturelle ou synthétique) ainsi que par leur polarité. 2) Caractérisation rhéologique, granulométrique, et conductimétrique de ces émulsions après les avoir soumises pendant 30 jours à des conditions de vieillissement accéléré (conservation à température ambiante, à +4°C et +40°C) et ce, afin d'en retenir les plus stables pour la suite de l'étude. 3) Enfin, dans une dernière phase, les propriètés de ces crèmes dans le domaine de la libération dermopharmaceutique seront évaluées lors d'études in vitro. [source] Simultaneous determination of chlorinated bacteriostats in cosmetic and pharmaceutical productsINTERNATIONAL JOURNAL OF COSMETIC SCIENCE, Issue 6 2005L.-H. Wang A high-performance liquid chromatography method has been developed for simultaneous determination of triclosan (2,4,4-trichloro-2-hydroxydiphenyl ether) and triclocarban (3,4,4-trichlorocarbanilide) in cosmetic and pharmaceutical products. The two compounds could be separated on a Nucleosil C18 column and eluted with acetonitrile and water (70:30, v/v) as the mobile phase and detected with a differential refractive index detector. The retention times of triclosan and triclocarban were 5.81 and 2.99 min, respectively. The results obtained were in good agreement with those obtained by a differential pulse voltammetric method. [source] Review on the toxicity of ethylmercury, including its presence as a preservative in biological and pharmaceutical productsJOURNAL OF APPLIED TOXICOLOGY, Issue 1 2001L. Magos First page of article [source] A comparison of nine PLS1 algorithmsJOURNAL OF CHEMOMETRICS, Issue 10 2009Martin Andersson Abstract Nine PLS1 algorithms were evaluated, primarily in terms of their numerical stability, and secondarily their speed. There were six existing algorithms: (a) NIPALS by Wold; (b) the non-orthogonalized scores algorithm by Martens; (c) Bidiag2 by Golub and Kahan; (d) SIMPLS by de Jong; (e) improved kernel PLS by Dayal; and (f) PLSF by Manne. Three new algorithms were created: (g) direct-scores PLS1 based on a new recurrent formula for the calculation of basis vectors yielding scores directly from X and y; (h) Krylov PLS1 with its regression vector defined explicitly, using only the original X and y; (i) PLSPLS1 with its regression vector recursively defined from X and the regression vectors of its previous recursions. Data from IR and NIR spectrometers applied to food, agricultural, and pharmaceutical products were used to demonstrate the numerical stability. It was found that three methods (c, f, h) create regression vectors that do not well resemble the corresponding precise PLS1 regression vectors. Because of this, their loading and score vectors were also concluded to be deviating, and their models of X and the corresponding residuals could be shown to be numerically suboptimal in a least squares sense. Methods (a, b, e, g) were the most stable. Two of them (e, g) were not only numerically stable but also much faster than methods (a, b). The fast method (d) and the moderately fast method (i) showed a tendency to become unstable at high numbers of PLS factors. Copyright © 2009 John Wiley & Sons, Ltd. [source] Ehealth: Market Potential and Business StrategiesJOURNAL OF COMPUTER-MEDIATED COMMUNICATION, Issue 4 2001Pamela Whitten Due to the economic and social priorities afforded health services in the United States, research on new delivery modalities such as the Internet is gaining in popularity. Claims of the Internet's potential range from a promise to revolutionize the fundamental way health care is delivered to a tool for empowering patients through enhanced interaction with providers (Rice, 2001). Even though a great amount of attention has been given to e-health activity, the preponderance of publications to date has focused on the Internet as a source of health information. However important this form of e-health is, this type of service simply does not face the same constraints that must be addressed by those actually delivering health care services or tightly regulated pharmaceutical products. In this paper, we examine e-health by focusing explicitly on the delivery of health care products and services. Our examination of e-health activity is guided by two broad research questions. First, we ask what the potential is for the development of online health care services by examining its potential in major health care service and product sectors. Second, based upon case studies of two online health service firms, we seek to understand the emerging strategies of firms that are attempting to enter the health care market with an entirely online approach. Our examination of current e-health trends, as well as our two case studies, demonstrates the tremendous potential for health-related commercial activity on the Internet. However, our examination of the barriers facing ehealth from the US health system also pointed out the almost insurmountable challenges. We therefore conclude that a "click and mortar" model may perhaps be the optimal strategy for e-health. [source] A11. UV-related skin hazards: allergic photodermatitisJOURNAL OF COSMETIC DERMATOLOGY, Issue 2 2002Paolo Pigatto Cases of dermatitis induced by exposure to ultra-violet radiation are increasingly encountered in clinical practice, with contact allergic photodermatitis accounting for about 10% of cases. Its frequency seems to be increasing, not only as a result of the increased use of cosmetic products and contact with some of the materials of working processes, but above all because of the greater exposure to both natural and artificial sources of UV radiation. Many substances have been defined ,photo-allergising' but their exact prevalence has varied over the years with the introduction and use of new substances in cosmetics and pharmaceutical products. For these, and other reasons, there are few studies concerning the prevalence and incidence of contact allergic photodermatitis in Italy. A total of 2160 patients with clinical histories suggestive of photoallergic contact dermatitis were seen. All patients underwent photopatch tests with haptens proposed by the Gruppo Italiano Ricerca Dermatiti da Contatto plus other substances suggested by each patient's history. 518 patients (24%) were positive to at least one test substance of the standard series or to added substances. Typical photoallergic reactions were seen in 423 subjects, representing 19.5% of the total population. Topical drugs are the substances most frequently involved in photodermatitis. The incidence in our population was about equal for antimicrobial agents, additives to fragrances, and fragrances themselves. Other allergens frequently found were sun screening agents which were the second group of haptens with clear-cut relevance. [source] Free Amino Acids in Botanicals and Botanical PreparationsJOURNAL OF FOOD SCIENCE, Issue 5 2008B. Carratù ABSTRACT:, Numerous studies were carried out about aminoacidic composition of vegetable proteins, but information about the free amino acid pool and the role of these substances is very incomplete. The aim of this paper was to contribute to the scarce knowledge concerning the composition of free amino acids in botanicals and botanical preparations widely used as food, in dietary supplements, and in pharmaceutical products. This work studied the composition of free amino acids, identified the major components of 19 species of plants, and evaluated the influence of different types of extraction on the amino acid profile. Amino acids were determined using an automatic precolumn derivatization with fluorenylmethyl-chloroformate and reversed-phase liquid chromatography with fluorescence and ultraviolet detection. The amounts of total free amino acids varied widely between plants, from approximately 12 g in 100 g of Echinacea pallida extract to less than 60 mg in the same amount of Coleus forskohlii, Garcinia cambogia, and Glycine max. In 13 plants arginine, asparagine, glutamine, proline, and ,-aminobutyric acid were the free amino acids found in preponderant quantities. The levels of free amino acids above the quantification limit in 36 assayed samples of botanicals, extracts, and supplements are shown. [source] Variant Creutzfeldt-Jakob disease: An unfolding epidemic of misfolded proteinsJOURNAL OF PAEDIATRICS AND CHILD HEALTH, Issue 6 2002P Horby Abstract: Variant Creutzfeldt-Jakob disease (vCJD) is an emerging infectious disease believed to be the human manifestation of bovine spongiform encephalopathy (BSE). Variant CJD belongs to a family of human and animal diseases called transmissible spongiform encephalopathies (TSE). The pathogenesis of TSE is not fully understood, but a modified form of a normal cellular protein plays a central role. Current measures to control vCJD aim to prevent transmission of the infectious agent from animals to humans through food or pharmaceutical products and to prevent transmission from person to person via medical interventions. The anticipated development of preclinical diagnostic tests and treatments for vCJD will create new control options and difficult choices. [source] The role of entrepreneurial activities in academic pharmaceutical science researchJOURNAL OF PHARMACEUTICAL SCIENCES, Issue 6 2010Audra L. Stinchcomb Abstract Academic pharmaceutical science research is expanding further and further from the University setting to encompass the for-profit private company setting. This parallels the National Institutes of Health momentum to include multiple funding opportunities for University and private company collaboration. It has been recognized that the nonprofit and for-profit combination research model can accelerate the commercialization of pharmaceutical products, and therefore more efficiently improve human health. Entrepreneurial activities require unique considerations in the University environment, but can be modeled after the commercialization expansion of the academic healthcare enterprise. Challenges and barriers exist to starting a company as an entrepreneurial faculty member, but the rewards to one's personal and professional lives are incomparable. © 2009 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 99: 2532,2537, 2010 [source] Evaluation of a rotary tablet press simulator as a tool for the characterization of compaction properties of pharmaceutical productsJOURNAL OF PHARMACEUTICAL SCIENCES, Issue 6 2010F. Michaut Abstract The Stylcam 100R, a rotary press simulator, was designed to simulate speed profiles of rotary tablet presses. Such a simulator was qualified by numerous laboratories and, actually, its ability to be used for studying the behaviour of powders under pressure should be examined. Then, the purpose of this work was to investigate the performances of the Stylcam 100R for characterizing the compaction behaviour and the tabletting properties of pharmaceutical powders. The compressibility of three pharmaceutical excipients (microcrystalline cellulose, dicalcium phosphate dihydrate and ,-lactose monohydrate) was studied. Four compression speeds were used on the compaction simulator. Force,displacement cycles were associated with two energy parameters, the specific total energy (Estot) and the specific expansion energy (Esexp). The mean yield pressure was calculated from Heckel's plots obtained with the in-die method. The diametral tensile strength of compacts was measured in order to evaluate mechanical properties. To evaluate the accuracy of all these parameters, a comparative study was carried out on an eccentric instrumented press. The values of energy parameters and tensile strengths of tablets are close between the eccentric press and the compaction simulator, whatever the compression speed on the latter. The mean yield pressure values obtained using the two presses are different. Finally, the Stylcam 100R seems to be a good tool for characterising tabletting properties of powders, except for the Heckel's model probably due to an unadapted equation of deformation and a lack of accuracy of the displacement transducers. Future improvements should allow correcting these two points. © 2009 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 99: 2874,2885, 2010 [source] Characterization of amorphous solids with weak glass transitions using high ramp rate differential scanning calorimetryJOURNAL OF PHARMACEUTICAL SCIENCES, Issue 2 2008Derrick S. Katayama Abstract Measurement of the glass transition temperature (Tg) of proteins and other high molecular weight polymers in the amorphous state is often difficult, since the transition is extremely weak, that is, the ,Cp at the glass transition temperature is small. For example, little is known about the solid-state properties of hydroxyethyl starch (HES), which is beginning to become more commonly evaluated as a bulking agent in pharmaceutical products. For weak thermal events, such as the change in heat capacity at the Tg of a pure protein or large synthetic polymer, increased heating rate should produce greater sensitivity in terms of heat flow. Recent innovations in rapid scanning technology for differential scanning calorimetry (DSC) allow measurements on materials where the thermal events are difficult to detect by conventional DSC. In the current study, measurements of the Tg of proteins in the solid state, amorphous pharmaceutical excipients which have small ,Cp at the glass transition temperature, and bacterial spores, have all been made using high ramp rate DSC, providing information on materials that was inaccessible using conventional DSC methods. © 2007 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 97:1013,1024, 2008 [source] A risk-based approach to establish stability testing conditions for tropical countries,,JOURNAL OF PHARMACEUTICAL SCIENCES, Issue 5 2006Manuel Zahn Abstract The external stability risk factors heat and moisture are evaluated with respect to the development of pharmaceutical products intended to be marketed in tropical and subtropical countries. The mean daily temperatures and dewpoints measured four times per day at selected places in Southeast Asia, South America, China, Southern Africa and the Caribbean are used to calculate the daily and monthly fluctuations of temperature and partial water vapour pressure, the mean kinetic temperature and the relative humidity. Based on these data, the hottest and the most humid place in each country or region are identified to reflect the worst case for the specific region. A formula to calculate safety margins for temperature and partial vapour pressure is introduced taking into consideration the difference between measured meteorological parameters and the stability testing conditions. An appropriate long-term stability testing condition is proposed for each selected country, related to the worst case for each specific region and the safety margins, as well as its classification in either Climatic Zone IVA or IVB. © 2006 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 95:946,965, 2006 [source] Effects of PEGylation on the preservation of cationic lipid/DNA complexes during freeze-thawing and lyophilizationJOURNAL OF PHARMACEUTICAL SCIENCES, Issue 12 2002Taylor K.C. Armstrong Abstract The incorporation of components with covalently attached polyethylene glycol (PEG) into nonviral vectors has been shown to prevent aggregation in serum and extend the circulating half-life of lipid/DNA complexes (lipoplexes) in vivo. The tendency of synthetic vectors to aggregate during processing and storage also represents a significant obstacle in the development of lipoplexes as marketable pharmaceutical products. The extreme instability of lipoplexes formulated as aqueous suspensions has generated interest in preserving nonviral vectors as frozen or lyophilized formulations. Previous work has demonstrated that stabilizing excipients are capable of protecting lipoplexes during freezing and lyophilization, but there is little known about the ability of PEGylation to protect vectors during these stresses. This study incorporates up to 10% by weight dioleoyl phosphatidylethanolamine conjugated to PEG-2000 and PEG-5000 into lipoplexes and assesses the maintenance of particle size and transfection after agitation, freeze-thawing, and lyophilization. Our results indicate that the incorporation of PEGylated components alone (up to 10% by weight) is insufficient to preserve particle size during these stresses. However, when sucrose was employed in combination with PEGylated components, a small protective effect of PEGylation was observed. © 2002 Wiley-Liss, Inc. and the American Pharmaceutical Association J Pharm Sci 91:2549,2558, 2002 [source] Simultaneous determination of diethylene glycol and propylene glycol in pharmaceutical products by HPLC after precolumn derivatization with p -toluenesulfonyl isocyanateJOURNAL OF SEPARATION SCIENCE, JSS, Issue 16 2007Tao Zhou Abstract A simple and reliable HPLC method was developed for the simultaneous quantitative analysis of diethylene glycol (DEG) and propylene glycol (PG) in pharmaceutical products by precolumn derivatization. The derivatization reagent p -toluenesulfonyl isocyanate (TSIC, 10 ,L, 20% in ACN v/v) was added to 100 ,L of the sample, and then 10 ,L of water was added. The resulting derivatives were separated using a C18 analytical column and a mobile phase composed of 0.01 M KH2PO4 buffer (adjusted to pH 2.5 with phosphoric acid) and ACN (47:53 v/v) at 1 mL/min and 25°C. For detection, UV light at 227 nm was used. The derivatization conditions including reaction time, temperature, and concentration of TSIC were optimized. The calibration curves were linear from 0.062 to 18.6 ,g/mL (r2 = 0.9999) and from 0.071 to 21.3 ,g/mL (r2 = 0.9999) for DEG and PG, respectively. The RSD values of intra- and interday assays were all below 4% for DEG and PG. The proposed method was then successfully applied to analyze two Armillarisin A injection samples and two spiked syrup samples. [source] Utilization of prebiotic carbohydrates by yeasts of therapeutic relevanceLETTERS IN APPLIED MICROBIOLOGY, Issue 4 2001G. Mitterdorfer Aims: To investigate 17 strains of therapeutically relevant strains of Saccharomyces cerevisiae (including 10 strains of so-called S. boulardii) isolated from various pharmaceutical products, feed supplements and brewer's yeast for their capability of utilizing selected carbohydrates of prebiotic importance. Methods and Results: Automated turbidimetric measurements and conventional test combinations were used to examine the basic sugar assimilation profiles of the test strains. It was shown that none of the so-called S. boulardii strains utilized galactose and palatinose. Among the prebiotic substrates, the yeasts indicated a pronounced preference for metabolizing the fructo-oligosaccharides. Conclusions: Yeast strains of therapeutic relevance can be successfully combined with certain prebiotics in synbiotic formulations. Significance and Impact of the Study: The results of this study may serve as a basis for the development of new pharmaceutical preparations for medical therapy and a better understanding of intestinal micro-ecology. [source] Chemiluminescence determination of chlorpheniramine using tris(1,10-phenanthroline),ruthenium(II) peroxydisulphate system and sequential injection analysisLUMINESCENCE: THE JOURNAL OF BIOLOGICAL AND CHEMICAL LUMINESCENCE, Issue 1 2009Fakhr Eldin O. Suliman Abstract A sequential injection (SI) method was developed for the determination of chlorpheniramine (CPA), based on the reaction of this drug with tris(1,10-phenanthroline),ruthenium(II) [Ru(phen)32+] and peroxydisulphate (S2O82,) in the presence of light. The instrumental set-up utilized a syringe pump and a multiposition valve to aspirate the reagents [Ru(phen)32+ and S2O82,] and a peristaltic pump to propel the sample. The experimental conditions affecting the chemiluminescence reaction were systematically optimized, using the univariate approach. Under the optimum conditions linear calibration curves of 0.1,10 µg/ml were obtained. The detection limit was 0.04 µg/ml and the relative standard deviation (RSD) was always < 5%. The procedure was applied to the analysis of CPA in pharmaceutical products and was found to be free from interferences from concomitants usually present in these preparations. Copyright © 2008 John Wiley & Sons, Ltd. [source] Co-Crystallization and Characterization of Pharmaceutical IngredientsPARTICLE & PARTICLE SYSTEMS CHARACTERIZATION, Issue 3 2009Michael Herrmann Abstract Co-crystals may open the door to product tailoring of pharmaceutical products. Selected pharmaceutical ingredients were co-crystallized by mechanical and supercritical methods and the products were characterized by means of X-ray diffraction (XRD) using synchrotron radiation. The experiments revealed sub-micron and nano-structured composite particles, and three new phases, i.e., one cholesterol and two caffeine based. The phase separation and structure resolution of the new phases will form the aims of future investigations. [source] Consideration of regional difference in design and analysis of multi-regional trials,,PHARMACEUTICAL STATISTICS: THE JOURNAL OF APPLIED STATISTICS IN THE PHARMACEUTICAL INDUSTRY, Issue 3 2010H. M. James Hung Abstract Clinical trial strategy, particularly in developing pharmaceutical products, has recently expanded to a global level in the sense that multiple geographical regions participate in the trial simultaneously under the same study protocol. The possible benefits of this strategy are obvious, at least from the cost and efficiency considerations. The challenges with this strategy are many, ranging from trial or data quality assurance to statistical methods for design and analysis of such trials. In many regulatory submissions, the presence of regional differences in the estimated treatment effect, whether they are different only in magnitude or in direction, often presents great difficulty in interpretation of the global trial results, particularly for the acceptability by the local regulatory authorities. This article presents a number of useful statistical analysis tools for exploration of regional differences and a method that may be worth consideration in designing a multi-regional clinical trial. Published in 2010 by John Wiley & Sons, Ltd. [source] Potential population-based electronic data sources for rapid pandemic influenza vaccine adverse event detection: a survey of health plans,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 12 2008Kristen M. Moore MPH Abstract Purpose A vaccine against pandemic influenza may be rapidly and widely distributed, and could be used in populations with little prior exposure to influenza vaccines. Under such conditions, it will be important to gain timely information about the rates of vaccine adverse events, ideally by using electronic data from large populations. Many public and private health plans and payers have such information. Methods Between May and September 2007, we conducted a decision maker interview and technical assessment with several health plans in the United States. The interview and survey evaluated technical capability, organizational capacity, and willingness to participate in a coordinated program of rapid safety research targeting pandemic and other influenza vaccines. Results Eleven health plans (eight private, three public) participated in the decision maker interview. Most interviewees were medical directors or held similar positions within their organizations. Participating plans provided coverage and/or care for approximately 150 million members in the U.S. Nine health plans completed a technical assessment survey. Most decision makers indicated interest and willingness to participate in a coordinated rapid safety surveillance program, and all reported the necessary claims data analysis experience. Respondents noted legal, procedural, budgetary, and technical barriers to participation. Conclusions Senior decision makers representing private and public health plans were willing and asserted the ability of their organizations to participate in pandemic influenza vaccine safety monitoring. Developing working relationships, negotiating contracts, and obtaining necessary regulatory and legal approvals were identified as key barriers. These findings may be generalizable to other vaccines and pharmaceutical products. Copyright © 2008 John Wiley & Sons, Ltd. [source] New guideline for tramadol usage following adverse drug reactions reported to the Iranian pharmacovigilance center,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 2 2007K. Gholami Pharm D Abstract Background Tramadol was introduced as injection and oral form to Iranian Pharmaceutical Market in 2002. Shortly after, the injection form of the drug was observed at the top of suspected drug list of Adverse Drug Reactions (ADRs) received monthly by Iranian Pharmacovigilance Center (IPC). Objectives To detect, assess and report total number of Tramadol-induced ADRs received by IPC. To assess the frequency of reported Tramadol-induced ADRs before and after interventions. To design a guideline for prevention of probable ADRs due to Tramadol injection. Methods A descriptive study was conducted on spontaneous reporting received by IPC from April 2002 to February 2005. All ADRs suspected to be induced by Tramadol registered in the database during mentioned period were analysed. To assess the effect of different interventions based on Spontaneous Reporting System, the trend of reporting frequency of Tramadol-induced ADRs was evaluated before and after interventions. Results There were 337 cases of Tramadol-induced ADRs describing 939 reactions, reported to IPC during the study period. Although causal relationship had not been established, three cases of deaths appeared among the reports. The severity of reactions led to implementation of limitations on injectable Tramadol distribution to community pharmacies and the restriction of its use to hospitals only. Since most adverse reactions were dose-dependent, the drug potency of injectable Tramadol available in the country changed from 100,mg to 50,mg. The assessment of ADR reports received by IPC showed that the frequency of adverse reactions registered in the centre was reduced considerably following these interventions. Conclusion Designing a detailed programme by Pharmacovigilance Centres and closely monitoring of newly marketed pharmaceutical products is highly recommended. Copyright © 2006 John Wiley & Sons, Ltd. [source] Gas-phase formation of protonated benzene during collision-induced dissociation of certain protonated mono-substituted aromatic molecules produced in electrospray ionizationRAPID COMMUNICATIONS IN MASS SPECTROMETRY, Issue 11 2010Min Li Protonated benzene, C6H, has been studied extensively to understand the structure and energy of a protonated organic molecule in the gas phase. The formation of C6H is either through direct protonation of benzene, i.e., chemical ionization, or through fragmentation of certain radical cations produced from electron ionization or photon ionization. We report a novel observation of C6H as a product ion formed in the collision-induced dissociation (CID) of protonated benzamide and related molecules produced via electrospray ionization (ESI). The formation of C6H from these even-electron precursor ions during the CID process, which has not been previously reported, is proposed to occur from the protonated molecules via a proton migration in a five-membered ring intermediate followed by the cleavage of the mono-substituent CC bond and concurrent formation of an ion-molecule complex. This unique mechanism has been scrutinized by examining some deuterated molecules and a series of structurally related model compounds. This finding provides a convenient mean to generate C6H, a reactive intermediate of considerable interest, for further physical or chemical investigation. Further studies indicate that the occurrence of C6H in liquid chromatography/electrospray ionization tandem mass spectrometry (LC/ESI-MS/MS) appears to be a rather common phenomenon for many compounds that contain ,benzoyl-type' moieties. Hence, the observation of the C6H ion in LC/ESI-MS/MS can be used as an informative fragmentation pathway which should facilitate the identification of a great number of compounds containing the ,benzoyl-type' and similar structural features. These compounds are frequently present in food and pharmaceutical products as leachable impurities that require strict control and rapid elucidation of their identities. Copyright © 2010 John Wiley & Sons, Ltd. [source] Better Regulation of Industry-Sponsored Clinical Trials Is Long OverdueTHE JOURNAL OF LAW, MEDICINE & ETHICS, Issue 3 2009Matthew Wynia Regulating clinical trials for testing new drugs is fraught with risk. Misregulation can slow development of innovative and useful new drugs, but in other ways misregulation can foster trials that are inefficient and unethical, driven by commercial rather than scientific ends, and that can harm patients. In this paper, we argue not for more but for better regulation, based on the goal of rapidly producing innovative and safe products that represent significant advances in medical care. Data on industry-funded, late-stage clinical trials demonstrate an urgent need for dramatic changes in how these trials are designed, conducted, and analyzed. On the one hand, current patent rules can dissuade development of innovative new products with smaller markets and press trial designers to create positive results too rapidly. But at the same time, numerous studies show that when the pharmaceutical industry sponsors clinical trials, the results are systematically biased in favor of the sponsor's product, often to the detriment of patients and the public. The reasons for this bias are both complex and unavoidable, and the ways in which clinical trial design, conduct, and reporting can be inappropriately influenced are so varied and nuanced, that efforts to manage this conflict of interest and prevent harms are inevitably unsuccessful. Instead, we conclude such conflict should be avoided and a strong firewall should exist between drug developers and the final stages of clinical testing in humans. All financial support for phase III clinical trials should pass through a public-private partnership organization , perhaps tied to a broader clinical effectiveness research enterprise , which would be charged with designing, funding, and monitoring late-stage human clinical trials of new pharmaceutical products. [source] Intellectual Property Rights in Bilateral Investment Treaties and Access to Medicines: The Case of Latin AmericaTHE JOURNAL OF WORLD INTELLECTUAL PROPERTY, Issue 5 2006Rosa Castro Bernieri The link between intellectual property protection and access to medicines has been studied from different perspectives. After signing the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, most developing and least developed countries agreed to protect pharmaceutical products under the patent system. Beyond the criticisms of this system as an incentive mechanism to encourage private investment in research and development, it is widely acknowledged that a balance must exist between its benefits and costs. The patent system interaction with public health policies is twofold: providing incentives to develop new medicines, on the one hand, and increasing the prices of medicines, on the other. The TRIPS Agreement, the Doha Declaration and the subsequent Decision on Implementation of Paragraph 6 of the Doha Declaration all recognized this important trade-off. Different effects prevail in each interest group or country and negotiations of international intellectual property right (IPR) standards reflect this conflict. Nevertheless, the post-TRIPS scenario is full of new bilateral and regional agreements. The old bilateral investment treaties (BITS) are evolving towards new forms of all-encompassing arrangements that include intellectual property and liberalization of trade and services, apart from the classical rules for investment protection. This trend imposes a new landscape in IPR protection: one in which the above-described balance might be inclining towards one side. This article analyzes some legal, political and economic features of this new generation of BITS in Latin America. [source] The pattern of self-poisoning among Lebanese children and adolescents in two tertiary care centres in LebanonACTA PAEDIATRICA, Issue 6 2009Durriyah Sinno Abstract Aim: Self-poisoning in childhood and adolescence is a major problem for health authorities all over the world. The objective of this study was to determine the pattern of self-poisoning in Lebanese children and adolescents. Materials and methods: This prospective study included all cases of poisoning in individuals aged 0,18 years who presented to the emergency department of two major hospitals in Beirut, Lebanon over a period of 1 year. Participants were divided into two age groups (0,12 years and 12,18 years). These cases were followed to record the applied treatment and whether the patient was admitted or discharged. Results: There were 110 self-poisoning incidents, of which 74 (67%) were in female patients. The predominant type of poisoning was with pharmaceutical products (68.2%). Accidental self-poisoning was significantly more common in the younger age group among both genders compared with the older age group (p < 0.0001). There were significantly more poisoned male children (72%) than male adolescents (28%) (p = 0.003); whereas among females, poisoned adolescents were significantly more common (64%) than poisoned children (36%) (p = 0.009). Moreover, poisoning with pharmaceuticals was significantly higher in the young male group compared to the older age group and older female group compared to the younger age group (p = 0.0007 and p = 0.01, respectively). In total, 78% of patients were discharged home following basic observation, charcoal or gastric lavage. Conclusion: Female adolescents are more at risk of deliberate self-intoxication after the age of 12 years compared to males, whereas males younger than 12 years are more likely to suffer from accidental poisoning. Preventative strategies include screening adolescents at high risk of self-harm in order to offer adequate counselling, while providing anticipatory guidance for parents of children in the younger age group. [source] Determination of Epinephrine by Flow Injection Analysis Coupled Ag(III) Complex-Luminol Chemiluminescence DetectionCHINESE JOURNAL OF CHEMISTRY, Issue 4 2009Jiangbo BAI Abstract A new Ag(III) complex-luminol chemiluminescent system which was applied to the determination of epinephrine is firstly reported. Based on the enhancing effect of epinephrine on the chemiluminescence reaction of luminol with [Ag(HIO6)2]5, in alkaline solution, a highly sensitive chemiluminescence (CL) detection by flow injection analysis (FIA) was developed for epinephrine. Under the optimum conditions, CL intensity was proportional to concentration of epinephrine in the 1.0×10,9,1.0×10,7 mol·L,1 range. The limit of detection was 8.0×10,10 mol·L,1 for epinephrine (3,), with a relative standard deviation (n=11) of 2.9% for 1.5×10,8 mol·L,1 epinephrine. The method validation was done with epinephrine determinations in commercial pharmaceutical products. The mechanism of the reactions was also discussed. [source] | |||||||||||||||||||||||||