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Class of 2007 Abstract / Objectives: Despite the growing attention to the issue of patient utilizing foreign pharmaceuticals, the lack of scientific evidence makes it impossible to reach a conclusion about the topic. The objective of this study was to test the content of the active ingredient in three medications (warfarin, levothyroxine, and Viagra/sildenafil), obtained from the United States and Mexico, according to United States Pharmacopeia (USP) standards. Methods: The identification and quantification of the pharmaceutical products was determined utilizing normal and reversed phase high-performance liquid chromatography (HPLC). Each individual tablet was weighed , dissolved in an appropriate solvent, and sonicated to produce a sample for HPLC analysis. Twenty, ten, or six individual samples of each medication were analyzed twice via an appropriate HPLC method, depending on the number of tablets available. In addition, a bulk sample of twenty tablets was analyzed for both warfarin and levothyroxine to assess an average concentration for each sample. Results: The content of levothyroxine in the three Mexico medications was 87.0±2.3%, 104.7±3.1%, and 100.5±14.2%; compared to 98.4±1.4% in the US sample. Warfarin content analysis for the Mexican products resulted in an average of 98.5±2.6%, 95.9±1.1% and 94.8±1.8%; compared to 97.4±2.3% in the US sample. The sildenafil samples from Mexico were found to contain only 67.8±3.8% and 71.1±1.0% of what the US sample contained. Conclusions: Six out of the eight samples collected from Mexican pharmacies contained lower amounts of active ingredient than their US equivalents. In terms of the average concentration, many of the medications from Mexico fell within the USP range but there was great variation in the content of each individual tablet.

Class of 2007 Abstract / Objectives: The purpose of this study is to assess the quality of study medications obtained without a prescription through international websites. Methods: Samples of levothyroxine, warfarin, and sildenafil were obtained through various websites and compared to U.S. standards. Each sample was physically evaluated for weight, color, shape, and external tablet markings. High performance liquid chromatography (HPLC) was performed to quantify the amount of active ingredient. Results: When physically inspected, only 3 of the 9 lots met FDA labeling requirements. Three of 60 (20 tablets from 3 lots) of the individual levothyroxine tablets were out of the USP acceptable range (90% - 110%). For warfarin, 16 of the 60 samples (20 samples from 3 lots) of the individual tablets were out of the USP acceptable range (95% - 105%). When averaged, each of the lots for both levothyroxine and warfarin were within their USP acceptable ranges. As sildenafil is not available as generic in the U.S., there is no USP standard acceptable range for comparison. All of the sildenafil samples fell within 90%- 105% of Viagra® tablets obtained from a local pharmacy. Conclusions: While there were a few samples outside of the U.S. acceptable range, the majority of samples analyzed for active ingredient were within the range published in the USP. While the outcomes of this study presented interesting findings, further evaluation in larger studies is needed to properly assess the quality of foreign medications purchased over the internet.

The pharmaceutical market is a billon euro industry and the competition on the market is highly intensive. Primarily there are two competitors on the market, partly the originators which provide the market with new drugs, and partly the generics which produce copies of the originators‟ drugs. The originators are able to be granted patent protection of the drug under the European patent system, provided that the drug fulfils the requirements for patentability. During the period of patent protection the generics are not able to produce copies of the drug, but once the duration of the patent has expired the generics are able start the production. Thus, in order to hinder the generics to make copies of the drug, the originators apply various patent strategies. This has been noted by the European Commission, which conducted a sector inquiry of the pharmaceutical market in 2009. The presentation of the competition within the market focused on the applied strategies by the originator and concluded that all measures will be taken to hinder restrictions on the competition. In conjunction, the General Court judged in a recent case that the originator AstraZeneca constituted an infringement of the competition law when their strategies were applied. The complexity of determine whether a strategy is lawful or not, is due to the interface between the intellectual property law and the EC competition law. This implies that the strategy can be lawful under the IP law but unlawful under the competition law. The Court has established that any strategy, regardless of its legality under the IP law, constitutes an infringement of the competition law if it might restrict the competition. The Courts do not provide sufficient guidelines of the conditions that constitute the infringement. Consequently, the strategies‟ legality is at present time uncertain.

La presente investigación tiene como objetivo determinar aquellos factores que generaron el incremento de las importaciones de los productos farmacéuticos chinos en el Perú, entre los años 2013 al 2017. En principio, se analizaron las fuentes secundarias de la industria farmacéutica y las teorías de aplicación para entender mejor la industria y conocer los factores más relevantes que están impulsando el incremento de dichas importaciones chinas, sobre todo por tener un impacto directo con la salud y el bienestar de las personas. De acuerdo a la investigación exhaustiva en el marco teórico, se determinó que el capital y la mano de obra, diversificación, los costos logísticos, el régimen de políticas y la capacidad industrial, son factores determinantes que contribuyen al incremento de las importaciones de los productos farmacéuticos chinos en el Perú. En tanto, la metodología de trabajo aplicada corresponde a un estudio de tipo cualitativo – descriptivo, con diseño no experimental y que utiliza como instrumento de investigación a la entrevista en profundidad, cuyo resultado demostró que cuatro de los cinco factores son considerados determinantes con relación a nuestro tema de estudio. Es decir, el factor de la diversificación no fue considerado determinante para el presente tema de estudio. Debido a la investigación, se recomienda que la industria farmacéutica nacional y privada realice mejores prácticas empresariales con respecto a la utilización de estos factores de modo que puedan no sólo emular lo hecho por China, sino lograr elevar su competitividad en el mercado peruano hacia una industria farmacéutica más fortalecida. / This research aims to determine those factors that generated the increase in imports of Chinese pharmaceutical products in Peru, between 2013 and 2017. In principle, secondary sources of the pharmaceutical industry and application theories were analyzed to better understand the industry and to know the most relevant factors that are driving the increase in these Chinese imports, especially for having a direct impact on health and health. people's well-being According to the exhaustive research in the theoretical framework, it was determined that capital and labor, diversification, logistics costs, policy regime and industrial capacity are determining factors that contribute to the increase in product imports. Chinese pharmacists in Peru. Meanwhile, the applied work methodology corresponds to a qualitative - descriptive study, with a non-experimental design and that uses the in-depth interview as a research instrument, the result of which showed that four of the five factors are considered determinants in relation to Our subject of study. That is, the diversification factor was not considered decisive for the present subject of study. Due to the research, it is recommended that the national and private pharmaceutical industry make better business practices regarding the use of these factors so that they can not only emulate what China has done, but also increase their competitiveness in the Peruvian market towards an industry most strengthened pharmaceutical. / Tesis

Medicinal plants have played an important role in drug discovery, with many pharmaceutical products originating from plants. Isolation and characterization of antibacterial compounds is still relevant today because of continuing development of resistance of bacteria to antibiotics. The aim of the study was to evaluate the antibacterial activity of leaf extracts of nine tree species (Acalypha sonderiana, Androstachys johnsonii, Dracaena mannii, Drypetes natalensis, Funtumia africana, Necepsia casteneifolia, Oncinotus tenuiloba, Turraea floribunda, and Xylia torreana) selected from the Phytomedicine Programme Database based on good antimicrobial activities. The next step was to select the most active plant species and to isolate and characterize the antibacterial compounds. A serial microplate dilution method was used to determine the minimal inhibitory concentration and bioautography was used to determine the number of antibacterial compounds in the extract and their Rf values. Four nosocomial infection pathogens (Escherichia coli, Enterococcus faecalis, Pseudomonas aeruginosa, and Staphylococcus aureus) were used as test organisms. Extracts of all the plant species were active with average MIC values ranging from 0.13 to 2.0 mg/ml against the four bacteria. MIC values as low as 0.08 mg/ml was obtained with F. africana and O. tenuiloba extracts against S. aureus. In bioautography seven of the nine leaf extracts had activity with clear zones of inhibition on bioautograms against the red background. F. africana was active against all four bacteria while O. tenuiloba had selective activity against P. aeruginosa with clear bands on the bioautogram. F. africana was chosen for further investigation because (a) it had good antibacterial activity against the four tested bacteria with MIC value as low as 0.08 mg/ml, (b) there were several active compounds against all the tested bacteria based on bioautography, (c) it is common in nature, and (d) as far as our literature survey could ascertain there was no published information on the antimicrobial activity of this plant species. The bulk powdered leaves of F. africana were extracted with acetone. The acetone extract was fractionated into five fractions (hexane, chloroform, butanol, H2O and 30% H2O in methanol) using solvent-solvent fractionation, to group the phytochemicals based on their polarity. Hexane and chloroform fractions were the most active with MIC values as low as 0.02 mg/ml for the chloroform fraction. One of the traditional uses of F. africana is to treat burns. As a result, the crude extract and its five fractions were also tested for anti-inflammatory activity using both the COX-1 and COX-2 assays. The crude extract and the hexane and chloroform fraction had moderate activity against both cyclooxygenase 1 and 2. The chloroform fraction was more active than the crude extract (59.7 ± 1.4%)with an inhibition of 68.2 ± 6.6%. Because there was no activity in the aqueous extracts and traditional healers usually use water as extractant, the pain relief experiences traditionally must be due to another anti-inflammatory mechanism. One antibacterial compound was isolated from the hexane fraction using column chromatography with silica gel as the stationary phase and a hexane ethyl acetate gradient as the mobile phase from low to high polarity. The isolated compound was identified as methyl ursolate using nuclear magnetic resonance (NMR) and mass spectrometry. Methyl ursolate has been isolated from a number of plant species. However, this is the first report on the isolation from Funtumia genus and the first report of its antimicrobial activity. Previous phytochemical investigation from the stem bark of F. africana led to the isolation of steroidal alkaloids of the conanine group. Methyl ursolate had a low activity with MIC values of >250 μg/ml against the four tested bacteria, but had better activity against five fungal (Candida albicans, Cryptococcus neomeforms, Fusarium oxysporum, Penicillium janthinellium, and Rhizoctonia solani) species with an MIC value of 63 μg/ml against F. oxysporum. The chloroform fraction had excellent activity with an MIC of 20 μg/ml and may be developed to become a useful complex drug. The more than one hundred fold lower activity of the isolated methyl ursolate compared to the activity of the chloroform fraction from which it was isolated, provides strong evidence of synergism. This may be good model system for studying synergism in antimicrobial preparations. / Dissertation (MSc)--University of Pretoria, 2010. / Paraclinical Sciences / unrestricted

L'irrigation par les eaux usées est une pratique intéressante dans les régions arides et semi-arides où la ressource en eau subit une pression accrue. Cependant, cette pratique risque de contaminer les sols par des contaminants chimiques tels que les polluants organiques émergents comme les médicaments. Les mécanismes de transfert et de transformation de ces molécules sont encore peu connus. L'objectif de cette thèse a été d'étudier les processus de biodégradation et de sorption des médicaments en conditions contrôlées, avec une réflexion dans le contexte de la réutilisation des eaux usées pour l'irrigation. Nous avons exploité la signature chirale de l'antidépresseur venlafaxine (VEN) et de son métabolite humain majeur O-desméthyl venlafaxine (ODV) afin de discriminer le processus biologique et les processus abiotiques. Les résultats au laboratoire ont montré une corrélation entre le taux de biodégradation et le changement de fraction énantiomérique. La fraction énantiomérique de la VEN a été ensuite suivie à la sortie d'une STEP et dans une rivière recevant ce rejet, où un changement de la fraction énantiomérique a été observé, montrant l'intérêt de mieux développer cette approche pour des études de biodégradation in situ. Le processus de sorption des molécules cationiques VEN et ODV a été étudié avec deux approches, statique en batch et dynamique en colonne de lixiviation, avec une comparaison avec les molécules neutres carbamazépine et son métabolite trans-10,11-dihydro-10,11-dihydroxy carbamazepine. L'étude en batch a montré que pH et force ionique a influencé la sorption des molécules cationiques mais pas celle des molécules neutres. L'échange cationique pourrait ainsi jouer un rôle important dans la sorption des molécules cationiques. L'étude de la lixiviation a montré que les molécules neutres ont été plus mobiles que les molécules cationiques et elles sont susceptibles de contaminer l'eau souterraine dans le cas de l'irrigation par des eaux usées. / Wastewater irrigation represents great interest in arid and semi-arid regions where water demand is important. However, wastewater irrigation results in, for example, soil contamination by emerging organic pollutants such as pharmaceuticals. Transport and transformation mechanisms of these substances are still poorly understood. The objective of this thesis was to study the processes of biodegradation and sorption of pharmaceutical products in laboratory experiments, with a special reflection in the context of wastewater irrigation. Firstly, we exploited the chiral signature of the antidepressant venlafaxine (VEN) and its major human metabolite O-desmethyl venlafaxine (ODV) in order to discriminate the biological processes from other processes. Laboratory experiment showed a correlation between the biodegradation rate and the change in enantiomer fraction. The VEN was then monitored at the outlet of a WWTP and in the river receiving the discharge. A change in enantiomer fraction showed the interest for a better development of this application to investigate in situ biodegradation. Secondly, the sorption of cationic molecules VEN and ODV, as well as the neutral molecules antiepileptic carbamazepine and its human metabolite trans-10,11-dihydro-10,11-dihydroxy carbamazepine, was studied in batch and soil column leaching experiments. The pH and ionic strength conditions in batch experiment influenced the sorption of VEN and ODV, while there was little impact for neutral compounds. The cationic exchange should play an important role in the sorption process of cationic molecules. Leaching study showed that neutral compounds are much more mobile than cationic compounds; therefore they may contaminate groundwater in the case of wastewater irrigation.

Farmacijos pramonei yra taikomi vieni iš griežčiausių reikalavimų. Dėl šių reikalavimų labai sutrumpėja patento suteikiamos apsaugos trukmė produktui. Siekiant kompensuoti tokią sutrumpėjusią apsaugos trukmę, įvairiose valstybėse numatyta galimybė pratęsti patento, išduoto medicinos produktams, galiojimo laiką. Europos Sąjungoje patentų teisė nėra suderinta, tačiau suteikiant papildomą apsaugą medicinos produktams, yra priimtas vieningas sprendimas. Šis sprendimas – tai galimybė medicinos produktams išduoti papildomą apsaugos liudijimą. Bendrijoje nėra vienos kompetentingos institucijos, kuri išduotų tokį liudijimą. Jis yra išduodamas kiekvienoje valstybėje narėje tam tikros kompetentingos institucijos. Išduodant tokius liudijimus skirtingose valstybėse dažnai iškyla tam tikrų klausimų. Todėl darbe aptariamos papildomų apsaugos liudijimų medicinos produktams išdavimo problemos. Tyrimo tikslas – identifikuoti ir išanalizuoti papildomų apsaugos liudijimų medicinos produktams išdavimo probleminius aspektus. Analizuojant teismų praktiką bei specialiąją literatūrą apžvelgiami įvairūs probleminiai aspektai susiję su PAL išdavimu. Išvadose apibendrinama, jog PAL išdavimo medicinos produktams pagrindiniai probleminiai aspektai yra: a) susiję su Reglamente Nr. 469/2009 įtvirtintos sąvokos „produktas“ aiškinimu, b) susiję su minėtame Reglamente įtvirtintomis sąlygomis reikalingomis gauti PAL medicinos produktams, c) dėl „neigiamo“ galiojimo PAL išdavimo galimybės ir PAL galiojimo... [toliau žr. visą tekstą] / The pharmaceutical industry is subject to one of the most stringent requirements. Because of these requirements the duration of a product patent protection is much shorter. In order to compensate such reduced duration of protection different countries provide for a possibility to extend the period of a patent issued to medicinal products. The EU patent law is not consistent; however a unanimous decision has been adopted as to granting of extra protection to medicinal products. This solution is to issue a supplementary protection certificate with respect to medicinal products. There is no single competent authority in the Community, which is responsible for the issuance of such certificate. The relevant competent authority of each Member State issues a certificate. Often many questions arise in the course of issuance of such certificates in different countries. The paper discusses the problems concerning the issuance of supplementary protection certificates for medicinal products. The aim of the research is to identify and analyze problematic aspects of the issuance of supplementary protection certificates for medicinal products. The analysis of case law and special literature deals with various problematic aspects related to the issuance of SPC. The conclusions summarize the principle problematic aspects of the issuance of SPC for medicinal products, which are related with the following: a) Interpretation of the term "product" provided for in Regulation No. 469/2009; b)... [to full text]

The use of pharmaceutical products has steadily increased in the United States from 2 billion prescriptions in 1999 to 3.9 billion in 2009. Half of patients do not comply with the recommended prescription regimen and dispose of unused drugs in the environment. The U.S. Environmental Protection Agency and many researchers have highlighted the human-health risks associated with improperly disposing of pharmaceutical products. This quantitative cross-sectional study examined the potential correlations between people's actual disposal practices and their knowledge of the impact of disposal practices on the environment and human health, and availability of disposal options. The conceptual framework selected for this study comprised 2 models: the health belief model and the theory of planned behavior. Respondents to an online survey were 485 residents of the northeast United States, polled from the general population. Descriptive statistics and logistic regression were used to model responses from the dependent variable actual disposal practice (ADP) across the independent variables, and analysis of variance explored whether ADP differed across demographic variables. Statistically significant associations emerged among individuals' knowledge of environment and human-health impact, recommended disposal practices, disposal options, and that person's likelihood to practice recommended disposal. Demographic variables did not impact disposal behavior. To promote positive social change, it is recommended that policymakers plan and implement the expansion of convenient drug disposal options, as well as information campaigns on proper disposal practices. In parallel, health care professionals should stress to their patients the importance of complying with prescribed regimens, thus minimizing the amount of unused or expired medications.

Orientadores: Nelci Fenalti Hoehr, Marcos Nogueira Eberlin / Dissertação (mestrado) - universidade Estadual de Campinas, Faculdade de Ciências Médicas / Made available in DSpace on 2018-08-20T03:55:27Z (GMT). No. of bitstreams: 1 Amaral_PhellipeHonorio_M.pdf: 2853850 bytes, checksum: 1cdd86d86ade920d343377315ac2d392 (MD5) Previous issue date: 2012 / Resumo: Utilizou-se o maleato de enalapril para identificação dos produtos de degradação através da espectrometria de massas utilizando a técnica de ionização EASI (easy ambient sonic-spray ionization). Essa técnica de ionização ambiente torna a espectrometria de massas uma ferramenta mais simples, pois para esse trabalho não houve preparo de amostra, os ensaios foram realizados diretamente da superfície do comprimido. Para conhecermos melhor a rota de degradação do maleato de enalapril na formulação, comparou-se dois processos de fabricação dos comprimidos, a granulação via úmida e a compressão direta. Indicando grandes diferenças no perfil de degradação. A avaliação dos produtos de degradação foi feita em paralelo utilizando a técnica de separação por cromatografia líquida de alta eficiência com detector de ultra violeta, mostrando o comparativo das respostas da técnica EASI-MS e da CLAE -UV. Realizou-se os estudos de acordo com os estudos de estabilidade de longa duração, simulando assim a estabilidade do maleato de enalapril em comprimidos e um estudo de degradação forçada com o ataque ácido e térmico, demonstrando a capacidade da técnica em avaliar os estudos de degradação forçada / Abstract: We used the enalapril maleate to identify the degradation products by mass spectrometry using the technique of ionization EASI (easy ambient sonic-spray ionization). This technique makes the environment ionization mass spectrometry a more simple tool, as for this study there was no sample preparation, tests were performed directly from the tablet surface. To know the best route of degradation of enalapril maleate formulation, we compared two methods of manufacture of tablets, wet granulation and direct compression. Indicating large differences in degradation profile. The evaluation of the degradation products was performed in parallel using the technique of separation by high performance liquid chromatography with UV detector, showing the comparison of responses of the art EASI-MS and HPLC-UV. Studies were performed according to the studies of the long term stability, thus simulating the stability of enalapril maleate in a compressed and forced degradation study with heat and acid attack, demonstrating the ability of the technique of evaluating the degradation studies forced / Mestrado / Ciencias Biomedicas / Mestre em Ciências Médicas