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ABSTRACT Introduction: In hemodialysis, patients are exposed to a large volume of water, which may lead to fatal risks if not meeting quality standards. This study aimed to validate an alternative method for monitoring microbiological quality of treated water and assess its applicability in dialysis and dialysate analysis, to allow corrective actions in real-time. Methods: Validation and applicability were analyzed by conventional and alternative methods. For validation, E. coli standard endotoxin was diluted with apyrogenic water in five concentrations. For the applicability analysis, treated water for dialysis was collected from different points in the treatment system (reverse osmosis, drainage canalization at the storage tank bottom, reuse, and loop), and dialysate was collected from four machines located in different rooms in the hemodialysis sector. Results: The validation results were in accordance with the Brazilian Pharmacopoeia acceptance criteria, except for the last two concentrations analyzed. In addition, the ruggedness criterion performed under the US Pharmacopoeia was in agreement with the results. Discussion: A limiting factor in the applicability analysis was the absence of the endotoxin maximum permitted level in dialysate by the Brazilian legislation. When comparing the analysis time, the alternative method was more time-consuming than the conventional one. This suggests that the alternative method is effective in the case of few analyses, that is, real-time analyses, favoring corrective actions promptly. On the other hand, it does not support the implementation of the alternative method in a laboratory routine due to the high demand for analyses.

RESUMO Introdução: Na hemodiálise, os pacientes são expostos a um grande volume de água, o que pode levar a riscos fatais se não cumprir com padrões de qualidade. Este estudo teve como objetivo validar um método alternativo para monitorar a qualidade microbiológica da água tratada e avaliar sua aplicabilidade em análises de diálise e dialisato, para permitir ações corretivas em tempo real. Métodos: A validação e aplicabilidade foram analisadas por métodos convencionais e alternativos. Para validação, a endotoxina padrão de E. coli foi diluída com água apirogênica em cinco concentrações. Para a análise de aplicabilidade, a água tratada para diálise foi coletada em diferentes pontos do sistema de tratamento (osmose reversa, canalização de drenagem no fundo do tanque de armazenamento, reutilização e circuito) e o dialisato foi coletado em quatro máquinas localizadas em diferentes salas do setor de hemodiálise. Resultados: Os resultados da validação obedeceram aos critérios de aceitação da Farmacopeia Brasileira, com exceção das duas últimas concentrações analisadas. Além disso, o critério de robustez realizado sob a Farmacopeia dos EUA estava de acordo com os resultados. Discussão: Um fator limitante na análise de aplicabilidade foi a ausência do nível máximo permitido de endotoxina no dialisato pela legislação brasileira. Ao comparar o tempo de análise, o método alternativo consumiu mais tempo que o convencional. Isso sugere que o método alternativo é eficaz no caso de poucas análises, ou seja, análises em tempo real, favorecendo ações corretivas imediatamente. Por outro lado, não suporta a implementação do método alternativo em uma rotina de laboratório devido à alta demanda por análises.

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INTRODUCTION: In hemodialysis, patients are exposed to a large volume of water, which may lead to fatal risks if not meeting quality standards. This study aimed to validate an alternative method for monitoring microbiological quality of treated water and assess its applicability in dialysis and dialysate analysis, to allow corrective actions in real-time. METHODS: Validation and applicability were analyzed by conventional and alternative methods. For validation, E. coli standard endotoxin was diluted with apyrogenic water in five concentrations. For the applicability analysis, treated water for dialysis was collected from different points in the treatment system (reverse osmosis, drainage canalization at the storage tank bottom, reuse, and loop), and dialysate was collected from four machines located in different rooms in the hemodialysis sector. RESULTS: The validation results were in accordance with the Brazilian Pharmacopoeia acceptance criteria, except for the last two concentrations analyzed. In addition, the ruggedness criterion performed under the US Pharmacopoeia was in agreement with the results. DISCUSSION: A limiting factor in the applicability analysis was the absence of the endotoxin maximum permitted level in dialysate by the Brazilian legislation. When comparing the analysis time, the alternative method was more time-consuming than the conventional one. This suggests that the alternative method is effective in the case of few analyses, that is, real-time analyses, favoring corrective actions promptly. On the other hand, it does not support the implementation of the alternative method in a laboratory routine due to the high demand for analyses.

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This work proposed a procedure for microwave-assisted sample preparation of medicines using diluted nitric acid followed by determination of elemental impurities using inductively coupled plasma optical emission spectrometry (ICP OES) and inductively coupled plasma mass spectrometry (ICP-MS) according to the United States Pharmacopeia Chapters 232 and 233. Three solutions, i.e. inverse aqua regia, 7.0 and 2.0 mol L-1 HNO3, were evaluated for microwave-assisted digestion of nine drugs samples. The applicability of each digestion procedure was assessed by comparison of analyte concentrations determined using total (reference procedure) and partial digestions (proposed procedure) as well as by determining dissolved carbon content and evaluating matrix effects. There were none significant differences at a 95% confidence level among the concentrations determined applying reference and proposed procedures. Internal standardization (ICP OES) and aerosol dilution (ICP-MS) were applied for minimization and correction of matrix effects. Addition and recovery experiments were performed according to oral permissible daily exposures values specific for each element and each sample was spiked with element concentrations of 0.5J and 1.5J in order to check accuracies for 24 analytes. Recoveries ranged from 70 to 138% for ICP OES and from 72 to 128% for ICP-MS, for all elements but Os. All analytes were below the respective limits of quantification when applying all sample preparation procedures, except As, Ba, Co, Cu, Cr, Mo, Ni, Pb, Sb, Sn, Tl and V, however the determined concentrations for these elements were lower than the limits proposed by Chapter 232.

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ETHNOPHARMACOLOGICAL RELEVANCE: In spite of the rich bio-cultural diversity found in the Neotropics relatively few herbal drugs native to South America are included in the global pharmacopoeia. MATERIAL AND METHODS: In the attempt to historically explain the inclusion of herbal drugs into official pharmacopoeias we consider the disparate epidemiology and cultural evolution of the New and the Old World. We then trace the development of pharmacopoeias and review forces that worked towards and against the synchronization of pharmacopoeias and highlight the role of early chemical and pharmacological studies in Europe. Finally, we compare the share of exotic and native herbal drug species included in the Brazilian Pharmacopoeia with the share of exotic and native species included in the European Pharmacopoeia as well as those used for products registered with ANVISA. RESULTS: The domination of Eurasian herbal drugs in the European Pharmacopoeia seems to be conditioned by the geographical extension of Eurasia, which facilitated the interchange of materia medica and the creation of a consensus of use since ancient times. At the time of the Conquest the epidemiology of the Amerindian populations resembled that of pre-agriculturalist societies while no written consensus around efficacious medicine existed. Subsequently, introduced and well-tried plant species of the Old World gained therapeutic importance in the New World. CONCLUSION: The research focus in Europe and the US resulted in a persistence of herbal drugs with a historic importance in the European and US pharmacopoeias, which gained a status as safe and efficacious. During the last decades only few ethnopharmacological field-studies have been conducted with indigenous Amerindian groups living in the Brazilian Amazon, which might be attributable to difficulties in obtaining research permissions. Newly adopted regulations regarding access to biodiversity and traditional knowledge as well as the simplified procedure for licencing herbal medicinal products in Brazil prospects an interesting future for those aiming at developing herbal medicine based on bio-cultural diversity and respecting the protocols regulating benefit sharing.

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ETHNOPHARMACOLOGICAL IMPORTANCE: The Caatinga (semi-arid region), is an exclusively Brazilian biome. Considering the scarcity of ethnobotanical and ethnopharmacological studies in this region before the year 2000, this study presents data from ethnobotanical expeditions carried out between 1980 and 1990, by the late professor Francisco José de Abreu Matos (1924-2008). The information revealed in this present work are valuable and remained unpublished until now. MATERIALS AND METHODS: The objective was to organize, systematize and analyze ethnobotanical and ethnopharmacological data using ethnobotanical analytical techniques. The most cited native species in each use category were selected for literature review of the pharmacological studies related to their ethnomedicinal uses. RESULTS: Revision of the botanical nomenclature led to the botanical confirmation of 272 plants, of which 84 (30.9%) were reclassified. These represented 71 families and 220 genera that were cited 1957 times. 153 (56.3%) of these plant species are native to Brazil, of which 36 (23.4%) are endemic to the Caatinga. The use reports (RU) associated with these plants, according to the body systems (ICPC-2) in decreasing order of UR and the ICF values were respiratory system (93 species, 407 UR, ICF 0.77), digestive system (119 species, 373 UR, ICF 0.68), general and nonspecific symptoms (95 species, 219 UR, ICF 0.58), female genital system (60 species, 184 UR, ICF 0.68), skin (71 species, 156 UR, ICF 0.55), cardiovascular (50 species, 99 UR, ICF 0.50), blood and immune system diseases (46 species, 96 UR, ICF 0.53), urological (44 species, 88 UR, ICF 0.51), musculoskeletal (33 species, 80 UR, ICF 0.60), psychological (21 species, 71 UR, ICF 0.60), while others represent less than 10.0% of the UR. The most cited plants in the disease categories were Dysphania ambrosioides (28), Pombalia calceolaria (28) Hymenaea courbaril (26), Myracrodruon urundeuva (50), Brassica juncea subsp. integrifolia (16), Scoparia dulcis (22), Phyllanthus niruri (14), Egletes viscosa (25), Lippia alba (16), Erythroxylum vacciniifolium (9) and Salvia rosmarinus (21). The most prominent clades of the medicinal plants based on cluster analysis were the Lamiids (Euasterids)-497 UR and the Fabids (Eurosids I) - 468 UR. Association between certain phylogenetic clades and use-category were also observed and discussed. CONCLUSION: This study demonstrated a new approach in ethnopharmacology by mapping plant usages to diseases prevalent in a community from old ethnobotanical travel reports. In addition to revealing the therapeutic potential of Caatinga species using cluster analysis.

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ETHNOPHARMACOLOGICAL RELEVANCE: This article presents the results of a study on wild plant pharmacopeia and medical ethnobotany of the Wichí people of the South American Gran Chaco region, where native forest still persist. Few previous works on the former subjects exist, with only partial information. Traditionally, shamans are in charge of healing serious diseases and wild plants are used for treating minor problems. Some ethnobotanists believe that much of the present pharmacopeia of native peoples of the Gran Chaco comes from the Criollos (local non-native people) and that medicinal plants and uses would have been much fewer in the past. AIMS OF THE STUDY: The study aims to: a) document the wild medicinal plants used by the Wichís and the associated ethnobotanical knowledge, b) discuss the use of medicinal plants in the current sanitary, epidemiological and ethnomedical context of the Wichís, and c) analyse the similarities between the medicinal plants and uses of the Wichís and those reported for the Criollos of the study area, for the We'enhayek (Wichís of Bolivia) and for other indigenous peoples of the Gran Chaco. All of them will help to answer a general research question: are medicinal wild plants of the Wichís present pharmacopoeia long-dated or are they relatively new adquisitions? MATERIALS AND METHODS: Original data were obtained between 2005 and 2017 from 51 informants through open and semi-structured interviews, participant observation, "walks-through-the-forest" technique and gathering of plant vouchers. Consensus of Use (CU) per species, use, ailment and use-category were calculated. Species and uses of the Wichís and those reported for other groups of the region were compared confronting the data, a similarity index (Sorensen) was calculated and a cluster analysis was carried out. An interpretative analysis of the results was performed. RESULTS: Original data consist of 408 applications for which 115 plants of 48 botanical families are used for treating 68 ailments or symptoms. Species are mainly used for treating prevalent health disorders in Wichí epidemiological context (skin and digestive disorders, fever, respiratory affections) and feminine issues. CONCLUSIONS: The similarity of the current Wichí pharmacopoeia with the other ethnic groups of the region seem to respond more to a geographical proximity than to cultural affinity. Much (but not all) of their pharmacopoeia seem to be novel, resulting from a permanent seek for solutions to both old and new health problems in the native forests. Many medicinal plants, but not specific uses, seem to come from the neighbouring Criollos, whilst traditional remedies seem to be simultaneously preserved. Hence, I propose that the ethnobotanical "diversification hypothesis", slightly modified, applies in the case of wild medicinal plants of the Wichís, as new wild medicines are being added to the old ones to fill therapeutic vacancies that for several sociocultural and historical reasons appear in their traditional pharmacopoeia. Altogether, results provide novel information of interest for ethnopharmacology, medical ethnobotany and related disciplines, expand the knowledge of Wichí pharmacopoeia and constitute a baseline for future diachronic and cross-cultural studies in the Gran Chaco region.

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Pharmacokinetic interactions between natural products and conventional drugs can adversely impact patient outcomes. These complex interactions present unique challenges that require clear communication to researchers. We are creating a public information portal to facilitate researchers' access to credible evidence about these interactions. As part of a user-centered design process, three types of intended researchers were surveyed: drug-drug interaction scientists, clinical pharmacists, and drug compendium editors. Of the 23 invited researchers, 17 completed the survey. The researchers suggested a number of specific requirements for a natural product-drug interaction information resource, including specific information about a given interaction, the potential to cause adverse effects, and the clinical importance. Results were used to develop user personas that provided the development team with a concise and memorable way to represent information needs of the three main researcher types and a common basis for communicating the design's rationale.

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ETHNOPHARMACOLOGICAL RELEVANCE: French Guiana is a French overseas territory with a rich history of migration that has led to a highly intercultural society. Today, its population is one of the youngest in the French territory and is rapidly increasing. Despite a context of cultural revival seeking "tradition", a distanced baseline of local practices is still lacking. This work addresses some aspects of the cultural hybridizations in progress in urban areas. METHODS: Semi directed interviews were conducted with willing participants aged between 18 and 40. Interviews took place in French Guiana's two main urban centres: Cayenne and Saint Laurent du Maroni. People were interviewed about the last medicinal plant they used in the preceding year. Due to the high use of plant baths in French Guiana, a focus was made on baths. RESULTS AND DISCUSSION: Eighty-three people answered: 43 women and 40 men (mean age of 28.7 years old). In total, 226 remedies were counted in our study, 155 single plant remedies and 71 compound remedies leading to 316 use reports of plants from 16 cultural groups. A surprising number of 108 botanical species were recorded. Eighty-one recipes for baths were also collected. Despite this high citation rate, a rather low proportion of people declare a systematic and regular recourse upon local pharmacopoeia (46%; 38/83). Although many interviewees used plants, far from the majority used them on a regular basis. In practice, 50% of the species (54/108 spp.; 99/316 URs) are non-native but domesticated exotic species, imported from Asia, Europe, Africa or remote parts of America, either during colonization, the slave trade era, or more recently with the latest migrations. CONCLUSION: Although phytotherapy use is often thought to be related to countryside dwellers and older people, medicinal plants seem to play an important role in the lives of urban French Guianese youth. Research shows a large diversity of medicinal species used linked with the great cultural diversity of the Guianese cities. One characteristic of this population is the hybridization process leading to a perpetual renewal of practices, both in terms of species and practice.

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The aim of this study was to develop and validate a discriminating in vitro release test to evaluate rivastigmine transdermal patches. The Exelon® Patch was chosen as a model transdermal product. The studies of in vitro release were designed to determine the impact of the official apparatus chosen (USP apparatus 5 and USP apparatus 6), the rotation speed, and the dissolution medium characteristics on the rivastigmine release profile from transdermal patches. Patches with different drug release profiles were tested in order to evaluate the discriminating power of the in vitro release test developed and validated. Variables such as the apparatus type, the dissolution medium, and the rotation speed have a significant influence on the drug release characteristics from a transdermal patch. The in vitro release methodologies using the USP apparatus 5 at 50 rpm and USP apparatus 6 at 25 rpm using the medium phosphate-buffered saline pH 7.4 were considered discriminative and adequate to characterize the rivastigmine (RV) release from a commercial transdermal patch, Exelon® Patch.

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Se presenta una lista de remedios médicos basados en el uso de anfibios en la medicina popular española y en el Mundo Clásico. Se ha llevado a cabo una revisión de la bibliografía relativa a estudios de folklore, trabajos etnográficos e investigaciones en antropología social o médica. Se documenta un total de 113 remedios y el uso de nueve especies de anfibios, dos pertenecientes a la familia de los caudados (urodelos) y siete anuros. La mayoría de los remedios se basa en la "preconcepción" popular sobre la influencia de los mismos y la sanación mediante la transmisión del mal a un ser vivo. Se destaca el uso tradicional de algunas especies amenazadas, dato a tener en cuenta a la hora de tomar decisiones en el campo de la biología de la conservación y la educación ambiental.

This article presents a list of medical remedies based on the use of amphibians in Spanish popular medicine and in the classical world. It provides an overview of bibliography relative to folklore studies, ethnographic work and research on social or medical anthropology. It documents a total of 113 remedies and the use of nine species of amphibians, two from the family of caudates (urodeles) and seven anurans. Most of these remedies are based on the popular "preconception" about the influence of amphibians and healing by transmitting an illness to a living creature. The traditional use of certain threatened species is emphasized, an issue to bear in mind in decision-making in the field of conservation biology and environmental education.

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OBJECTIVE: This study examines the antiretroviral (ARV) market characteristics for drugs procured and prescribed to Mexico's Social Protection System in Health beneficiaries between 2008 and 2013, and compares them with international data. MATERIALS AND METHODS: Procurement information from the National Center for the Prevention and the Control of HIV/AIDS was analyzed to estimate volumes and prices of key ARV. Annual costs were compared with data from the World Health Organization's Global Price Reporting Mechanism for similar countries. Finally, regimens reported in the ARV Drug Management, Logistics and Surveillance System database were reviewed to identify prescription trends and model ARV expenditures until 2018. RESULTS: Results show that the first-line ARV market is concentrated among a small number of patented treatments, in which prescription is clinically adequate, but which prices are higher than those paid by similar countries. The current set of legal and structural options available to policy makers to bring prices down is extremely limited. CONCLUSIONS: Different negotiation policies were not successful to decrease ARV high prices in the public health market. The closed list approach had a good impact on prescription quality but was ineffective in reducing prices. The Coordinating Commission for Negotiating the Price of Medicines and other Health Supplies also failed to obtain adequate prices. To maximize purchase efficiency, policy makers should focus on finding long-term legal and political safeguards to counter the high prices imposed by pharmaceutical companies.

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ETHNOPHARMACOLOGICAL RELEVANCE: Ethnobotany is becoming an important tool for understanding how traditional medical systems are organized and which variables affect their structure and dynamics. However, some phenomena observed in ethnobotanical studies led us to question whether such phenomena are real or methodological artifacts. The small proportion of ferns and lycophytes in ethnobotanical surveys of medicinal plants is one such phenomenon, and its causes should be identified using different approach levels. The present study aimed to clarify the reasons for a low representation of these two groups in studies of medicinal plants. MATERIALS AND METHODS: The present study considered the following hypotheses: 1) ferns and lycophytes are little represented in different ethnobotanical studies because of inadequate data collection methods to record these species; 2) ferns and lycophytes are little represented because of the local perception of their low therapeutic efficacy; and 3) species of ferns and lycophytes are represented in local pharmacopoeias in proportion to the size of their families. We chose rural communities from Chapada do Araripe, Northeast Brazil to test our hypotheses. Data on the medicinal plant repertoires of the communities and on the perceived therapeutic efficacy of ferns were obtained using two different methods, semi-structured interviews associated with free lists and a checklist interview, both applied to local specialists. The resulting data were analyzed differently for each test. In addition, data regarding the total flora x medicinal flora ratio were obtained with a floristic survey and accessing data banks from previous studies performed by our research team. RESULTS: All hypotheses were confirmed, showing that all three factors contributed to the low representation of these plant groups as medicinal resources. The present study showed that free-list interviews are not a good method to access traditional knowledge of medicinal ferns and lycophytes and that the use of visual stimuli can help the memory of the informants, thus making it possible to associate the perceived characteristics with plant use. The results also showed that individuals perceive these plants as inferior therapeutic resources compared to angiosperms, which contributes to knowledge of their use not being transmitted. The final result of the present study was that the distribution of medicinal fern and lycophyte species within families was consistent with the total flora x medicinal flora ratio. This result indicates that even if the most appropriate data collection method was used for the ethnobotanical survey, the number of species would not be as expressive as that of angiosperms.

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A monografia farmacopeica da vacina tríplice viral (sarampo/caxumba/rubéola) exige a validação de desempenho do ensaio de potência utilizando-se apropriado material de referência (MR). Com o intuito de estabelecer o primeiro MR de trabalho (MRT) nacional para a vacina tríplice viral, foi realizado o estudo colaborativo nacional com a participação de duas únicas instituições que executam o ensaio de potência desta vacina, o Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos, produtor nacional) e o Instituto Nacional de Controle de Qualidade em Saúde.O material candidato (cMRTBio), preparado pelo produtor, foi avaliado pelos laboratórios participantes utilizando-se as respectivas metodologias in-house de determinação de potência. O cMRTBio foi considerado apropriado como MR in-house por estar em concordância com as especificações recomendadas nas normativas de compêndios, a saber: variações intra- (< 5 %), inter-ensaios (< 10 %) e entre laboratórios (< 10 %) abaixo dos limites aceitáveis; e potência estimada (log10 CCID50/DH) em 3,72 para sarampo, 4,80 para caxumba e 3,70 para rubéola. Este trabalho reflete o compromisso do único produtor nacional da vacina tríplice viral com a saúde pública, descrevendo-se a expansão da tecnologia, o cumprimento às diretrizes internacionais, o cuidado com o controle da qualidade e culminância para a autossuficiência nacional na produção de vacinas.

The pharmacopoeia monograph for the measles/mumps and rubella (MMR) triple vaccine demands to perform the validation of the potency assay by using the suitable reference material (MR). Aiming at establishing the firstwork MR (MRT) for the MMR triple vaccine, a national collaborative study was performed with the participation of the two unique national institutions working on the vaccine potency evaluation test, the Imunobiological Technology Institute (Bio-Manguinhos, national manufacturer) and the National Institute for Quality Control in Health. The candidate product (cMRTBio) prepared by the manufacturer was evaluated by the participant laboratories by employing the respective in-house methodologies for determining the potency. The cMRTBio was considered suitable as in-house MR, according to the specifications based on the normative compendia, being the intra-assay (< 5 %), inter-assay(< 10 %) and between laboratories variations (< 10 %) below the acceptable limits, and the estimate potency(log10 CCID50/DH) in 3.72 for measles, 4.80 for mumps and 3.70 for rubella. This study reflects the commitment of the unique national MMR vaccine producer to the public health, describing the expansion of technology,the compliance with international guidelines and the careful quality control, leading to the national self-sufficiency in the vaccine production.

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This article presents a list of medical remedies based on the use of amphibians in Spanish popular medicine and in the classical world. It provides an overview of bibliography relative to folklore studies, ethnographic work and research on social or medical anthropology. It documents a total of 113 remedies and the use of nine species of amphibians, two from the family of caudates (urodeles) and seven anurans. Most of these remedies are based on the popular "preconception" about the influence of amphibians and healing by transmitting an illness to a living creature. The traditional use of certain threatened species is emphasized, an issue to bear in mind in decision-making in the field of conservation biology and environmental education.

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AIM OF THE STUDY AND ETHNOPHARMACOLOGICAL RELEVANCE: This paper presents the first ethnobotanical survey conducted among the Achuar (Jivaro), indigenous people living in Amazonian Ecuador and Peru. The aims of this study are: (a) to present and discuss Achuar medicinal plant knowledge in the context of the epidemiology of this population (b) to compare the use of Achuar medicinal plants with the uses reported among the Shuar Jivaro and other Amazonian peoples. MATERIALS AND METHODS: The author conducted field research in 9 indigenous villages in the region of Morona Santiago and Pastaza in Ecuador. Semi-structured interviews on local illnesses and herbal remedies were carried out with 82 informants and plant specimens were collected and later identified in Quito. A literature research was conducted on the medicinal species reported by Achuar people during this study. RESULTS: The most reported medicinal plants are species used by the Achuar to treat diarrhoea, parasites infection, fractures, wounds, and snakebites. Informants reported the use of 134 medicinal species for a total of 733 recorded use-reports. Of these 134 species, 44 are reported at least 3 times for one or more specific disease condition for a total of 56 uses. These species are considered a core kit of medicinal plants of the Achuar of Ecuador. Most of these medicinal species are widely used in the Amazon rainforest and in many other parts of Latin America. CONCLUSION: The author documented a core kit of 44 medicinal plants used among the Achuar of Ecuador and found that this core set of medicinal plants reflects local epidemiological concerns and the pharmacopoeias of the Shuar and other Amazonian groups. These findings suggest that inter-group diffusion of medicinal plant knowledge had a prominent role in the acquisition of current Achuar knowledge of medicinal plants.

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In this work a method for active pharmaceutical ingredients (APIs) digestion using the single reaction chamber (SRC-UltraWave™) system was proposed following the new recommendations of United States Pharmacopeia (USP). Levodope (LEVO), primaquine diphosphate (PRIM), propranolol hydrochloride (PROP) and sulfamethoxazole (SULF) were used to evaluate the digestion efficiency of the proposed method. A comparison of digestion efficiency was performed by measuring the carbon content and residual acidity in digests obtained using SRC and in digests obtained using conventional microwave-assisted digestion system (Multiwave(TM)). Three digestion solutions (concentrated HNO3, aqua regia or inverse aqua regia) were evaluated for digestion of APIs. The determination of Cd, Ir, Mn, Mo, Ni, Os, Pb, Pd, Pt, Rh, Ru was performed using inductively coupled plasma mass spectrometry (ICP-MS) in standard mode. Dynamic reaction cell (DRC) mode was used for the determination of (51)V, (52)Cr, (53)Cr, (63)Cu and (65)Cu in order to solve polyatomic ion interferences. Arsenic and Hg were determined using chemical vapor generation coupled to ICP-MS (FI-CVG-ICP-MS). Masses of 500mg of APIs were efficiently digested in a SRC-UltraWave™ system using only HNO3 and allowing a carbon content lower than 250mg L(-1) in final digests. Inverse aqua regia was suitable for digestion of sample masses up to 250mg allowing the determination of Ir, Pd, Pt, Rh and Ru. By using HNO3 or inverse aqua regia, suitable recoveries were obtained (between 91 and 109%) for all analytes (exception for Os). Limits of quantification were in agreement with USP requirements and they ranged from 0.001 to 0.015µg g(-1) for all elemental impurities (exception for Os). The proposed method was suitable for elemental impurities determination in APIs and it can be used in routine analysis for quality control in pharmaceutical industries.

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In order to study the release characteristics of ketoprofen suppositories under the hydrodynamic environment generated by USP Apparatus 1 and 4, the dissolution profiles of the Mexican reference product (100 mg) were determined. Phosphate buffer pH 8 and 1% sodium lauryl sulfate (SLS) aqueous solutions were proved as dissolution mediums. Baskets were rotated at 100 rpm with USP Apparatus 1 and different flow rates from 16-32 mL/min with USP Apparatus 4 were used. Drug samples were taken and quantified during 60 min by UV analysis at 260 nm. Mean dissolution time (MDT) and dissolution efficiency (DE) were calculated by model-independent methods. Data were also fitted to several kinetic models. Poor dissolution was found in both dissolution mediums when USP basket method was used (< 10% dissolved) while better results were obtained with USP Apparatus 4 when 1% SLS at 24 mL/min was used (43.6% dissolved, MDT of 25.5 min and DE of 25.0%). Kinetics showed a great variability when the USP Apparatus 1 was used, and Gompertz fitted well for data of 1% SLS at 24 mL/min (R(2)(adjusted) > 0.99). The results suggest the need to establish an adequate dissolution method to evaluate the release kinetics of ketoprofen from suppositories.

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BACKGROUND: Data from an ethnobotanical study were analyzed to see if they were in agreement with the biochemical basis of the apparency hypothesis based on an analysis of a pharmacopeia in a rural community adjacent to the Araripe National Forest (Floresta Nacional do Araripe - FLONA) in northeastern Brazil. The apparency hypothesis considers two groups of plants, apparent and non-apparent, that are characterized by conspicuity for herbivores (humans) and their chemical defenses. METHODS: This study involved 153 interviewees and used semi-structured interviews. The plants were grouped by habit and lignification to evaluate the behavior of these categories in terms of ethnospecies richness, use value and practical and commercial importance. Information about sites for collecting medicinal plants was also obtained. The salience of the ethnospecies was calculated. G-tests were used to test for differences in ethnospecies richness among collection sites and the Kruskal-Wallis test to identify differences in the use values of plants depending on habit and lignifications (e.g. plants were classes as woody or non-woody, the first group comprising trees, shrubs, and lignified climbers (vines) and the latter group comprising herbs and non-lignified climbers). Spearman's correlation test was performed to relate salience to use value and these two factors with the commercial value of the plants. RESULTS: A total of 222 medicinal plants were cited. Herbaceous and woody plants exhibited the highest ethnospecies richness, the non-woody and herbaceous plants had the most practical value (current use), and anthropogenic areas were the main sources of woody and non-woody medicinal plants; herbs and trees were equally versatile in treating diseases and did not differ with regard to use value. Trees were highlighted as the most commercially important growth habit. CONCLUSIONS: From the perspective of its biochemical fundamentals, the apparency hypothesis does not have predictive potential to explain the use value and commercial value of medicinal plants. In other hand, the herbaceous habit showed the highest ethnospecies richness in the community pharmacopeia, which is an expected prediction, corroborating the apparency hypothesis.

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