Made available in DSpace on 2016-04-27T14:31:21Z (GMT). No. of bitstreams: 1 Valdenice Minatel Melo de Cerqueira.pdf: 4853814 bytes, checksum: 9f1ec9cc78787554a18c679826fce57d (MD5) Previous issue date: 2014-02-26 / This narrative-based work is attached to the line of research known as New Technologies in Education of Education Program: Curriculum from PUC - SP. This is a descriptive and qualitative-related study that evolved from the implementation of Dante Tablet program in Dante Alighieri School between 2011 and 2012. The overall objective of this work is to observe, describe and analyze the actions employed in the implementation of a program intended for the integration of information, communication, mobile and digital technologies into the curriculum of a school of basic education, while identifying the resiliencies arisen concerning this implementation. For this, we carried out analyses on documents that reveal the history and routine of the mentioned school, among them records of the institution s foundation, its Internal Regulations, accounts of meetings for training teachers, reports of students and teachers steering committees, notes of teaching practices, and questionnaires for teachers of tenth-grade secondary school and students of the Student Steering Committee. The journey to Paradise of the poet Dante Alighieri, described in the book "The Divine Comedy", was used as a metaphor of the methodological process. As to the narrative that supports this work, its development was conducted in a spiral manner, from the concept of Valente s spiral learning. In this paper, the idea of resilience, taken from Simpson and Tavares studies, refers to actions that provide the ability to overcome difficulties and adversities. In addition to these authors, the theoretical framework also comprehends Almeida with regard to issues on curriculum web and Freire over his view on education as an intervention in the world that enables change and transformation. Throughout the work, we identified four resilient actions that were predominant for the maintenance of Dante Tablet program, which are: the creation of the Student Steering Committee; the amplified use of Virtual Learning Environment (MOODLE); the identification, encouragement and enhancement of successful practices that favored aspects of students and teachers authorship; and the provision of a high-quality connection to the Internet, which allows activities involving since the simple ones, such as searching and selecting information, until those that promote students authorship and co-authorship as well as, in a collaborative way, the production and organization of knowledge through cloud computing. The verification of these actions was possible through some indicators that, established by Fullan, are called in this research vectors namely, need, clarity, complexity and quality. In addition to the identification of those resilient actions, another finding of this work was that the process of integration of digital technologies into curriculum should be designed and effected from a deep reflection and a broad dialogue, with the participation of each individual involved in the pedagogical task (in particular, teachers, students and administrators) so as to approach the subject from the perspective of a shared management of web curriculum, prioritizing an online integration of people, ideas, knowledge and cultures. Finally, the expectation is that this work can contribute to the debate on integration of mobile digital technologies into the curriculum within the Brazilian basic education / A presente investigação de natureza narrativa integra-se na linha de pesquisa das Novas Tecnologias em Educação do Programa Educação: Currículo da PUC-SP. Trata-se de um estudo descritivo, de natureza qualitativa, e que se desenvolveu a partir da implantação do programa Dante Tablet no Colégio Dante Alighieri entre os anos de 2011 e 2012. O objetivo geral da pesquisa é observar, descrever e analisar as ações empregadas na implantação de um programa de integração das tecnologias digitais móveis da informação e comunicação (TDM) ao currículo de uma escola de educação básica, identificando as resiliências surgidas nesse processo. Para tanto, foram feitas análises de documentos que deixam transparecer a história e o cotidiano do referido colégio, entre os quais: relatos sobre a fundação do colégio, Regimento Interno, atas de reuniões dos comitês de gestão (docente e discente), apontamentos de práticas pedagógicas dos professores, além de questionários para professores das 1ª séries do Ensino Médio e alunos do Comitê Gestor Discente. A viagem rumo ao Paraíso do poeta Dante Alighieri, descrita na obra A Divina Comédia , foi utilizada como metáfora do processo metodológico. Relativamente à narrativa que sustenta esta tese, seu desenvolvimento foi conduzido de maneira espiralada, a partir do conceito de espiral de aprendizagem de Valente. A resiliência, neste trabalho, remete às ações que oferecem capacidade de superar dificuldades e transpor situações adversas, e foi estudada a partir de Simpson e Tavares. Além desses autores, o aporte teórico também referencia Almeida nas questões de web currículo e Freire na perspectiva da educação como intervenção no mundo, possibilitando mudanças e transformações. Ao longo do trabalho, identificaram-se quatro ações resilientes que foram preponderantes para a sustentação do programa Dante Tablet: a criação do Comitê Gestor Discente; a utilização ampliada do ambiente virtual de aprendizagem criado no MOODLE; a identificação e valorização de práticas exitosas que favoreceram aspectos relacionados com a autoria de alunos e professores; e a oferta de uma conexão de qualidade com a internet, que possibilitou a realização de atividades desde as mais simples, como a busca e seleção de informações, até aquelas que promovem a autoria dos alunos e, de forma colaborativa, a produção e a organização do conhecimento por meio de serviços nas nuvens. A identificação dessas ações se deu por meio de alguns indicadores que, estabelecidos a partir do trabalho de Fullan, são chamados nesta pesquisa de vetores a saber, necessidade, clareza, complexidade e qualidade. Em complemento à identificação das ações resilientes, constatou-se que o processo de integração das tecnologias digitais ao currículo deve ser pensado e efetivado a partir de uma reflexão, de um diálogo, com a participação de todos os sujeitos do ato pedagógico (em particular, professores, alunos e gestores) na perspectiva de uma gestão compartilhada, do web currículo, priorizando uma integração, em rede, de pessoas, ideias, conhecimentos e culturas. Finalmente, a expectativa é a de que este trabalho possa contribuir para a reflexão sobre integração das tecnologias digitais móveis ao currículo, no âmbito da educação básica brasileira

A grande maioria da população mundial está crescentemente exposta à radiação eletromagnética proveniente de fontes que muitas vezes estão localizadas nas proximidades do corpo. A radiação eletromagnética é considerada um agente possivelmente cancerígeno para as pessoas, classificação 2B indicada pela Organização Mundial da Saúde-OMS (WHO/IARC, 2011). Devido às preocupações em relação aos riscos associados a esta exposição existem normas que recomendam os valores máximos de exposição permitidos (ICNIRP, 1998; FCC, 2001). A correta avaliação das doses de radiação é, portanto, relevante. Este trabalho tem a finalidade de avaliar o impacto dos resultados do cálculo da dose da Taxa de Absorção Específica (SAR) em usuários expostos a radiação por tablets operando na faixa de radiocomunicações Wi-fi. Os três modelos existentes de cabeça humana utilizados serão um manequim homogêneo SAM phantom e dois modelos de cabeça realistas heterogêneos: um adulto masculino e uma criança masculina. Será também utilizado nas simulações um modelo masculino de criança que foi desenvolvido através de imagens de tomografia computadorizada (TC) pelo processo de segmentação feito no software AMIRA. Será utilizado um modelo genérico de tablet. Os parâmetros dosimétricos usados para simulação da SAR serão computados pelo software SEMCAD X que é baseado no Método das Diferenças Finitas no Domínio do Tempo (FDTD). Será criado também um código do Método FDTD através do software MATLAB que servirá para a escolha dos parâmetros do SEMCAD X. A distância entre o tablet e os modelos de cabeças varia de 50 mm a 300 mm. Os resultados da SAR serão comparados com os limites de exposição recomendados pelas normas internacionais. Também serão simuladas diferentes posições da antena no tablet. Da análise dos resultados foi constatado que os valores de SAR são muito baixos e todos os resultados ficaram dentro dos limites do psSAR recomendados pela FCC de 1,6 W/kg em cada 1 g de tecido e de 2 W/kg em cada 10 g de tecido estabelecidos pela ICNIRP. Comparando os valores de SAR do modelo SAM com o modelo DUKE, o modelo SAM se mostra conservador, porém quando a comparação é feita com as crianças o SAM deixa de ser conservador. / The vast majority of the world population is increasingly exposed to electromagnetic radiation from sources which are often located near to the body. Electromagnetic radiation is considered a possible carcinogen for people, classification 2B indicated by the World Health Organization-WHO (WHO/IARC, 2011). Due to concerns regarding the risks associated with this exposition there are regulations suggesting maximum allowed exposure values (ICNIRP, 1998; FCC, 2001). The correct evaluation of radiation doses is therefore relevant. This work aims to assess the impact of the results of the calculation of Specific Absorption Rate dose (SAR) in users exposed to radiation from tablets operating in the Wi-fi band. The three existing models of human head used are a homogeneous dummy SAM phantom and two heterogeneous realistic head models: a male adult and a male child. It will also be used in the simulations a male child model which was developed from computed tomography (CT) imaging using the AMIRA software for the segmentation process. A generic model of tablet is used. Dosimetric parameters used for simulation of the SAR are computed using the SEMCAD X software which is based on the Finite Difference Method in Time Domain (FDTD). A FDTD code was developed using the MATLAB software in order to help to choose the input SEMCAD X parameters. The distances between the tablet and the head of the models varies from 50 mm to 300 mm. SAR results are compared with the exposure limits recommended by international standards. Different antenna positions on the tablet are simulated too. Examining the results it was found that the SAR values are very low and all results are within the psSAR limits recommended by FCC (1,6 W/kg averaged over 1 g of tissue) and by ICNIRP (2 W/kg in 10 g of tissue). Comparing the SAR in the SAM model with the SAR in the DUKE model, the SAM model shows to be conservative. However, when compared with the children, the SAM is not conservative.

Infusos e decoctos preparados com as partes aéreas de Solidago chilensis são utilizados na medicina popular para tratar distúrbios gástricos, úlceras intestinais, inflamações, reumatismo, além de outros empregos tais como diurético e analgésico. Diversos estudos têm sustentado conhecimento popular, como por exemplo, a atividade anti-inflamatória e gastroprotetora das partes aéreas de Solidago chilensis. Em modelos in vitro, in vivo e estudo clínico realizados com extratos obtidos com diversos solventes, foi observada tanto a resposta aguda quanto a crônica à inflamação. O mesmo ocorre para a ação gastroprotetora evidenciada para extratos aquosos em modelos in vivo. Com ampla e abundante ocorrência, essa espécie nativa do Brasil integra a Relação Nacional de Plantas Medicinais de Interesse do SUS (Renisus), inserindo-se na Política Nacional de Práticas Integrativas e Complementares (PNPIC). No entanto, não há relatos na literatura sobre a avaliação química e obtenção de produtos tecnológicos padronizados e ativos, o que constitui uma importante limitação para a produção de medicamento fitoterápico. Neste sentido, este trabalho objetivou, primeiramente, avaliar parâmetros de controle de qualidade e estabelecer critérios químicos que permitam identificar e caracterizar a espécie bem como compará-la a outras do gênero, que possuem amplo uso terapêutico na Europa. Análises comparativas destas amostras foram realizadas por CCD, CLAE e teor de flavonoides totais. Análises por CCD e CLAE dos extratos metanólicos demonstraram diferenças químicas interespécie e constância química qualitativa da S. chilensis em diversos locais e anos de coleta. A determinação quantitativa de flavonoides totais envolveu a otimização das condições de hidrólise ácida (concentração de HCl e do tempo de reação) e validação de método analítico por CLAE. O teor de flavonóides totais, assim obtido, foi 154% maior do que o observado por ensaio colorimétrico com cloreto de alumínio a 425 nm. Análises por CLAE-DAD e CLAE-EM/EM também foram realizadas e revelaram a presença de rutina, quercetrina e dos ácidos 3,4-O-dicafeoilquinico e 4,5-O-dicafeoilquinico. Além desses ensaios, ainda como parte da caracterização da droga vegetal, foi avaliado o teor e composição do óleo volátil presente nas folhas e inflorescências. Esses produtos demonstraram potente ação antifúngica frente a leveduras emergentes e multirresistentes, sem evidências de citotoxicidade. Em relação à obtenção do extrato seco por aspersão (PSA) a partir do extrato etanol:éter (1:1), o processo mostrou-se viável, com alto rendimento e para a sua qualificação química foram, empregadas duas técnica cromatográficas. Por CLAE foi determinada a presença dos mesmos componentes descritos para a droga. Adicionalmente, foi realizada a padronização química quantitativa da droga vegetal pela determinação dos flavonoides totais na qual foi evidenciando o teor de 82,73 mg/g expressos em quercetina. A quantificação da solidagenona foi realizada por HPTLC-densitometria e o teor médio encontrado foi de 8 mg/g. A avaliação da atividade gastroprotetora do PSA e do marcador solidagenona utilizou-se os modelos de lesão gástrica induzida por etanol e indometacina em camundongos. Nesses modelos, o PSA apresentou um índice de gastroproteção, nas doses de 50, 125 e 250 mg/kg respectivamente, de 85 ± 15%, 77 ± 3%; 83 ± 9%; 64 ± 16 % quando utilizado etanol como agente lesivo e de 63 ± 23% e 79 ± 12% quando utilizado a indometacina. A solidagenona testada na dose de 30 mg/kg, apresentou índices os índices de gastroproteção próximos aos dos padrões positivos ranitidina e carbenoloxona em doses de 100 e 200 mg/kg respectivamente. O PSA, produto intermediário com ação gastroprotetora, foi caracterizado como um pó fino com baixa densidade e baixa fluidez, tornando necessários processos de granulação por via seca para possibilitar a sua incorporação em forma farmacêutica sólida. Foram obtidos compridos de 700 mg e estes foram caracterizados em relação aos ensaios de resistência mecânica e uniformidade de conteúdo. Os resultados obtidos neste trabalho representam as primeiras contribuições para o estabelecimento de parâmetros e métodos para a caracterização que auxiliem no controle de qualidade da droga vegetal de S. chilensis. A viabilidade de produção, qualificação química e verificação de ação farmacológica do extrato seco obtido e o estudo da viabilidade tecnológica de obtenção de comprimidos contribuem enormemente para o desenvolvimento de novos produtos farmacêuticos a partir de S. chilensis. Este trabalho pode ser considerado inovador por tratar-se da associação de uma matriz complexa, rica em constituintes terpênicos e flavonoides cuja caracterização química quali e quantitativa foi estabelecida e demonstrada a viabilidade de inserção desta matriz em forma farmacêutica sólida. / Infusions and decoctions prepared with aerial parts of Solidago chilensis are used in folk medicine to treat gastric disorders, intestinal ulcers, inflammatory conditions, rheumatism, and as a diuretic and analgesic agent. The anti-inflammatory and gastroprotective activities attributed to the aerial parts have been observed in pharmacological studies, thus supporting the popular use for this species. Studies have demonstrated the inhibition of the chronic and acute inflammatory responses by extracts obtained with different solvents, through in vitro and in vivo models and also by a clinical trial. The same occurs to the gastroprotective action, evidenced for aqueous extracts in vivo. This species, native to Brazil and widespread throughout our country, is inserted in the RENISUS, which is part of the National Politics of Integrative and Complementary Practices. However, there are no reports in the literature concerning the chemical profile and the obtention of standardized technological products and their active principle, which may be an important limitation to the production of a phytomedicine. Following this line, the current work aims to add knowledge to the utilization for the species and also adds scientific evidences to the possibility of Solidago chilensis to follow into a phytotherapic productive chain. The objectives of this work are the evaluation of quality control parameters and the establishment of chemical conditions which may enable the identification and characterization of this species, as well as its comparison with other species belonging to the same genus, that share a wide therapeutic use in Europe. Comparative analyses for these samples were made by TLC, HPLC and also by the flavonoid total content profile. The analyses of methanolic extracts made by TLC and HPLC evidenced interspecies chemical differences and the qualitative uniformity for Solidago chilensis, observed in different places and years of collection. The quantitative total flavonoid determination involved the optimization of acid hydrolysis conditions (HCl concentration and time of reaction) and the validation of an analytic method by HPLC. The total flavonoid content thus obtained was 154% higher than the observed by the colorimetric assay using aluminum chloride, at 425 nm. Analyses by HPLC-PDA and HPLC-MS-MS were also conducted and revealed the presence of rutin, quercetrin, 3,4-O-cafeoyl quinic and 4,5-O-dicafeoyl quinic acids. Moreover, the vegetal drug characterization involved also the content and composition of volatile oil present in leaves and inflorescences. These products showed a potent antifungal action towards emerging and multiresistant yeast strains, without cytotoxicity evidences. The obtention of the spray-dried ethanol: ether (1:1) extracts demonstrated to be viable, with high yield, and their chemical standardization was achieved using two techniques. By HPLC, the presence of the same compounds described for the vegetal drug was determined. The quantitative content of total flavonoids was 82.73 mg/g, expressed as quercetin. Solidagenone content was assessed by HPTLC-densitometry, and was determined to be 8.0 mg/g. The gastroprotective activities of solidagenone and the Solidago chilensis spray-dried extract (SDE) were assayed using the ethanol and indomethacin-induced ulcer models. The index of ulceration induced by ethanol was reduced in the presence of SDE at the doses of 50, 125 and 250 mg/kg (85 ± 15 %, 77 ± 3 %; 83 ± 9 %; 64 ± 16 %, respectively); 64 ± 16 %, 63 ± 23 % e 79 ± 12 % in the presence of indomethacin. Solidagenone presented at the dose of 30 mg/kg an index of gastroprotection close to the reference standards ranitidine and carbenoxolone (100 and 200 mg/kg, respectively). SDE, the intermediary product with gastroprotective action, was characterized as a fine powder with a low density and a low flowability, making necessary the development of dry granulation processes to achieve its incorporation into solid dosages. This way, 700 mg tablets were obtained and characterized using the parameters mechanical resistance and uniformity of content. The results obtained in this work represent the first contributions to establish methods and parameters to the characterization and for the quality control of the vegetal drug Solidago chilensis. The viability of production, chemical standardization, assessment of the biological activity for the SPE and the technological feasibility to obtain tablets contribute to the development of new pharmaceutical products from Solidago chilensis. Considering that this complex plant matrix, enriched in terpenic and flavonoid constituents, has its qualitative and quantitative characterization already established, and that its insertion into a solid dosage has a viability of production, this can be considered innovator.

As Boas Práticas de Fabricação de Medicamentos (BPFM) enfatizam que a indústria farmacêutica deve dirigir seus esforços no sentido de compreender a variação do processo, incluindo as fontes, o grau de variação e o impacto dessa variação nas características de qualidade do produto. O processo de fabricação de medicamentos tem apresentado significativas mudanças, em especial no que se refere à introdução de tecnologias analíticas que permitem o controle do processo em tempo real. A abordagem baseada na análise de risco e no novo Sistema de Qualidade Farmacêutica constitui ponto central das BPFM para o século XXI. Os órgãos regulatórios têm exigido da indústria farmacêutica sua adesão na melhoria contínua relativa ao desempenho de seus processos e, por consequência, na qualidade do produto. O objetivo do presente trabalho foi o desenvolvimento e validação de método analítico empregando espectroscopia no infravermelho próximo, assim como a avaliação do processo de fabricação de comprimidos de Captopril 25 mg, empregando abordagem racional-científica. Com referência à avaliação do processo, foram adotadas as seguintes ferramentas: análise de modos e efeitos de falhas (FMEA); gráficos de controle; índices de capacidade e análise de variância (ANOVA). A espectroscopia por infravermelho próximo (NIR) foi selecionada por apresentar maior rapidez na obtenção dos resultados, maior simplicidade na preparação das amostras, multiplicidade das análises a partir de uma única leitura e por apresentar característica não invasiva. Os resultados comprovaram a adequação dessa tecnologia na avaliação quantitativa do Captopril nas etapas de mistura de pós e de compressão. Os desvios padrão relativos na determinação da uniformidade de Captopril na mistura de pós e nos comprimidos empregando método no NIR foram, respectivamente 3,15 e 0,18%. No que se refere à avaliação da estabilidade e da capacidade do processo, as ferramentas adotadas permitiram a compreensão das fontes de variabilidade, assim como a determinação de seu grau, nas diferentes etapas do processo. Os índices de capacidade (CpK) relativos à uniformidade de Captopril (% p/v) na mistura de pós, ao peso médio do comprimido, à uniformidade de conteúdo e à % (p/v) dissolvida de Captopril, no ensaio de dissolução, foram 0,70, 1,94, 1,80 e 2,19, respectivamente. / The Good Manufacturing Practices (GMP) for Medicinal Products point out that the pharmaceutical industry must direct efforts to understand the variation of the processes, including the sources, the level of variation and the variation impact on the process in characteristics of the product. The manufacturing process has shown meaningful changes, especially in the introduction of new analytical technologies that allow the process control in real time. The approach based on risk analyses and on the new Pharmaceutical Quality System is a central key for the GMP for the XXI century. The Regulatory Agencies have demanded the pharmaceutical industry to adhere the continuous improvement related to the performance of its processes and, consequently, the product quality. Thus, the present paper aimed the development and validation of the analytical method employing NIR spectroscopy as the assessment of manufacturing process of Captopril 25 mg tablets, using rational scientific approach. Regarding the process assessment, the following tools were adopted: analysis of failure modes and effects analysis (FMEA), control charts, capability indexes, as well as analysis of variance (ANOVA). The near-infrared spectroscopy was selected due to its greater speed in getting the results, simplicity in sample preparation, and multiplicity of analysis from a single reading and provide non-invasive feature. The results confirmed the suitability of this technology in quantitative assessment of Captopril on the steps of mixing powders and compression. The relative standard deviations for the determination of Captopril uniformity in the post mixtures and in the tablets employing NIR were 3,15 e 0,18%, respectively. In reference to the stability assessment and process capacity, the tools adopted permitted the understanding of the sources of variability, as well as the determination of their level in different phases of the process. The capacity indexes relating to Captopril uniformity (% p/v) in the powder mixture, the average weight of the tablet, the content uniformity and the % (p/v) dissolved Captopril, in the dissolution assay were 0,70, 1,94, 1,80 and 2,19, respectively.

Magister Pharmaceuticae - MPharm / Sutherlandia frutescens (tribe Galegeae, Fabaceae), is a popular medicinal plant traditionally used in South Africa. In 2000, a company called Phyto Nova (Pty) Ltd. initiated large-scale cultivation and contract manufacturing of tablets, made from the powdered herb (i.e. thin stems and leaves). Most of these commercial Sutherlandia solid dosage forms are made from the dried leaf powder but recently a new product, viz. Promune™ capsules, made from a freeze-dried aqueous extract, came on the market and was claimed to be “better” as it mimics the traditional tea. However, the pharmaceutical quality and stability of these preparations have not yet been investigated. The objectives of this study were firstly, to develop a validated stability-indicating HPLC assay for sutherlandioside B (SU-B); secondly, to compare the SU-B levels in the two commercially available Sutherlandia products viz, the Phyto Nova Sutherlandia SU1™ tablet and the Promune™ capsule, and, thirdly, to determine the effect of elevated temperature and humidity as well as acid hydrolysis on the SU-B levels in these two products. / South Africa

<p>The preparation of multiple unit tablets was investigated in this thesis with the intention of gaining a deeper understanding of some of the factors that influence the properties of such tablets.</p><p>Initially, three different types of pellets (drug, soft and disintegrant pellets) were combined as a model to investigate the ability of the mixture to form disintegrating tablets. The proportions of the different pellets and the type of disintegrant used were factors that independently influenced the tablet properties. Furthermore, the properties of tablets containing drug pellets barrier-coated with an aqueous polymer dispersion were also found to depend on the coating thickness and the compaction pressure.</p><p>When compacting pellets barrier-coated with a solvent-based polymer solution without incorporating excipient particles in the tablet formulation, a high pellet porosity was advantageous to preserve the original drug release profile, even though highly porous pellets became more densified and deformed than pellets of lower porosity.</p><p>The influence of the properties of excipient particles on the deformation<b> </b>of the reservoir pellets was also studied and, although the amount of flattening of the pellets was only slightly affected, changes in the pellet shape (irregularity) with alterations in the porosity and size of the excipient particles were more substantial. In contrast, the properties of the excipient particles did not affect the pellet densification.</p><p>The solvent-based coating used was able to adapt to the changes in volume and shape that the pellets underwent during compaction. The coating structure appears to be changed by compaction and it is proposed that the final structure of the coating is the net effect of two parallel processes, one reducing and one prolonging the transport time of the drug across the coating. Thus, the drug release could be maintained or even prolonged after compaction, despite extensive structural changes of the reservoir pellets.</p>

This dissertation describes two different projects. The first is the development of an oral DNA vaccine delivery system for fish. A novel oral DNA vaccine delivery system was developed for Rainbow Trout by combining non-viral vectors (polycationic liposomes or polycationic polymer) to facilitate the DNA vaccine's uptake by cell membranes along with enteric-coated protection of the DNA embedded in microparticles to prevent DNA degradation in the gastrointestinal tract. Spray drying and spray coating bead techniques were employed in the preparation of the DNA vaccine microparticles. The spray drying technique allowed production of spherical shape enteric-coated microparticles with a particle size range of 0.18 to 20 ��m. Larger particle sizes of 40-50 mesh were obtained from the spray-coated bead technique. The resultant DNA vaccine microparticles were granulated with regular fish feed and given to fish to investigate the efficacy of the delivery system in providing protection against IHNV, and to demonstrate the ease of administration in fish. An in vivo fish trial experiment showed improvement in fish survival rate when fish were immunized with larger particle size DNA vaccine microparticles. Further research to find effective vector carriers for the DNA vaccine delivery system and to seek modifications of the delivery system that will still prevent the denaturation of plasmid DNA that will also facilitate membrane uptake of the DNA vaccine is needed in order to develop a safe, effective, and commercially viable vaccine to control the outbreak of IHNV. The second project of the dissertation is prediction of in vitro drug release profiles from a novel matrix tablet spray-coated with a barrier membrane using mathematical and statistical models. Tablets were prepared by direct compression followed by spray coating. The relationship of the amount of hydrophilic materials in the core tablets and barrier thickness on drug release mechanism was investigated using factorial design and regression analysis. Drug release characteristics were influenced and can be controlled by modifying the amount of hydrophilic materials in the core tablet and the barrier thickness. Mathematical equation generated from regression analysis of n-value, lag time, and percent drug release as a function of the amount of hydrophilic material and the amount of coating material applied can now be used as a tool for predicting and optimizing in vitro drug release from matrix tablets spray-coated with a barrier membrane. / Graduation date: 2003

<p>Sutherlandia frutescens (tribe Galegeae, Fabaceae), is a popular medicinal plant traditionally used in South Africa. In 2000, a company called Phyto Nova (Pty) Ltd. initiated large-scale cultivation and contract manufacturing of tablets, made from the powdered herb (i.e. thin stems and leaves). Most of these commercial Sutherlandia solid dosage forms are made from the dried leaf powder but recently a new product, viz. Promune&trade / capsules, made from a freeze-dried aqueous extract, came on the market and was claimed to be &ldquo / better&rdquo / as it mimics the traditional tea. However, the pharmaceutical quality and stability of these preparations have not yet been investigated. The objectives of this study were firstly, to develop a validated stability-indicating HPLC assay for sutherlandioside B (SU-B) / secondly, to compare the SU-B levels in the two commercially available Sutherlandia products viz, the Phyto Nova Sutherlandia SU1&trade / tablet and the Promune&trade / capsule, and, thirdly, to determine the effect of elevated temperature and humidity as well as acid hydrolysis on the SU-B levels in these two products.</p>

The preparation of multiple unit tablets was investigated in this thesis with the intention of gaining a deeper understanding of some of the factors that influence the properties of such tablets. Initially, three different types of pellets (drug, soft and disintegrant pellets) were combined as a model to investigate the ability of the mixture to form disintegrating tablets. The proportions of the different pellets and the type of disintegrant used were factors that independently influenced the tablet properties. Furthermore, the properties of tablets containing drug pellets barrier-coated with an aqueous polymer dispersion were also found to depend on the coating thickness and the compaction pressure. When compacting pellets barrier-coated with a solvent-based polymer solution without incorporating excipient particles in the tablet formulation, a high pellet porosity was advantageous to preserve the original drug release profile, even though highly porous pellets became more densified and deformed than pellets of lower porosity. The influence of the properties of excipient particles on the deformation<b> </b>of the reservoir pellets was also studied and, although the amount of flattening of the pellets was only slightly affected, changes in the pellet shape (irregularity) with alterations in the porosity and size of the excipient particles were more substantial. In contrast, the properties of the excipient particles did not affect the pellet densification. The solvent-based coating used was able to adapt to the changes in volume and shape that the pellets underwent during compaction. The coating structure appears to be changed by compaction and it is proposed that the final structure of the coating is the net effect of two parallel processes, one reducing and one prolonging the transport time of the drug across the coating. Thus, the drug release could be maintained or even prolonged after compaction, despite extensive structural changes of the reservoir pellets.

<p>Sutherlandia frutescens (tribe Galegeae, Fabaceae), is a popular medicinal plant traditionally used in South Africa. In 2000, a company called Phyto Nova (Pty) Ltd. initiated large-scale cultivation and contract manufacturing of tablets, made from the powdered herb (i.e. thin stems and leaves). Most of these commercial Sutherlandia solid dosage forms are made from the dried leaf powder but recently a new product, viz. Promune&trade / capsules, made from a freeze-dried aqueous extract, came on the market and was claimed to be &ldquo / better&rdquo / as it mimics the traditional tea. However, the pharmaceutical quality and stability of these preparations have not yet been investigated. The objectives of this study were firstly, to develop a validated stability-indicating HPLC assay for sutherlandioside B (SU-B) / secondly, to compare the SU-B levels in the two commercially available Sutherlandia products viz, the Phyto Nova Sutherlandia SU1&trade / tablet and the Promune&trade / capsule, and, thirdly, to determine the effect of elevated temperature and humidity as well as acid hydrolysis on the SU-B levels in these two products.</p>