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Silva, Nathalia Cristina da Silva e. "Funcionalização do 3,4,6-tri-O-acetil-D-glucal com sais de organotrifluoroboratos de potássio e reações de click chemistry para a geração e funcionalização de triazóis." Universidade de São Paulo, 2013. http://www.teses.usp.br/teses/disponiveis/9/9138/tde-22042013-143833/.
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No presente trabalho, foi desenvolvida uma metodologia sintética para a funcionalização de um monossacarídeo derivado da D-glicose através do Rearranjo de Ferrier, utilizando-se um sal de organotrifluoroborato de potássio como nucleófilo. Em seguida, foi feita a reação de cicloadição azida-acetileno com cobre, através de estratégias simples e eficientes, que seguem a filosofia da click chemistry, permitindo a preparação de uma série de compostos com grande diversidade estrutural, possuindo dois anéis heterocíclicos e diversos substituintes, com promissora atividade biológica. Dando continuidade ao projeto, foi feita a metanólise dos grupamentos acetila, com carbonato de potássio e metanol. Assim, as novas moléculas adquirem maior hidrofilicidade e podem ser enviadas para novos testes biológicos, para fins de comparação com as anteriores. A partir dos compostos desprotegidos, foi feita a mesilação seletiva da hidroxila primária do açúcar e a substituição com selenolato de sódio, com a obtenção de seleno-carboidratos inéditos. Em uma segunda etapa do trabalho, exploramos a reatividade do núcleo triazólico, com a reação de troca Te/Li seguida de captura por eletrófilo. O material de partida foi sintetizado a partir do fenil acetileno. Com o triazol telurado em mãos, partimos para as reações de troca e captura por eletrófilo. Utilizamos diferentes tipos de eletrófilos, como aldeídos, cetonas, iodetos, dentre outros.We developed a synthetic methodology for the functionalization of a monosaccharide derived from D-glucose, using the Ferrier rearrangement with a potassium organotrifluoroborate salt as the nucleophile. This way, a series of coumpounds with high structural diversity and two heterocyclic rings having different substituents were produced, using the azide-acetylene cycloaddition reaction. Through this simple and efficient methodology, that follows the \"click chemistry\" philosophy, we could synthesize molecules with promising biological activity. Continuing the project, we performed the methanolysis of the acetyl groups, with potassium carbonate and methanol. Thus, the new molecules become more hydrophilic and could be sent to new biological tests, for a comparison with the previous ones. From the deprotected compounds, we were able to mesilate the primary hydroxyl and substitute it with sodium selenolate, obtaining novel selenium-carbohydrates. In a second part of our work, we were able to exploit the triazole reactivity trough the Te/Li exchange reaction followed by the electrophile capture. The starting material was obtained from phenyl acetylene. With the teluratte in our hands, we set out to the exchange reactions, using several types of electrophiles, such as aldehydes, ketones, iodide, among others.
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Canduzini, Hugo Antonio. "Síntese e funcionalização de 1,2,3-triazóis via reação de cicloadição [3+2] de azidas e acetilenos terminais." Universidade de São Paulo, 2012. http://www.teses.usp.br/teses/disponiveis/9/9138/tde-07032013-094439/.
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O objetivo deste trabalho é explorar a síntese e funcionalização de 1,2,3- triazóis empregando o uso de reações do tipo \"Click-chemistry\", que é uma abordagem para a síntese de diversos compostos com base em reações de formação de ligação carbono-heteroátomo, onde a reação é estereoespecífica, altamente eficiente e geralmente com elevados rendimentos e em alguns casos ausência de subprodutos. O composto 1,2,3-triazol, sendo o material de partida para a continuidade do projeto foi preparado a partir do álcool propargílico (4) em presença de uma azida orgânica (1) e utilizando cobre(I) como agente promotor. Após a obtenção de uma série de compostos 1,2,3-triazólicos (2), procedeu-se a etapa de tosilação da hidroxila e posterior cicloadição multicomponente de um novo 1,2,3-triazol formando compostos bis-triazólicos. Os bis-triazóis (5) obtidos foram testados frente a cepas fúngicas, responsáveis por dermatites, com resultados satisfatórios. Ainda essas estruturas poderão ser empregados como blocos construtores para a síntese de estruturas mais complexas.The aim of this work has been exploring the synthesis and functionalization of 1,2,3-triazoles employing the use of \"click-chemistry\" concept, which is defined as an approach for synthesis of various compounds based on reactions of carbon-heteroatom bond formation, which the reaction is stereospecific, high-efficiently, commonly gives high yields and in some cases no by-products are formed. The compound 1,2,3-triazole, which is the main starting material for the next steps was prepared from propargyl alcohol (4) in the presence of an organic azide (1) and copper(I) as a reaction promoter. Subsequently with a series of 1,2,3-triazole (2n) prepared we proceeded to the next step which is the substitution of hydroxyl for a tosyl group and after that a multicomponent cycloaddition of a new 1,2,3-triazole compound forming bis-triazoles. Bis-triazoles (5) were tested against fungal strains, responsible for dermatitis, with delighted results, furhtermore this class of strutures can be used as building blocks to improve efficiency in some other more complex structure.
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Conté, Jennifer. "Intensification of pharmaceutical production : from the raw materials to the crystallized active pharmaceutical ingredient." Thesis, Toulouse, INPT, 2016. http://www.theses.fr/2016INPT0015.
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L’un des nombreux défis pour l’industrie pharmaceutique est de développer des procédés compétitifs pour produire des principes actifs de hautes qualités à bas coût. Pour ce faire, plusieurs sociétés se tournent vers la chimie en flux continu et les avantages qu’elle présente comparé au batch traditionnel. C’est pourquoi ces travaux de thèse se centrent sur le développement d’un procédé continu allant des matières premières au principe actif. La première étape pour parvenir à ce but fut de collecter des données sur le procédé batch industriel actuel. Il se compose de trois étapes de réactions chimiques, une de séparation chromatographique et une étape de cristallisation. A partir de là, la chimie de chaque réaction a été adaptée pour profiter au mieux des avantages du flux continu. La dissipation de chaleur étant plus efficace qu’en batch il fut possible de développer une réaction exothermique sans solvant à haute température. Une étude cinétique a été réalisée afin de modéliser cette réaction. Ensuite, cet outil fut utilisé pour déterminer les conditions opératoires optimales théoriques de la réaction et en guider l’optimisation ainsi que la conception du futur réacteur. La deuxième partie de ce travail se focalise sur la cristallisation en continu du principe actif avec la technique des jets impactant. Il est nécessaire d’avoir un contrôle précis sur la distribution de taille de particules (DTP) et la morphologie des cristaux. En effet, le principe actif peut cristalliser sous deux formes compétitives : cristaux cubiques ou en forme d’aiguilles. Les cubes sont la forme désirée. La technique des jets impactant a été sélectionnée car c’est un procédé continu qui permet la génération de fines particules avec une DTP resserrée. La sursaturation est généralement crée en impactant un jet de solution de principe actif avec un jet d’anti-solvant. Ici, le solvant et l’anti-solvant sont les mêmes. Seule une large différence de température entre les deux jets génère la sursaturation. En testant différentes conditions opératoires, une « zone cubique » a été définie, où seuls des cristaux de forme désirée sont générés. Une fois la nucléation maîtrisée, le murissement et la séparation solide-liquide furent étudiés pour développer un procédé complet de cristallisation. En combinant les recherches sur le développement des réactions chimiques et l’étape de cristallisation, un procédé continu complet fut proposé et comparé au procédé batch actuel afin d’évaluer les bénéfices apportés par la transposition en flux continu à la production du principe actifOne of the many challenges in the pharmaceutical industry is to develop competitive processes to generate high quality active pharmaceutical ingredient (API) at low cost. To achieve this goal, many companies are looking towards flow chemistry and the advantages it affords, compared to traditional batch production. It is why this PhD work is focused on developing a continuous process from the raw materials to the API. The first step to achieve this goal was to collect data on the actual industrial batch process. It is composed of five steps, three steps of chemical reactions, one chromatographic separation and a crystallization step. From this starting point, the chemistry of each reaction was adapted to better use the advantages of flow chemistry. Thus, as the heat recovery in a continuous reactor is more efficient than in batch, it was possible to develop an exothermal reaction in neat conditions and at high temperature. A kinetic study was undertaken to gather knowledge on the reaction and develop a reaction model. This tool was used to find theoretical optimal operating conditions (temperature, residence time…) to guide the optimisation of the reaction and to design the future industrial reactor. The second part of this work is focused on the continuous crystallization of the API using the two impinging jets technology. It is required to have a tight control upon the morphology of the crystals and the particle size distribution (CSD). Indeed, the targeted API may crystallize under two competitive forms: cubic and needle crystals. The cubic form is the desired one. The two impinging jets technique was selected, since it is a continuous process able to generate small particles with a narrow CSD. The supersaturation is traditionally generated by impacting a jet of API solution with an anti-solvent one. Here, the solvent and the antisolvent are identical and only a large temperature difference between both streams is used to create the supersaturation. By screening different operating conditions, a “cubic zone” could be defined. Within this zone, only the desired crystal form is generated. Once the nucleation was under control, crystal growth and solid-liquid separation were studied to develop a complete crystallization process. By combining the research on the development of the chemical reactions and the crystallization step a full continuous process was proposed and was compared to the current batch one in order to evaluate the benefits brought by the flow chemistry to the API production
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Grazier, Jeffery N. "Characterisation of amorphous pharmaceutical materials." Thesis, Loughborough University, 2013. https://dspace.lboro.ac.uk/2134/12986.
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Small quantities of amorphous content can have a profound influence on the properties of a material, however their instability means that quantifying amorphous content over time is important for proving the stability of a drug. Quantifying amorphous content in α-lactose monohydrate by solid state 13C CP MAS NMR, has been carried out by use of proton saturation recovery relaxation and differentiating between spectra by partial least squares (PLS), however these techniques have not proved sensitive on their own, this work investigates their sensitivity in combination. Crystalline α-lactose monohydrate and a rapidly quenched melt were combined to create a set of calibration mixes, whose spectra were recorded using proton saturation recovery relaxations ranging from 2 to 60 seconds. This technique showed a limit of detection of 0.17% (LOD = intercept + 3xSy/x), with a relaxation delay of 15 s and was able to recognise amorphous materials generated by spray and freeze drying. The atmospheric effects on the proton saturation recovery relaxation times of different amorphous lactose preparations were investigated. This found that an oxygen atmosphere reduced the relaxation times, of amorphous lactose that was prepared from a rapidly quenched melt. The loss of moisture from spray dried and freeze dried samples to less than 1% removed the significance of this effect. Lactose is an important excipient in pharmaceuticals and a key ingredient of confectionary, very little research has been carried out in to the quantification of the isomers of different preparations of amorphous lactose. This work quantifies the isomer content by Gas Chromatography with Flame Ionisation Detection (GC-FID) using a DB-17 15m 0.53mm 1.00 μm column and derivatisation with N- (trimethylsilyl)imidazole.
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Khor, Si Ming Thomas. "The study of inventory management of raw materials for a pharmaceutical company." Thesis, Massachusetts Institute of Technology, 2007. http://hdl.handle.net/1721.1/42320.
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Thesis (M. Eng.)--Massachusetts Institute of Technology, Dept. of Mechanical Engineering, 2007.Includes bibliographical references (p. 91).
TCG is a multinational pharmaceutical company. As part of its drive to adopt lean manufacturing methodology in the plant and to stay competitive in the industry, TCG plans to effectively maximize its capital assets and reduce the warehouse space from 3500 to 1500 pallet spaces. This thesis focuses on the raw materials procurement and ordering methods in TCG. We study the accuracy of the demand forecasts for the finished products. And we investigate methods to improve procurement and inventory control. We use a 2-factor classification method to rank the 38 types of raw materials in the warehouse in terms of their importance based on their past procurement costs and the amount of warehouse space they occupied. We propose a just-in-time approach for the 9 most important items by having timely orders that match closely to the production schedule. A continuous review model is used for the next 11 items of less importance and a periodic review model is used for the remaining 18 items, which are of the least importance. We discuss and justify the assumptions used in our analysis. We provide a few further recommendations on how to improve inventory control based on observations of the current practices. The overall result shows that it might be possible to reduce the amount of space occupied by raw materials from the current average of 1076 pallets by 72%.
by Si Ming Thomas Khor.
M.Eng.
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Konrad, Rainer Wilhelm. "Planejamento e controle das matérias-primas na produção de medicamentos em Farmanguinhos." reponame:Repositório Institucional da FIOCRUZ, 2016. http://www.arca.fiocruz.br/handle/icict/15037.
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Fundação Oswaldo Cruz. Instituto de Tecnologia em Fármacos/Farmanguinhos. Rio de Janeiro, RJ, Brasil.
A produção de medicamentos como a maioria da produção de produtos manufaturados, requer matérias-primas as quais necessitam inicialmente de um planejamento eficaz e depois um controle eficiente para que o produto final seja entregue nas condições requeridas. A falha no processo de aquisição dos insumos pode resultar negativamente em toda a cadeia produtiva. Farmanguinhos como Laboratório Farmacêutico Oficial (LFO) deve seguir a Lei nº 8.666 de 21 de junho de 1993, que trata do processo de aquisição, o que torna a atividade mais complexa assim como a atividade de Planejamento e Controle da Produção. Assim, o presente trabalho tem como objetivo principal analisar o sistema de suprimento de Farmanguinhos e propor melhorias no planejamento e controle de matérias-primas. Foi realizado um estudo descritivo tendo como estratégia metodológica o estudo de caso referente à Farmanguinhos. Foram realizados cálculos entre os tempos estimados e reais para cada etapa do processo produtivo de antirretrovirais no LFO em questão. Ademais, foram buscadas informações referentes a experiências de outros LFO e por fim foram elaboradas propostas de melhoria. No que tange ao atendimento ao cliente, Farmanguinhos não tem tido bom desempenho, uma vez que apenas 24% dos pedidos foram atendidos no prazo. Possui em tempo médio de atendimento para os anos 2010 a 2014 de 395 dias reais contra uma expectativa do principal cliente, o Ministério da Saúde, de 157 dias. O suprimento das matérias-primas corresponde a 88% do tempo total, sendo que só a requisição e a aquisição correspondem a 72% do tempo total. A primeira vista, a legislação rígida do serviço público parece ser o maior fator de atraso no sistema produtivo de Farmanguinhos. A lei veda a escolha de fornecedores e contratos de exclusividade por longos períodos a não ser em condições excepcionais. Ficando assim, na contramão das empresas de ponta no mercado privado que montam suas cadeias de suprimentos com empresas de sua escolha e com exclusividade. As propostas para tentar reduzir o tempo de suprimento passam pela qualificação de fornecedores e realização de Registro de Preços para aquisição das matérias-primas
The pharmaceutical production, as well as the manufactured products production, requires raw materials, which initially need an effective planning and then an efficient control to guarantee that the final product will be deliver in the required conditions. Failure to inputs of the acquisition process can result negatively on the entire commodity chain. Farmanguinhos, as Brazilian official pharmaceutical laboratories (LFO), should follow the Brazilian law no. 8666 of June 21, 1993, that treats about acquisition process, which makes the activity more complex and turn planning and production control complex too. Thus, this study objective to analyze Farmanguinhos supply chain system the Farmanguinhos and propose improvements in the planning and control of raw materials. It was conducted a descriptive study, having as a methodological strategy a case study of the Farmanguinhos. Calculations were make between theoretical and actual times for each stage of the antiretroviral production process at the LFO in question. In addition, information’s were show regarding the experiences of other LFO and finally improvement proposals were make. According to customer service, Farmanguinhos has not had good performance, only 24% of requests were delivery on time. Has a total average service time in the years 2010-2014 of 395 actual days against an expectation of the main customer, the Ministry of Health, of 157 days. The raw material supply correspond to 88% of the total time and, if we concentrate only the in request and in acquisition this correspond to 72% of the total time. At first glance, the rigid law of public service seems to be the longest delay factor in the productive system Farmanguinhos. The law prohibits the choice of suppliers and exclusive contracts for long periods unless in exceptional condition. Being against the leading companies in the private market that hires their supply chain with companies of your choice and being exclusive. The proposal try to reduce the leading time passes the qualification of suppliers and price record of accomplishment to purchase materials.
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Bernardo, Naíssa Prévide. "Análise estereosseletiva do cloridrato de cis-tramadol e de suas impurezas em matéria-prima e formulação farmacêutica." Universidade de São Paulo, 2008. http://www.teses.usp.br/teses/disponiveis/60/60134/tde-10122008-222618/.
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O cloridrato de tramadol, analgésico sintético de ação central, possui dois centros quirais: o isômero cis é ativo e o isômero trans é uma impureza de processo. Ambos os enantiômeros do cloridrato de cis-tramadol contribuem para o efeito analgésico, mas através de mecanismos diferentes, complementares e interativos farmacologicamente. Os dois isômeros do cis-tramadol apresentam efeitos terapêuticos, e a presença de impurezas, incluindo os isômeros trans - decorrentes do processo de síntese ou devido à decomposição - podem comprometer a qualidade do produto comercializado. Assim, este trabalho teve como objetivo desenvolver e validar metodologia estereosseletiva para análise do cloridrato de cis-tramadol e das possíveis impurezas quirais ou não na matéria-prima e formulações farmacêuticas. Para a separação e quantificação dos enantiômeros do cloridrato de cis-tramadol e das impurezas trans-tramadol, 1,2-olefina e 1,6-olefina, foi utilizada a coluna Chiralcel® OD-H, fase móvel constituída por hexano (60% e 100% de n-hexano, 1:1, v/v):isopropanol:dietilamina:ácido trifluoracético (99,5:0,5:0,3:0,1, v/v/v/v), na vazão de 0,7 mL min-1 e detecção em 274 nm. A coluna Chiralpak® AD fase móvel constituída por hexano (60% de n-hexano):etanol absoluto:dietilamina (95:5:0,1, v/v/v), na vazão de 1,0 mL min-1 e o comprimento de onda para detecção dos compostos foi de 228 nm foi utilizada para a separação e quantificação das impurezas O-desmetiltramadol, N-desmetiltramadol e tramadol N-óxido. Os métodos desenvolvidos foram devidamente validados através dos parâmetros seletividade, linearidade, precisão, exatidão, intervalo, limite de detecção e limite de quantificação. Os resultados obtidos na validação mostraram que os métodos são adequados para a determinação do cis-tramadol e de suas impurezas na matéria prima e na formulação farmacêutica.Tramadol hydrochloride is a centrally acting analgesic with two chiral centers; the cis isomer is the active drug and the trans isomer is a process impurity. Both enantiomers of cis-tramadol hydrochloride contribute to the analgesic effect through different, but complementary and interactive pharmacological mechanisms. Although both isomers of cis-tramadol hydrochloride show therapeutic effects, the presence of impurities, originated from the synthesis process or due to degradation, can compromise the quality of the marketed product. The aim of this present work was the development and validation of a stereosselective methodology for the analysis of the drug cis-tramadol hydrochloride and the possible chiral or non-chiral impurities in raw materials and pharmaceutical formulations. The separation and quantitation of cis-tramadol enantiomers and the impurities trans-tramadol, 1,2-olefin and 1,6-olefin were carried out using a Chiralcel® OD-H column, mobile phase of hexane (60% and 100% of n-hexane, 1:1, v/v):2-propanol:diethylamine:trifluoroacetic acid (99,5:0,5:0,3:0,1, v/v/v/v) at a flow rate of 0,7 mL min-1 and detection at 274 nm. For the separation and quantitation of the impurities O-desmethyltramadol, N-desmethyltramadol and tramadol N-oxide, a Chiralpak® AD column was used with a mobile phase of hexane (60% of n-hexane):ethanol absolute: diethylamine (95:5:0,1, v/v/v) at a flow rate of 1,0 mL min-1 and detection at 228 nm. The methods were validated using the parameters selectivity, linearity, precision, accuracy, range, detection limit and quantitation limit. The results obtained show that the methods are suitable for the analysis of cis-tramadol and its impurities in raw material and pharmaceutical formulation.
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Botteselle, Giancarlo di Vaccari. "Síntese de 2-aril e 2,5-diarilfuranos funcionalizados: potenciais sondas fluorescentes." Universidade de São Paulo, 2009. http://www.teses.usp.br/teses/disponiveis/9/9138/tde-18092009-153237/.
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A utilização de sondas fluorescentes para marcação ou detecção de biomoléculas de interesse em processos biológicos distintos, vem recebendo grande atenção em pesquisas biomédicas, de análises clínicas e biologia celular. Em geral, estas sondas fluorescentes são constituídas por moléculas orgânicas pequenas, as quais apresentam características fluorescentes e capacidade de conjugar-se com estas biomoléculas. Desta forma, esta dissertação descreve inicialmente a síntese de compostos 2-aril ou 2,5- diarilfuranos e tiofenos (3, 5, 7 e 9a-i), a partir de espécies orgânicas de telúrio (1, 4, 6 e 8) e sais de ariltrifluoroboratos de potássio (2a-i), via reação de acoplamento cruzado tipo Suzuki-Miyaura, sob catálise de paládio [ver a figura no arquivo original]. Em seguida, descreve a síntese de um derivado 2,5-diarilfurano assimétrico, o 2-(3-aminofenil)-5-(4-metoxifenil)furano 11, o qual apresenta propriedades químicas e luminescentes adequadas para atuar como uma nova e promissora sonda fluorescente em processos de marcação ou detecção biológica. A síntese desta nova sonda, também chamada de 3-AFA (3-AnililFuranoAnisol), foi realizada a partir da reação de acoplamento cruzado tipo Suzuki-Miyaura, sob catálise de paládio, entre o ácido (3-aminofenil) borônico 5e e o 2- (butiltelanil)-5-(4-metoxifenil)furano 10 em 65 % de rendimento. Esta nova sonda 3-AFA 11 foi conjugada com uma série de L-aminoácidos 12a-l, a partir de uma reação de acoplamento peptídico para formação dos respectivos produtos 13a-l em rendimentos satisfatórios. Estes produtos conjugados 13a-l, apresentam potencial para marcação fluorescente de enzimas proteolíticas de interesse [ver a figura no arquivo original]. Adicionalmente, foram caracterizadas propriedades fotofísicas importantes desta nova sonda 3-AFA 11, entre as quais seus espectros eletrônicos de absorção e emissão de fluorescência, que obtiveram valores de λex a 320 nm e λem a 400 nm, respectivamente. Por fim, foi testado o potencial de acúmulo intracelular da sonda 3-AFA 11 em sistemas celulares tais como: eritrócitos infectados com Plasmodium chabaudi e amastigotas de Leishmania L. amazonensis, sendo possível observar em todos os casos a marcação fluorescente dos respectivos parasitas.The use of fluorescent probes for labeling or detection of biomolecules of interest in different biological processes, has received much attention in biomedical, clinical testing and cell biology research. In general, these fluorescent probes are composed of small organic molecules, which have fluorescent features and ability to combine with these biomolecules. Thus, this work initially describes the synthesis of 2-aryl or 2,5-diarylfurans and thiophenes (3, 5, 7 and 9a-i) from organic species of tellurium (1, 4, 6 and 8) and potassium organotrifluoroborate salts (2a-i) by palladium catalyzed Suzuki-Miyaura crosscoupling reaction [see the figure in the original file]. After describe the synthesis of a unsymmetrical 2,5-diarylfuran derivative, the 2-(3-aminophenyl)-5-(4-methoxyphenyl)furan 11, which presents chemical and luminescent properties appropriate to act as a promising new fluorescent probes in processes of marking or biological detection. The synthesis of this new probe, also called 3-AFA (3-AnilylFuranAnisole), was performed from palladium catalyzed Suzuki-Miyaura cross-coupling reaction, between (3- aminophenyl) boronic acid 5e and 2-(butyltellanyl)-5-(4-metoxyphenyl)furan 10 in 65 % yields. This new probe 3-AFA 11 was combined with a series of Lamino acids 12a-l from a peptidic coupling reaction to obtain their products 13a-l in satisfactory yield. These combined products 13a-l show a potential for fluorescent marking of proteolitic enzymes [see the figure in the original file]. Additionally, important photo physical properties of this new probe 3-AFA 11 were characterized. These include their electronic spectra of absorption and fluorescence emission, who obtained values of λex to 320 nm and λem to 400 nm, respectively. Finally, we tested the potential of probe 3-AFA 11 for intracellular accumulation in cellular systems such as: erythrocytes infected with Plasmodium chabaudi and amastigotes of Leishmania L. amazonensis, in all cases the fluorescent uptake cellular of their parasites can be observed.
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Mohamadi, Khonaw. "Quantitative NMR spectroscopy on fluorine-containing drugs - a comparative study on pharmaceutical raw materials and different dosage forms." Thesis, Uppsala universitet, Analytisk farmaceutisk kemi, 2020. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-405955.
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Nuclear Magnetic Resonance (NMR) is a technique with several advantages, such as high rapidity and easy operation as no sample specific standard or sample derivatization is required. Proton NMR is the most common NMR experiment, since hydrogen is “NMR active” and present in most organic compounds. Because of this, there is a high risk of overlapping signals in 1H-NMR spectra in samples containing multiple components, e.g. pharmaceutical preparations. Since Fluorine (19F) is “NMR active”, but not as common in organic molecules as hydrogen, peak overlapping is unlikely. A quantitative 19F-NMR method was therefore developed in this study. Certain parameters (number of scans, relaxation delay, excitation frequency, pre-scan delay, spectral width & pulse angle) were examined during the method development, based on samples containing fludrocortisone acetate and 4,4´-difluorobenzophenone. For evaluation of the developed method, experiments were set up with different active pharmaceutical ingredients as well as pharmaceutical products. Good linearity and precision was obtained, and conclusions from the research experiments are that the developed method gives reliable purities compared to the reference method 1H-qNMR, and can therefore be used to achieve estimated assays on pharmaceutical raw materials. The method is also applicable on analysing registered pharmaceutical products as well as determining whether the strength of a suspected illegal drug is within the therapeutic range or not. Finally, the range of the method was determined to approximately 1-20 mg/mL, if examined on a 300 MHz NMR instrument.
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Swanepoel, Erna. "Relation between solid-state properties and pharmaceutical quality of generic drug raw materials available in South Africa / Erna Swanepoel." Thesis, North-West University, 2003. http://hdl.handle.net/10394/365.
Full textAbstract:
Although improving the quality of drugs is a responsibility to be shared, the generic sector
of the pharmaceutical industry, as the source of the majority of essential drugs, must play a
critical role in improving drug quality. One sector often overlooked is raw material
manufacturers and suppliers. The quality of these materials is essential for the safety,
efficacy and quality of drug products. The aim of this study was to investigate the
pharmaceutical quality of generic raw materials available to manufacturers in South
Africa, as well as the influence that variations in the solid-state properties of these raw
materials have on the in vitro availability (dissolution) of these drugs.
In order to save time and cost it is very important to choose the most suitable form of the
crystalline drug substance in the initial stages of drug development. Differences in
physical properties of various solid forms have an important effect on the processing of
drug substances into drug products. Substantial inconsistent and questionable
pharmaceutical quality were found among 135 drugs available on the South African
market. In particular differences in crystal form, solubility and dissolution were seen.
Worldwide regulatory agencies and national and international pharmacopoeias are relying
on the dissolution test, not only for assessment of drug products, but for relevance to in
vivo performance. There is still much to be done to establish dissolution testing as a
harmonized regulatory quality control procedure, although the ICH initiative has moved
significantly towards resolution of regulatory harmonization. Dissolution problems
experienced in this study with specific generic raw materials and drug products, namely
piroxicarn, oxytetracycline and mebendazole, showed that harmonization is urgently
needed. Harmonization of dissolution should however not be done in isolation from other
regulatory requirements, because it was found that accelerated stability testing at 40°C +
75% relative humidity for three months leads to physicochemical changes in
oxytetracycline capsules and that the BP dissolution method was not able to measure the
effect of these changes on the dissolution properties of the capsules.
This study shows that professional judgement must he exercised in the purchase of generic
drug raw materials by manufacturers. Existing techniques such as X-ray analysis, melting
point measurements and especially dissolution testing can be used by manufacturers to
monitor and detect variations in product quality due to changes in the solid-state properties
of drugs.Thesis (Ph.D. (Pharmaceutics))--North-West University, Potchefstroom Campus, 2004.
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Souihi, Nabil. "Multivariate Synergies in Pharmaceutical Roll Compaction : The quality influence of raw materials and process parameters by design of experiments." Doctoral thesis, Umeå universitet, Kemiska institutionen, 2014. http://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-96441.
Full textAbstract:
Roll compaction is a continuous process commonly used in the pharmaceutical industry for dry granulation of moisture and heat sensitive powder blends. It is intended to increase bulk density and improve flowability. Roll compaction is a complex process that depends on many factors, such as feed powder properties, processing conditions and system layout. Some of the variability in the process remains unexplained. Accordingly, modeling tools are needed to understand the properties and the interrelations between raw materials, process parameters and the quality of the product. It is important to look at the whole manufacturing chain from raw materials to tablet properties. The main objective of this thesis was to investigate the impact of raw materials, process parameters and system design variations on the quality of intermediate and final roll compaction products, as well as their interrelations. In order to do so, we have conducted a series of systematic experimental studies and utilized chemometric tools, such as design of experiments, latent variable models (i.e. PCA, OPLS and O2PLS) as well as mechanistic models based on the rolling theory of granular solids developed by Johanson (1965). More specifically, we have developed a modeling approach to elucidate the influence of different brittle filler qualities of mannitol and dicalcium phosphate and their physical properties (i.e. flowability, particle size and compactability) on intermediate and final product quality. This approach allows the possibility of introducing new fillers without additional experiments, provided that they are within the previously mapped design space. Additionally, this approach is generic and could be extended beyond fillers. Furthermore, in contrast to many other materials, the results revealed that some qualities of the investigated fillers demonstrated improved compactability following roll compaction. In one study, we identified the design space for a roll compaction process using a risk-based approach. The influence of process parameters (i.e. roll force, roll speed, roll gap and milling screen size) on different ribbon, granule and tablet properties was evaluated. In another study, we demonstrated the significant added value of the combination of near-infrared chemical imaging, texture analysis and multivariate methods in the quality assessment of the intermediate and final roll compaction products. Finally, we have also studied the roll compaction of an intermediate drug load formulation at different scales and using roll compactors with different feed screw mechanisms (i.e. horizontal and vertical). The horizontal feed screw roll compactor was also equipped with an instrumented roll technology allowing the measurement of normal stress on ribbon. Ribbon porosity was primarily found to be a function of normal stress, exhibiting a quadratic relationship. A similar quadratic relationship was also observed between roll force and ribbon porosity of the vertically fed roll compactor. A combination of design of experiments, latent variable and mechanistic models led to a better understanding of the critical process parameters and showed that scale up/transfer between equipment is feasible.
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Wheeler, Jake T. "The effects of vendor and quality control variability in the procurement of raw materials in a bio-pharmaceutical company." Thesis, Massachusetts Institute of Technology, 2011. http://hdl.handle.net/1721.1/68901.
Full textAbstract:
Thesis (M. Eng. in Logistics)--Massachusetts Institute of Technology, Engineering Systems Division, 2011.Cataloged from PDF version of thesis.
Includes bibliographical references (p. 65-66).
Pharmaceutical companies have traditionally placed little emphasis on supply chain efficiencies and operations costs. With the changing landscape of expiring intellectual property rights and increased market segmentation, the need for improved supplier relations and inventory management is becoming paramount. This thesis presents a study of a procurement system within a biopharmaceutical company. The many sources of variation in delivery lead times from both suppliers and internal departments coupled with variation in manufacturing demand, has resulted in excess raw-material inventory at the company. By using discrete-events-simulation software to model the system and its inputs, we generate insights that can help the materials management team maximize their efforts to improve the system performance. In this particular case, it was found that reducing supplier lead time variability was far more effective in reducing the need for inventory than reducing average lead times or even internal lead times from the Quality Control department. The pharmaceutical company involved in this study would be best served by focusing its efforts on working with suppliers to increase the consistency of delivery for their raw materials. This increased consistency will allow them to reduce total inventory costs by reducing the variability of the raw-material supplies.
by Jake T. Wheeler.
M.Eng.in Logistics
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Mahlin, Denny. "Phase Transformations in Solid Pharmaceutical Materials Studied by AFM, ESCA, DSC and SAXS." Doctoral thesis, Uppsala : Acta Universitatis Upsaliensis, 2004. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-4575.
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Mavumengwana, Bongeka Nomakhephu. "The evaluation of a handheld Raman Analyser for the good laboratory practise (glp) compliant identification of paracetamol raw materials, in a pharmaceutical manufacturing environment." Thesis, Nelson Mandela Metropolitan University, 2015. http://hdl.handle.net/10948/4243.
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The use of a handheld Raman analyser for the positive identification of raw materials in a manufacturing pharmaceutical company was evaluated using paracetamol as test raw material to evaluate whether such a system would meet Aspen’s regulatory requirements. The approach involved subjecting the chosen raw material to identification tests under a variety of conditions so as to evaluate robustness, and specificity of the system. Thus, raw material provided by different suppliers, different packages of one manufacturing batch, and raw materials subjected to different storage conditions were evaluated. Specificity was evaluated by deliberately contaminating a sample of paracetamol with either acetanilide, or 4-aminophenol, or both at varying concentration levels. The results obtained from these investigations showed that the handheld Raman analyser can correctly identify the selected raw material (paracetamol) under a wide range of conditions, but could not correctly identify the presence of the selected contaminants at lower concentration levels (< 10 – 20 mass percent). Finally, a cost-benefit analysis was carried out in which a scenario of an existing FTIR-ATR system is used for the analysis of a specific number of raw material samples per year as opposed to a scenario in which a new handheld Raman analyser has to be purchased, set up, and used for the analysis of the same number of raw material samples. This comparison showed that the handheld Raman analyser had a pay-back time of approximately 6 months and gave a return on investment of approximately the same value as the actual purchase cost.
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Almeida, Elizabeth Nimrichter de. "Análise do trabalho de qualificação de fornecedores de insumos farmacêuticos da Unidade Farmanguinhos." reponame:Repositório Institucional da FIOCRUZ, 2009. https://www.arca.fiocruz.br/handle/icict/2515.
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Previous issue date: 2009Considerando a estreita relação entre a lógica econômica e as necessidades da área de saúde, o estudo em questão interliga o trabalho de Qualificação de Fornecedores de Insumos Farmacêuticos com o desempenho produtivo das Indústrias Farmacêuticas no contexto do Complexo Industrial da Saúde. Como objetivo evidencia o inter-relacionamento de ordem administrativa, técnica e operacional, frente o desempenho articulado entre os Procedimentos internos adotados por Farmanguinhos, seus processos de Aquisição, Validação, Manufatura e Inovação de Medicamentos, e a Qualidade e Especificidade dos Insumos Farmacêuticos adquiridos, demonstrando dentro desta ambiência, o impacto promovido pelo Trabalho de Qualificação de Fornecedores, em conformidade com os requisitos de qualidade visando às Boas Práticas de Fabricação. Como referencial teórico e regulatório, fundamenta além do contexto econômico, político e institucional capitalista associado à produção de bens e serviços do Complexo Industrial da Saúde, a representatividade da Indústria Farmacêutica frente à balança comercial nacional e desenvolvimento econômico, a conexão de conformidades entre os trabalhos de Validação e as Boas Práticas de Fabricação, bem como a interdependência entre a especificidade dos insumos farmacêuticos, seus processos de aquisição pelo setor público e os trabalhos de qualificação de fornecedores, tudo no âmbito da cadeia de produção de medicamentos. O impacto destes fundamentos frente à dinâmica administrativa, técnica e operacional produtiva de Farmanguinhos é evidenciado por informações oriundas de pesquisa exploratória, documental e de campo, empregada na metodologia de intervenção. Na análise de campo foram evidenciados procedimentos adotados por Farmanguinhos, relacionados com a aquisição pela administração pública e com a qualificação de fornecedores de insumos farmacêuticos, apresentando diagnóstico dos índices de reprovações das matérias-primas e medicamentos manufaturados e sua repercussão frente à demanda programada pelo Ministério da Saúde. Integrada à meta de excelência operacional de Farmanguinhos, a proposta identifica na Qualificação de Fornecedores, apoiada pelos trabalhos de Validação e Aquisições, estabilidade nos processos de inovação e manufatura, fortalecendo estratégias industriais e atendimento as demandas do Sistema Único de Saúde.
Considering the relation between the economic logic and the necessities of the health area, the study in subject establishes connection the Raw Pharmaceutical Suppliers Qualification’s Work with the productive performance of the Pharmaceutical Industries in the context of the Health Industrial Complex. As objective it evidences the Inter-relationship of administrative, operational and technique orders, front of the articulated performance of the internal Procedures adopted by Farmanguinhos, its processes of Acquisition, Validation, Manufacture and Innovation of Medicines, and the Quality Specified Raw Pharmaceutical acquired, demonstrating inside of this environment, the impact promoted for the Suppliers Qualification’s Work, in compliance with the Good Manufacturing Practices quality requirements. As regulatory and theoretician referential, it bases beyond the economic, politician and institutional capitalist context associated with the production of goods and services of the Health Industrial Complex, the representation of the Pharmaceutical Industry front to the national trade balance and economic development, the connection of conformity between the Validation’s work and the Good Manufacturing Practices, as well as the interdependence enters the specificity of the Raw Pharmaceutical, its public acquisition processes and the supplier qualification works, everything in the scope of the chain of medicine production. The impact of these bases front to the Farmanguinhos administrative, productive and operational technique dynamics is evidenced by deriving information of exploratory research, documentary and of field, used in the intervention methodology. In the field analysis procedures adopted for Farmanguinhos had been evidenced, related with the acquisition for the public administration and with the Raw Pharmaceutical Suppliers Qualification’s Work presenting diagnostics of the raw materials and manufactured medicines disapprove index and its repercussion front to the demand programmed for the Health Ministry. Integrated to the goal of Farmanguinhos operational excellency, the proposal identifies in the Suppliers Qualification, supported for the works of Validation and Acquisitions, stability in the innovation processes and manufactures, fortifying industrial strategies and attendance the demands of the Health System.
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Oreland, Sadia. "Maternal Separation in the Rat : The Short- and Long-term effects of Early-life Experience on Neuropeptides, Monoamines and Voluntary Ethanol Consumption." Doctoral thesis, Uppsala universitet, Institutionen för farmaceutisk biovetenskap, 2009. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-108678.
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Early-life experience has profound effects on the individual’s neurobiology and behaviour later in life. The rodent animal experimental model maternal separation (MS) was used to study this more in detail. The MS model involves short and prolonged postnatal separations simulating an emotionally safe and stressful environment, respectively. The aims of the thesis were to examine the impact of individual MS on ethanol consumption and on brain dopamine and serotonin systems in adult male rats. Furthermore, the influence of separation conditions on the short- and long-term consequences of MS on several neurotransmitter systems was examined. Rat pups were assigned to either litter-wise MS for 15 or 360 minutes (MS15l or MS360l) or individual MS for 15 or 360 minutes (MS15i or MS360i). Control rats were subjected to conventional animal facility rearing (AFR). Ethanol intake was assessed in a two-bottle free-choice paradigm. Neuropeptides were analyzed with radioimmunoassay, monoamines and metabolites with electrochemical detection and gene expression with qPCR. Using the MSi paradigm, minor effects on voluntary ethanol consumption were observed. However, the monoaminergic responses elicited by ethanol were dependent on the early-life environment. Furthermore, short- and long-term consequences of MS on serotonin, opioid, oxytocin and vasopressin systems were studied. Multiple neurobiological measurements in one and the same rat offered a unique possibility to examine the effects of duration (MS15 versus MS360) and condition (l versus i) of MS. Time-, region-, sex- and transmitter-specific effects were observed. More pronounced differences were seen in serotonin measures and oxytocin in young rats. In adults these differences in basal levels were normalized. Opioid peptides differed in stress-related brain areas in young rats and in limbic areas in adults. Rats subjected to the MS15l environment that relates to natural conditions generally exhibited a different neurobiological profile than other groups. AFR rats, i.e. conventional control rats, were more similar to the putative most stressful condition MS360. Taken together, the networks examined in the present thesis are important for the establishment of normal social behaviour and derangements in these systems may result in neurobiological changes leading to the susceptibility for psychopathological conditions later in life.
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Real, Robson dos Santos. "Otimização do programa de qualificação de fornecedores de Farmanguinhos utilizando um sistema de gestão de informações." reponame:Repositório Institucional da FIOCRUZ, 2012. https://www.arca.fiocruz.br/handle/icict/11671.
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Previous issue date: 2012Fundação Oswaldo Cruz. Instituto de Tecnologia em Fármacos/Farmanguinhos. Rio de Janeiro, RJ, Brasil.
O Programa de Qualificação de Fornecedores (PQF) é de suma importância para empresas, sobretudo para as indústrias farmacêuticas. Segundo a RDC17/2010, que regula as Boas Práticas de Fabricação de medicamentos na indústria farmacêutica, este é um requisito indispensável e visa garantir a aquisição de insumos farmacêuticos com a qualidade requerida para serem utilizados na fabricação de produtos. Em uma indústria farmacêutica, que possui um PQF, o resultado pode ser observado em diversas etapas do processo produtivo:otimização do espaço no almoxarifado, número menor de amostragens e análises do controle de qualidade, menor número de reprovações e devoluções de insumos farmacêuticos, menos atrasos no processo produtivo, diminuição do número de reprocessos e não-conformidades em lotes produzidos. A falta de um efetivo PQF trouxe consequências negativas para Farmanguinhos, no período 2008/2009 aproximadamente 9,3% dos insumos farmacêuticos adquiridos apresentaram algum desvio de qualidade, mas foram aprovados com restrição; e 33% foram reprovados. Logo, a determinação de responsabilidades dos setores envolvidos, a criação de um fluxo de informações, a adequação do sistema de gestão de informações (SGI)bem como o cadastro dos fornecedores, e o monitoramento de seus insumos (qualidade, prazo de entrega e quantidades) são de extrema importância no desenvolvimento de um PQF. É neste sentido que o presente trabalho foi desenvolvido, na proposição de otimização do PQF de Farmanguinhos integrando diversos setores e determinando suas respectivas responsabilidades neste programa utilizando um SGI, permitindo o monitoramento e gerenciamento dos fornecedores e seus respectivos insumos farmacêuticos desde o momento do recebimento até sua utilização no processo produtivo.
The Supplier Qualification Program (SQP) is of great importance for the companies, mainly in case of pharmaceutical industries. According to RDC 17/2010, which is the statement of Good Manufacturing Practices in Brazil, SQP is classified as an essential item to ensure the acquisition of raw materials with the required quality for using drug products. In a pharmaceutical company, the beneficts of a SQP successful implemented can be observed in different stages of the manufacturing flow: optimization of warehouse space, reduced sampling and Quality Control analyses, lower number of raw materials rejections and reprocesses and deviation on batches products. The absence of an effective SQP brought negative consequences for Farmanguinhos in the period 2008/2009. Approximately 9.3% raw materials had some quality deviation and were approved with restriction. Around 33% was rejected. So, the determination of responsibilities for the involved areas, the creation of an information flow as well of a suppliers database, the monitoring of the raw materials (quality, quantities and time delivered) and the adequation of Information Management System (IMS) is of quite relevance in the development and implementation of a SQP. In this way, the present work has been developed with the proposal of improving SQP-Far which can integrate different departments and determine their respective responsibilities in this program using an IMS, enabling monitoring and management process of suppliers and their respective raw materials since the reception until utilization in the productive process.
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Elbagerma, Mohamed A. "Analytical method development for structural studies of pharmaceutical and related materials in solution and solid state : an investigation of the solid forms and mechanisms of formation of cocrystal systems using vibrational spectroscopic and X-ray diffraction techniques." Thesis, University of Bradford, 2010. http://hdl.handle.net/10454/4467.
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Analysis of the molecular speciation of organic compounds in solution is essential for the understanding of ionic complexation. The Raman spectroscopic technique was chosen for this purpose because it allows the identification of compounds in different states and it can give information about the molecular geometry from the analysis of the vibrational spectra. In this research the ionisation steps of relevant pharmaceutical material have been studied by means of potentiometry coupled with Raman spectroscopy; the protonation and deprotonation behaviour of the molecules were studied in different pH regions. The abundance of the different species in the Raman spectra of aqueous salicylic acid, paracetamol, citric acid and salicylaldoxime have been identified, characterised and confirmed by numerical treatment of the observed spectral data using a multiwavelength curve-fitting program. The non-destructive nature of the Raman spectroscopic technique and the success of the application of the multiwavelength curve-fitting program demonstrated in this work have offered a new dimension for the rapid identification and characterisation of pharmaceuticals in solution and have indicated the direction of further research. The work also covers the formation of novel cocrystal systems with pharmaceutically relevant materials. The existence of new cocrystals of salicylic acid-nicotinic acid, DLphenylalanine , 6-hydroxynicotinic acid, and 3,4-dihydroxybenzoic acid with oxalic acid have been identified from stoichiometric mixtures using combined techniques of Raman spectroscopy (dispersive and transmission TRS), X-ray powder diffraction and thermal analysis. Raman spectroscopy has been used to demonstrate a number of important aspects regarding the nature of the molecular interactions in the cocrystal. Cocrystals of salicylic acid - benzamide, citric acid-paracetamol and citric acid -benzamide have been identified with similar analytical approaches and structurally characterised in detail with single crystal X-ray diffraction. From these studies the high selectivity and direct micro sampling of Raman spectroscopy make it possible to identify spectral contributions from each chemical constituent by a peak wavenumber comparison of single-component spectra (API and guest individually) and the two- component sample material (API/guest), thus allowing a direct assessment of cocrystal formation to be made. Correlation of information from Raman spectra have been made to the X-ray diffraction and thermal analysis results. Transmission Raman Spectroscopy has been applied to the study cocrystals for the first time. Identification of new phases of analysis of the low wavenumber Raman bands is demonstrated to be a key advantage of the TRS technique.
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CHANG, FEI-JU, and 張斐如. "The influences of Customer Product Knowledge、Brand acknowledgment and Brand Image with respect to Pharmaceutical raw material purchasing propensity." Thesis, 2019. http://ndltd.ncl.edu.tw/handle/2x6ee4.
Full textAbstract:
碩士南臺科技大學
行銷與流通管理系
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As the population structure of every country has begun to turn into the aging generation, and the global environmental deterioration trend has made the people to create new research breakthroughs to fight against various kinds of diseases. Therefore, the biotechnology and the medical industry have become flourished. Due to the growth of supply and demand in the market, the generic pharmaceutical companies in various countries have been increasing the requirement of raw materials significantly. In particular , the governments of various countries actively encourage the domestic generic pharmaceutical companies to increase penetration to reduce medical expenses, so that the generic pharmaceutical companies will not be limited to patent raw materials and have more flexible to choose the raw materials they need. When the generic pharmaceutical companies enter the market and compete continuously, the choice of purchasing raw materials increases and the purchase behavior pattern will be changed. The brands of the raw material that the traders supply for the generic pharmaceutical companies have changed from singularity to variety. Consequently, to the generic pharmaceutical companies, the knowledge of the raw material products and the cognition of raw material brands are becoming more important than before. The brand image of the raw material traders will also be considered as an indicator of evaluation, and the purchase intention of customers would also be affected. This study mainly focuses on " The influences of Customer Product Knowledge、Brand acknowledgment and Brand Image with respect to Pharmaceutical raw material purchasing propensity " to study its relationship and explore the elements of formation of product knowledge, brand awareness, brand image, and purchase intention, providing company with the proposal to formulate relevant sales strategies, so that the company can enhance its competitiveness in the raw material sales market through this research, and also meet customers’ demand for quality and price, thereby enhance the company's profit for sustainable operation. A questionnaire survey was conducted to collect and analyze the verification data, 330 valid questionnaires were collected and analyzed by SPSS 24 statistical software in total. The empirical results of this study are as follows: product knowledge will significantly affect brand image, brand cognition and purchase intention with direct proportion. Brand image will notably influence the purchase intention and brand cognition with direct ratio. Brand cognition will affect the purchase intention and have a remarkable positive relationship.
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Rocha, Verónica Patrícia Moreira da. "Study of the cytotoxicity of raw materials of cosmetic and topical pharmaceutical formulations." Dissertação, 2015. https://repositorio-aberto.up.pt/handle/10216/82502.
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Rocha, Verónica Patrícia Moreira da. "Study of the cytotoxicity of raw materials of cosmetic and topical pharmaceutical formulations." Master's thesis, 2015. https://repositorio-aberto.up.pt/handle/10216/82502.
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Maciel, Bruna Catarina de Freitas. "Implementation and validation of in vitro methodologies for phototoxicity evaluation of raw materials of pharmaceutical and cosmetic products." Dissertação, 2016. https://repositorio-aberto.up.pt/handle/10216/87815.
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Maciel, Bruna Catarina de Freitas. "Implementation and validation of in vitro methodologies for phototoxicity evaluation of raw materials of pharmaceutical and cosmetic products." Master's thesis, 2016. https://repositorio-aberto.up.pt/handle/10216/87815.
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Canelas, Ana Rita de Paiva. "Dosing the active ingredient in pharmaceutical powder mixtures using near-infrared spectroscopy (NIRS)." Master's thesis, 2014. http://hdl.handle.net/10451/17843.
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Tese de mestrado, Engenharia Farmacêutica, Universidade de Lisboa, Faculdade de Farmácia, 2014O primeiro objectivo desta tese foi o desenvolvimento de um método de quantificação por espectroscopia de infravermelho próximo de modo a optimizar um processo de fabrico da OM Pharma numa fase crítica de produção: fase final da mistura. Em seguida avaliou-se a aplicabilidade do mesmo tipo de estratégia ao controlo (identificação, qualificação e quantificação) de outros pontos críticos do processo. A necessidade da implementação desta metodologia incide no facto de a este processo estar associado um volume de trabalho significativo de trabalho do Controlo de Qualidade. O modelo de quantificação desenvolvido permite a determinação do parâmetro de qualidade crítico do processo de fabrico do produto: a conformidade do teor em API na mistura; após a verificação da conformidade processo produtivo evolui para outra fase – produto final. A aplicação desta técnica desenvolvida permite, em rotina, a redução do tempo despendido em análise pelo Controlo de Qualidade. O modelo obtido foi validado de acordo com as Guidelines em vigor. Um segundo objectivo, foi o de generalizar a aprendizagem anterior e desenvolver uma biblioteca para diversas matérias-primas (princípios activos farmacêuticos) que permitisse a sua identificação e no futuro possivelmente a sua qualificação; esta necessidade surge devido à elevada quantidade de lotes de matériaprima recepcionada periodicamente na OM Pharma. A criação da biblioteca consiste no desenvolvimento de um método que permita identificar o princípio activo referido no modelo de quantificação, o que acarreta a construção de uma Biblioteca de Princípios Activos (API) obtida pela aquisição de espectros NIR de todos os API´s da OM Pharma. A biblioteca desenvolvida foi sujeita a validação interna e externa de acordo com os requisitos das Guidelines em vigor. Concluiu-se que a espectroscopia de infravermelho próximo é um método preciso e benéfico para a análise e controlo de qualidade no controlo da fase final de produção e na identificação de matérias-primas na Indústria Farmacêutica. Associada à utilização desta técnica, o aumento da produtividade através da redução do tempo de análise e, consequentemente, a redução dos custos operativos é sem dúvida um factor muito positivo.
The first goal of this thesis was the development of a near infrared quantification method in order to optimize the mixing process in OM Pharma’s production phase, followed by the application of this method in controlling other critical processes such as identification, qualification and quantification. The fact that this process is associated with a significant part in Quality Control’s work volume justified the implementation of this methodology. The developed quantification PLS model allows the determination of a product manufacturing process critical quality parameter: the compliance of the API content; after checking this production phase conformity, the process evolves into another phase - final product. The application of this technique allows the reduction of the spent time on routine analysis. The model was validated according to the guidelines. A second goal consisted in developing a library allowing to identify several raw materials (pharmaceutical active ingredients) and in the future it’s possible qualification. This need arose due to the high amount of raw material batches periodically received in OM Pharma. The library development is based on a method developed for identification of the active principle in said quantization model which leads to the construction of a library of active ingredients (API) obtained by the acquisition of NIR spectrum. The developed library was subjected to internal and external validation according to the requirements of the Guidelines in effect. The near infrared spectroscopy method proved itself as an accurate and beneficial method for the analysis and quality control in controlling the final stages of production and raw materials identification in the pharmaceutical industry. Associated to the use of this technique, increased productivity by reducing the analysis time and, consequently, the reduction of operating costs is without a doubt very positive.