Thesis (M. Sc.)--University of Hong Kong, 1998. / Includes bibliographical references (leaf 107-110).

Thesis (M.S.)--Rochester Institute of Technology, 1991. / Typescript. Includes bibliographical references (leaves 54-56).

Thesis (M.S.)--Michigan State University. Packaging, 2008. / Title from PDF t.p. (Proquest, viewed on Aug. 11, 2009) Includes bibliographical references.

In most hospitals today, plastic devices are replacing the traditional metal, glass and rubber. The increased use of polymeric materials as implanted prosthetic devices, catheters, disposable equipment and for the administration of blood, intravenous fluids and drugs has been widely accepted by the medical profession. This present study was designed to evaluate different types of plastics for potential use as large volume parenteral containers. Using several different therapeutic agents, a variety of plastic containers were examined for the possibility of the occurrence of drug-plastic interactions. The inclusion in the study of a commercially available plasticized product used for the administration of parenteral solutions was to compare the results of commercial products to non-commercial products.

published_or_final_version / Environmental Management / Master / Master of Science in Environmental Management

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior / The administration of medication and nutrients via parenteral is very used nowadays. One of the risks of this procedure is the presence of contaminants, which depending on their nature may cause severe damage to the patients due to the direct way of the administration (in the circulatory stream). In this work we investigated the possibility of the containers to be sources of metals for solutions of parenteral nutrition. The investigated containers are made of different kinds of glass and plastic polymers, namely polypropylene, PVC and EVA. The system container/solution (amino acids, salts, glucose and lipids) individually stored, was submitted to the sterilization process and after that stored for a time period of approximately 10 months, since the shelf-life period of these formulations are generally 2 years. After the sterilization and at regular time intervals, aliquots of each solution were collected and their contents on Al, Pb, Cd, Fe, Cr, Mn, Ba, and Zn were measured by graphite furnace atomic absorption spectrometry. The containers were also analyzed for the determination of the amount of each metal they contained. These metals are either constituents of the container material, as Al in glasses, or impurities in the case of plastic polymers. All containers presented the metals investigated. The solutions, depending on their composition (species dissolved) were able to extract the metals either from the glass or the polymers. The highest extraction rates occurred in solutions of the amino acids cysteine and glutamic acid, and in solutions of NaHCO3. The metals released in higher concentration were Ba, Pb and Zn form plastic containers and Al, Pb and Zn form glass containers. A different behavior was observed among the plastic polymers, and the different kinds of glass. While EVA was the most inert polymer, the clear glass ampoule released the highest amount of metals into the solutions. Fifty commercial samples were analyzed as well, and the investigated metals were found in all of them. The commercial formulations presented the same tendency of the individual sample used in the study, either in relation to the behavior of the substance in solution or the container material. / Atualmente a administração parenteral, tanto de medicamentos quanto nutrientes, é uma prática muito difundida. Um dos riscos desta prática é a presença de contaminantes que, dependendo da sua natureza, podem acarretar graves danos aos pacientes devido à forma direta (na corrente circulatória) da administração. Neste trabalho, investigou-se a possibilidade das embalagens serem fontes de contaminação por metais de soluções utilizadas na nutrição parenteral. As embalagens investigadas incluíram vários tipos de vidro e polímeros plásticos mais comumente utilizados (polipropileno, polivinil cloreto (PVC) e etil vinil acetato(EVA)). As embalagens, nas quais foram armazenados individualmente os constituintes das soluções parenterais (aminoácidos, sais, glicose, vitaminas e lipídeos), foram submetidas ao processo de esterilização e de armazenagem a longo prazo, visto que a validade deste tipo de formulação é geralmente de 2 anos. Após a esterilização e em intervalos de tempo regulares, alíquotas das soluções foram retiradas e os teores em Al, Pb, Cd, Fe, Cr, Mn, Ba e Zn foram medidos por espectrometria de absorção atômica forno de grafite (GF AAS) e espectrometria de massa com plasma indutivamente acoplado (ICP-MS). As embalagens utilizadas foram também analisadas para determinar quanto dos metais em estudo elas apresentavam, seja como constituinte, como é o caso do Al no vidro, ou como impureza, no caso de todos os metais nos polímeros plásticos. Todas as embalagens continham os metais em estudo em maior ou menor concentração. As soluções, dependendo dos seus constituintes foram capazes de extrair os metais, tanto do vidro quanto do plástico. As maiores taxas de extração ocorreram com as soluções dos aminoácidos cisteína e acido glutâmico. Os metais extraídos em maiores quantidades foram Ba, Pb e Zn das embalagens plásticas e Al, Pb e Zn das embalagens de vidro. Observou-se diferente comportamento entre os diferentes polímeros e tipos de vidro. O EVA mostrou-se o polímero mais inerte, enquanto que as ampolas transparentes foram as que mais metais liberaram para as soluções. Foram analisadas, também, 50 amostras comerciais, as quais se mostraram contaminadas pelos metais em estudo. Observou-se nas soluções comerciais a mesma tendência das soluções individuais do estudo, tanto com relação ao comportamento da embalagem, quanto ao conteúdo (ação do componente sobre a embalagem) e os metais extraídos.