RESUMO Cateteres centrais de inserção periférica (CCIP) são amplamente utilizados em neonatos internados em Unidades de Terapia Intensiva Neonatal (UTIN). O objetivo do presente estudo foi avaliar as características físicas de CCIP, por meio da aplicação das normas ABNT NBR ISO 10555-1: 2003 e ABNT NBR ISO 10555-3: 2003, e comparar os resultados produzidos na análise de CCIP no início de seu processo de produção (somente catéteres extrusados) com os obtidos na análise do produto acabado. Testes experimentais foram realizados em CCIP fabricados por um fabricante nacional entre os anos de 2011 e 2012. Os dados foram coletados a partir de testes realizados em ambos os catéteres que foram apenas extrusados, ou seja, sem pintar as demarcações, cortes e outros processos relacionados com garantia de qualidade, e catéteres após a conclusão do processo geral de fabricação. No presente estudo, incluiram-se todos os estágios do processo de produção do catéter que podem gerar algum tipo de modificação no produto que poderia gerar riscos aos pacientes que necessitam utilizá-los. Os catéteres foram analisados quanto à resistência à ruptura, radiopacidade, características de fluxo, vazamento de fluido sob pressão e ocorrência de vazamento de ar na montagem do tubo de sucção, conforme preconizado pelas normas NBR ISO 10555-1: 2003 e NBR ISO 10555-3: 2003. Os resultados obtidos foram satisfatórios em todas as análises realizadas, com exceção da resistência à ruptura, que não atendeu às especificações preconizadas pelos padrões para catéteres de silicone. Examinaram-se também catéteres feitos de poliuretano, que por sua vez cumpriram os padrões no que diz respeito à resistência à ruptura. Como as normas não especificam pontos importantes a serem levados em conta para a realização detestes inequivocamente, foram feitas sugestões para a revisão dessas normas.

ABSTRACT Peripherally-inserted central catheters (PICC) are widely used in neonates hospitalized in Neonatal Intensive Care Units (NICU). The aim of the study entertained herein was to evaluate the physical characteristics of PICC, through application of the standards ABNT NBR ISO 10555-1:2003 and ABNT NBR ISO 10555-3:2003, and compare the results produced in the analysis of PICC at the beginning of their production process (extruded catheters only) with those obtained in the analysis of the finished product. Experimental tests were performed in PICC manufactured by a domestic manufacturer between the years 2011 and 2012. The data was gathered from tests performed on both catheters that were just extruded, i.e. without painting the demarcations, cutting and other processes related with quality assurance, and on catheters after completion of the overall manufacturing process. In the present study, one included all stages of the catheter production process that can generate some type of modification in the product that could impart risks to the patients needing to use them. The catheters were analyzed for strength to rupture, radiopacity, flow characteristics, leakage of fluid under pressure, and occurrence of air leak in the suction tube assembly, as advocated by the NBR ISO 10555-1:2003 and NBR ISO 10555-3:2003 standards. The results obtained were satisfactory in all analysesperformed, except for the resistance to rupture, which did not meet the specifications advocated by the standards for catheters made of silicone. One has also examined catheters made of polyurethane, which in turn did meet the standards with regard to resistance to rupture. As standards do not specify important points to be taken into account for conducting tests unequivocally, suggestions were made for revision of those standards.

ABSTRACT Zidovudine (AZT) mucoadhesive solid dispersions (SD) were prepared using a sodium starch glycolate (SSG) and hypromellose phthalate (HPMCP) mixtures as carrier to enhance the intestinal permeability and bioavailability of zidovudine. SDs were prepared using the co-precipitation method followed by solvent evaporation and characterized according to their physicochemical properties such as particle size, crystallinity, thermal behavior, and liquid uptake ability. In vitro drug dissolution, mucoadhesiveness and AZT intestinal permeability were also determined. Thermal behavior and X-ray diffraction patterns demonstrated the amorphous state of AZT in SD systems. The HPMCP polymer restricted the liquid uptake ability in the acid medium; however, this property significantly increased with higher pH values. SDs allowed drug dissolution to occur in a controlled manner. HPMCP decreased the dissolution rates in the acid medium. The mucoadhesiveness of SDs was demonstrated and the permeability of AZT carried in solid dispersions was significantly improved. The effect of the SD carrier polymers on blocking efflux pump can be an important approach to improve the bioavailability of AZT.

A bupropiona é um antidepressivo utilizado no tratamento do tabagismo. O objetivo deste trabalho foi a preparação de filmes hidrogelatinosos de liberação controlada para administração bucal de bupropiona. Os filmes foram preparados utilizando carboximetilcelulose sódica ultrapurificada, hidroxipropilmetilcelulose K4M e quitosana de média viscosidade. As características físico-químicas dos filmes foram avaliadas por microscopia eletrônica de varredura, teor de bupropiona, resistência mecânica (perfuração, relaxação, resiliência e tração) e citotoxicidade. Os resultados mostraram que os filmes em bicamada apresentaram teor de bupropiona de 121 mg por 9 cm2 de filme e que a bupropiona modifica a resistência mecânica dos filmes, sem, no entanto, inviabilizar o uso desta forma farmacêutica. Os estudos de citotoxicidade mostraram que as formulações dos filmes contendo bupropiona não causam dano celular. Este estudo mostrou que a bupropiona veiculada na forma de filme hidrogelatinoso pode ser uma alternativa útil no tratamento do tabagismo.

Bupropion is an antidepressant used in the treatment of smoking. The purpose of this study was to prepare controlled-release hydrogel films for buccal administration of bupropion and investigate its physicochemical and cytotoxic properties. The films were prepared from ultrapure sodium carboxymethylcellulose, hydroxypropylmethylcellulose K4M, and medium-viscosity chitosan. Evaluation of film physicochemical characteristics was based on scanning electron microscopy, bupropion content, mechanical strength (burst strength, relaxation, resilience, and traction), and cytotoxicity. Bupropion content in bilayer films was 121 mg per 9 cm2. The presence of bupropion modified film mechanical strength, but did not compromise the use of this pharmaceutical form. As shown by the cytotoxicity results, films containing bupropion did not cause cellular damage. Bupropion administration in the form of hydrogel films is a potentially useful alternative in the treatment of smoking.

This paper describes a project, construction and test of a low cost air pycnometer, developed to be used preferentially in pharmaceutical research. A complete discussion of the construction, test and calibration of this equipment is presented and some measurements are made using pharmaceutical powders and dry granulations. The equipment performance has been estimated through its calibration curve, and the obtained value to its volume resolution is about 1%. This equipment is accomplished at the Applied Nuclear Physics Laboratory of University of Sorocaba (LAFINAU) in Sorocaba, SP, Brazil and it was denominated "Picnômetro a Ar Uniso - PICNAU".