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1.
Chinese Journal of Medical Instrumentation ; (6): 332-336, 2023.
Article in Chinese | WPRIM | ID: wpr-982240

ABSTRACT

Products made from allogeneic tissue are largely used in clinical treatment due to its wide source compared with autologous tissue, causing less secondary trauma of patients and the good biocompatibility. Various organic solvents and other substances introduced in the production process of allogeneic products will leach down into the human through clinical treatment, thus bringing varying degrees of harm to patients. Therefore, it is very necessary to detect and control the leachables in such products. Based on the classification and summary of leachable substances existing in the allogeneic products, the preparation of extract and the establishment of the detection techniques for known and unknown leachable are briefly introduced in this study, in order to provide research method for the study of leachable substances of allogeneic products.


Subject(s)
Humans , Hematopoietic Stem Cell Transplantation , Drug Packaging
2.
Acta sci., Health sci ; 44: e54648, Jan. 14, 2022.
Article in English | LILACS | ID: biblio-1363590

ABSTRACT

Healthcare services must be guided by biosafety practices and microbial control. This control is highly influenced by humidity, which directly impacts the maintenance of sterility of the materials used in the appointments. High concentration of moisture, in the form of aerosol, splashes and spills, is caused during dental care. During the COVID-19 times the contamination by aerosol and droplets worries greatly. Considering that it could cause harm to the sterility of an autoclaved material, especially in dental environments, the objective was to evaluate the behavior of SMS sterilization packages (Spunbonded / Meltblown / Spunbonded) against microbial penetration in an aqueous vehicle. SMS of three brands were challenged, equally divided into two groups: virgin and processed (subjected to a single autoclaving cycle). Each specimen was aseptically deposited on Macconkey agar. Subsequently, 5 µL of Escherichia coliATCC 25922 saline solution [108CFU mL-1] was deposited in center of the SMS specimen and the dish incubated at36°C/ 48h. Reading was performed by the presence or absence of bacterial growth typical of the species under the SMS, observed on the back of Petri dish. The lowest penetration rate observed was 60% for one of the brands in the virgin condition, and 75% for two brands in the processed condition. Statistical analysis showed an association between bacterial penetration and the evaluated group, this association being valid only in the virgin condition. The different SMS behave similarly in terms of resistance to bacterial penetration after being processed. The data show that moisture can assist in bacterial transport through sterilized SMS. Therefore, SMS packages are not able to prevent bacterial penetration, and possibly other microorganisms, when in aqueous vehicles, offering a potential risk of breaking the aseptic chain. Thus, care must be taken in routines for handling and storage sterile packaging.


Subject(s)
Product Packaging/instrumentation , Containment of Biohazards/instrumentation , Dental Offices/organization & administration , Humidity/prevention & control , Sterilization/instrumentation , Infection Control/instrumentation , Evaluation Study , Drug Packaging/instrumentation , Saline Solution/analysis , COVID-19/prevention & control , Microbiological Phenomena/immunology
3.
Arq. bras. oftalmol ; 82(1): 51-55, Jan.-Feb. 2019. tab, graf
Article in English | LILACS | ID: biblio-973878

ABSTRACT

ABSTRACT Purpose: This study aimed to determine the variation in diameters of outer and inner apertures of eyedropper tips using a computer vision system. Standardizing the size of eye drop nozzles is crucial to reduce the treatment cost of chronic eye diseases and to ensure a continued use of medication. An eyedropper volume of >20 µL (maximum storage of the conjunctival sac) causes medication wastage and increases treatment costs. Methods: We measured the diameters of the outer and inner apertures of eyedropper tips and evaluated variations in diameters using a computerized visual inspection system. Results: The computer visual inspection system identified anomalies in the apertures of eyedropper tips that resulted in diameter variations. Conclusions: The results of the present study show discrepancies in diameters of eyedropper tips, suggesting a variation in eyedropper size and medication wastage.


RESUMO Objetivo: Este estudo teve como objetivo determinar a variação dos diâmetros das aberturas externa e interna dos bicos conta-gotas utilizando sistema de visão computacional. A padronização do tamanho dos colírios conta-gotas é importante para reduzir o custo do tratamento de doenças crônicas e garantir o uso contínuo de medicamentos. O volume da gota maior do que 20 µl (volume de armazenamento máximo do saco conjuntival) gera desperdício da medicação e aumenta o custo do tratamento. Métodos: Medimos os diâmetros das aberturas externa e interna das pontas dos conta-gotas e avaliamos as variações no diâmetro usando um sistema de inspeção visual computadorizado. Resultados: O sistema de inspeção visual por computador identificou anomalias nas aberturas dos bicos dos frascos conta-gotas que resultaram em variações de diâmetro. Conclusões: Os resultados do presente estudo mostram discrepâncias nos diâmetros dos bicos dos frascos dos conta-gotas, sugerindo uma variação no tamanho das gotas e no desperdício de remédios.


Subject(s)
Ophthalmic Solutions/administration & dosage , Artificial Intelligence , Drug Packaging/standards , Reference Standards , Analysis of Variance , Administration, Ophthalmic
4.
Translational and Clinical Pharmacology ; : 73-79, 2019.
Article in English | WPRIM | ID: wpr-761931

ABSTRACT

Population pharmacokinetic analysis and modeling procedures typically require estimates of both population and individual pharmacokinetic parameters. However, only some of these parameters are contained in models and only parameters in the model can be estimated. In this paper, we introduce a new R package, PKconverter, to calculate pharmacokinetic parameters using the relationships among them. After fitting the model, other parameters can be calculated from the functional relationship among the parameters. PKconverter provides the functions to calculate whole parameters along with a Shiny application for converting the parameters. With this package, it is also possible to calculate the standard errors of the other parameters that are not in the model and estimate individual parameters simultaneously.


Subject(s)
Drug Packaging , Pharmaceutical Preparations , Models, Biological , Computer Simulation , Software
6.
Philippine Journal of Nursing ; : 14-17, 2018.
Article in English | WPRIM | ID: wpr-960336

ABSTRACT

@#<p style="text-align: justify;">As observed in today's health care setting, ampules, which are designed for single-use are still persistently reused when there is a drug left-over, in order to aid the patients lessen the cost of health care. Leaving the ampules exposed, covered with a micropore or cotton plug in the patient's immediate bedside are believed to be beneficial in controlling contamination. This study aimed to compare the practices in safekeeping of opened single-use ampules in a closed plastic container in two environments utilizing a 2 x 3 experimental factorial research design. The specimens were collected from 180 ampules' neck after 6 hours of exposure, which were then cultured; the resultant colony forming units were counted expressed in CFU/mL. The use of various practices in safekeeping, use of a closed plastic container and two environments were not significant in preventing contamination. Results demonstrated that none of the current practices in safekeeping was effective in controlling the number of microbial contaminants. Hence adherence to their nature, "single-use" must be advocated despite circumstance of having a drug left over.</p>


Subject(s)
Drug Contamination , Drug Packaging
7.
Arq. bras. oftalmol ; 80(2): 108-113, Mar.-Apr. 2017. tab, graf
Article in English | LILACS | ID: biblio-838784

ABSTRACT

ABSTRACT Purpose: Avastin® (bevacizumab) is an anti-vascular endothelial growth factor (VEGF) monoclonal antibody given as an off-label drug by intravitreal administration for treatment of ocular diseases. The drug's clinical application and its cost-benefit profile has generated demand for its division into single-use vials to meet the low volume and low-cost doses necessary for intraocular administration. However, the safety of compounding the drug in single-use vials is still under discussion. In this study, the stability and efficacy of Avastin® repacked in individual single-use glass vials and glass ampoules by external compounding pharmacies were evaluated. Methods: Polyacrylamide gel electrophoresis (PAGE), size-exclusion chromatography (SEC), dynamic light scattering (DLS), and turbidimetry were selected to detect the formation of aggregates of various sizes. Changes in bevacizumab biological efficacy were investigated by using an enzyme-linked immunosorbent assay (ELISA). Results: Repacked and reference bevacizumab showed similar results when analyzed by PAGE. By SEC, a slight increase in high molecular weight aggregates and a reduction in bevacizumab monomers were observed in the products of the three compounding pharmacies relative to those in the reference bevacizumab. A comparison of repacked and reference SEC chromatograms showed that the mean monomer loss was ≤1% for all compounding pharmacies. Protein aggregates in the nanometer- and micrometer-size ranges were not detected by DLS and turbidimetry. In the efficacy assay, the biological function of repacked bevacizumab was preserved, with <3% loss of VEGF binding capacity relative to that of the reference. Conclusion: The results showed that bevacizumab remained stable after compounding in ampoules and single-use glass vials; no significant aggregation, fragmentation, or loss of biological activity was observed.


RESUMO Objetivos: Avastin® (bevacizumabe) é um anticorpo monoclonal inibidor do fator de crescimento endotelial de vasos (VEGF) utilizado "off-label" por meio de administração intravítrea para o tratamento de doenças oculares. A sua aplicação clínica associada ao custo-benefício do medicamento gerou uma demanda para seu fracionamento em frascos de dose única para utilização pela via intraocular. No entanto, a segurança do fracionamento do anticorpo em frascos de dose única ainda é alvo de discussão. Neste trabalho, a estabilidade e a eficácia do Avastin® fracionado em frascos ou ampolas de vidro de dose unitária por farmácias de manipulação do mercado foram avaliadas. Métodos: As técnicas de eletroforese em gel de poliacrilamida (PAGE), cromatografia por exclusão de tamanho (SEC), espalhamento dinâmico da luz (DLS) e turbidimetria foram empregadas para avaliar a formação de agregados de diferentes tamanhos. Alterações na atividade biológica do bevacizumabe foram estudadas utilizando ELISA. Resultados: Amostras referência e do bevacizumabe fracionado apresentaram resultados semelhantes quando analisado por gel de poliacrilamida. Por cromatografia por exclusão de tamanho, um pequeno aumento na quantidade de agregados de alta massa molar seguido de uma redução nos monômeros do bevacizumabe foram observados para as amostras das três farmácias de manipulação quando comparado ao referência. A comparação dos cromatogramas mostrou uma quantidade de redução do monômero inferior a 1% para todas as amostras fracionadas. Por espalhamento dinâmico da luz e turbidimetria, não foram detectados agregados de proteína na faixa de tamanho de micrômetro e nanômetro. No ensaio de eficácia, o bevacizumabe fracionado preservou sua função biológica pois apresentou menos de 3% de perda na capacidade de ligação ao VEGF quando comparado ao referência. Conclusão: Este estudo sugere que o bevacizumabe se mantem estável após fracionamento em ampolas e frascos de vidro de dose unitária pois não foram observadas agregação e/ou fragmentação de proteínas e perda de atividade biológica em quan tidades significativas.


Subject(s)
Quality Control , Angiogenesis Inhibitors/chemistry , Drug Packaging , Bevacizumab/chemistry , Enzyme-Linked Immunosorbent Assay/methods , Chromatography, Gel/methods , Angiogenesis Inhibitors/analysis , Vascular Endothelial Growth Factor A/analysis , Drug Stability , Electrophoresis, Polyacrylamide Gel/methods , Intravitreal Injections , Bevacizumab/analysis , Dynamic Light Scattering/methods , Molecular Weight , Nephelometry and Turbidimetry/methods
8.
Rev. bras. oftalmol ; 76(1): 23-27, Jan.-Feb. 2017. tab, graf
Article in Portuguese | LILACS | ID: biblio-844060

ABSTRACT

RESUMO Objetivo: Avaliar a variação intra e interexaminadores do volume de gotas dispensados de frascos de colírios lubrificantes disponíveis no mercado. Métodos: Foram estudados cinco frascos de colírios lubrificantes e dezenove voluntários participaram deste estudo. A massa média de gotas de 20µl dos colírios foi obtida utilizando micropipeta e balança de precisão e como padrão para comparação com a massa das gotas obtidas pelos voluntários. Cinco gotas de cada frasco foram pesadas individualmente com o tubo de colírio perpendicular à balança, usando o primeiro e segundo dedos da mão direita, de forma que a pressão fosse aplicada somente no meio do frasco. Os experimentos foram realizados em uma sala climatizada a temperatura ambiente (21±1°C). Resultados: Todos os frascos de colírios apresentaram variação estatisticamente significante das massas das gotas obtidas pelos examinadores quando comparadas com a massa média padrão de 0,0182±0,0014g, com exceção da comparação entre os dados do colírio A com o colírio D, que não apresentou variação estatisticamente significante. Conclusão: O presente estudo demonstra a ausência de uniformidade das gotas dispensadas pelos frascos de colírios disponíveis no mercado e a sua inadequação à real necessidade, uma vez que as gotas dispensadas são maiores do que o indicado. Esse fato torna-se um problema quando se trata de período de tratamento prolongado, especialmente com colírios dispendiosos como os indicados para a terapêutica do glaucoma. Nesse sentido, a padronização das gotas de colírios se faz necessária.


ABSTRACT Objective: To evaluate the intra and inter variations of eye drops volume dispensed from bottles available on the market. Methods: Five bottles of lubricant eye drops were studied and nineteen volunteers participated in this study. The average mass from 20µl of eye drops was obtained using accuracy micropipette and balance, and used as standard for comparison with the mass of the drops obtained by the volunteers. Five drops of each vial were individually weighed with the tube perpendicular to the balance, using the first and second fingers of the right hand, so that the pressure was applied only in the middle of the flask. The experiments were performed in a room temperature (21±1°C). Results: All eye drops bottles showed a statistically significant variation on masses of the drops obtained by examiners when compared with the standard average weight of 0.0182±0,0014g, except when compared A with D eye drops, with no statistically significant variation. Conclusion: This study demonstrates the lack of uniformity of drops dispensed by eye drops bottles available in the market and its inadequacy to the real need, since the dispensed drops are larger than indicated.This fact becomes a problem when it comes to long treatment period, especially with expensive drops as indicated for glaucoma therapy. In this sense, the standardization of drops of eye drops is necessary.


Subject(s)
Humans , Male , Female , Adolescent , Adult , Middle Aged , Drug Packaging/standards , Lubricant Eye Drops/administration & dosage , Lubricant Eye Drops/standards , Instillation, Drug , Drug Administration Schedule , Drug Costs , Equipment Design , Lubricant Eye Drops/economics
9.
Ciênc. cuid. saúde ; 15(4): 662-668, Out.-Dez. 2016.
Article in Portuguese | LILACS, BDENF | ID: biblio-974888

ABSTRACT

RESUMO As unidades básicas de saúde possuem grande demanda de procedimentos médicos, de enfermagem e odontológicos, dos quais dependem a segurança da assistência e do paciente. O objetivo deste estudo foi compreender como enfermeiros, técnicos, auxiliares em enfermagem e auxiliares de consultório dentário procedem no cuidado com embalagens, acondicionamento e tempo de guarda de materiais esterilizados nas unidades de saúde da atenção básica. Trata-se de uma pesquisa de caráter descritivo e exploratório, com abordagem qualitativa. Os participantes da pesquisa foram enfermeiros, técnicos de enfermagem e auxiliares de consultório dentário, atuantes em unidades básicas de saúde de três cidades do interior do Estado do Rio Grande do Sul. Os dados foram produzidos por meio de entrevistas semiestruturadas realizadas nos meses de outubro e dezembro de 2015 e submetidos a análise de conteúdo. Evidenciou-se que os serviços estudados carecem de estruturação, organização e definição de processos no que tange o tipo de embalagem e o acondicionamento de artigos críticos. Conclui-se que a assistência aos usuários, no que se refere a procedimentos que utilizam materiais esterilizados, está exposta a riscos, fragilizando a segurança do paciente, evidenciando a necessidade de capacitação continua dos profissionais.


RESUMEN Las unidades básicas de salud poseen gran demanda de procedimientos médicos, de enfermería y odontológicos, de los cuales depende la seguridad de la atención y del paciente. El objetivo de este estudio fue comprender cómo enfermeros, técnicos, auxiliares en enfermería y auxiliares de consultorio dentario proceden en el cuidado con envases, acondicionamiento y tiempo de guarda de materiales esterilizados en las unidades de salud de la atención básica. Se trata de una investigación de carácter descriptivo y exploratorio, con abordaje cualitativo. Los participantes de la investigación fueron enfermeros, técnicos de enfermería y auxiliares de consultorio dentario, actuantes en unidades básicas de salud de tres ciudades del interior del Estado de Rio Grande do Sul-Brasil. Los datos fueron producidos por medio de entrevistas semiestructuradas realizadas en los meses de octubre y diciembre de 2015 y sometidos al análisis de contenido. Se evidenció que los servicios estudiados carecen de estructuración, organización y definición de procesos con relación al tipo de envase y el acondicionamiento de artículos críticos. Se concluye que la atención a los usuarios, en lo que se refiere a procedimientos que utilizan materiales esterilizados, está expuesta a riesgos, fragilizando la seguridad del paciente, evidenciando la necesidad de capacitación continua de los profesionales.


ABSTRACT The basic health units have great demand for medical, nursing and dentistry procedures, on which the security of the assistance and the patient depends. The objective of this study was to understand how nurses, nursing technicians, assistants and dental office assistants proceed in managing packaging, guard and distribution of sterile materials in the health units of the primary care. This is a descriptive and exploratory research, with a qualitative approach. The participants of the research were nurses, nursing technicians and assistants of dental office operating in basic health units of three cities in the State of Rio Grande do Sul. The data were generated through semi-structured interviews between October and December 2015 and assessed through content analysis. One evidenced that the studied services lack structure, organization and process definition with regard to the packaging of critical objects. The conclusion is that the assistance to users with respect to procedures using sterile materials are exposed to risks, weakening the patient's safety, emphasizing the need for continuous training of professionals.


Subject(s)
Humans , Male , Female , Primary Health Care/organization & administration , Sterilization/instrumentation , Product Packaging/instrumentation , Drug Packaging/instrumentation , Patient Safety , Dental Auxiliaries , Dental Offices/organization & administration , Equipment and Supplies , Licensed Practical Nurses , Nurses , Nursing Assistants
10.
Einstein (Säo Paulo) ; 14(2): 226-230, tab, graf
Article in English | LILACS | ID: lil-788037

ABSTRACT

ABSTRACT Objective To compare sterility and microbial (bacteria and fungi) load in the outer part of hyperbaric bupivacaine (Neocaína®) in ampoule and bupivacaine in vial, in conventional and sterile pack formulations. Methods The sterile packs were divided into two groups: G1 (n=16) with ampoules and G2 (n=16) with vials. Conventional formulations were divided into two groups, being G3 (n=16) with ampoules and G4 (n=16) with vials. The ampoules and vials were opened and had their content drawn. The empty bottles were then placed in sterile plastic bags and sent for analysis of microbial load (bacteria and fungi) and sterility testing. Data were analyzed using the χ2 test with Yates correction, and 95% confidence interval. Results G1 and G2 showed no bacterial growth when compared to conventional groups (p<0.001). The most common agent in conventional microbiological samples was Staphylococcus aureus. There was no fungal growth in both groups. Conclusion The use of (sterile pack) reduces the microbial load of bottles, and would decrease the chance of exposure to potential contamination of the anesthetic solution.


RESUMO Objetivo Comparar a esterilidade e a carga microbiana (bactérias e fungos) da parte externa dos frascos de envasamento de bupivacaína hiperbárica (Neocaína®) em ampola e bupivacaína em frasco-ampola das apresentações convencional e estéril (sterile pack). Métodos As apresentações estéreis (sterile pack) foram distribuídas em dois grupos, sendo que o G1 (n=16) continha as ampolas e o G2 (n=16), os frascos-ampola. As apresentações convencionais foram distribuídas em dois grupos, a saber G3 (n=16) com as ampolas e G4 (n=16) com os frascos-ampola. As ampolas e os frascos-ampolas eram abertos e tinham seu conteúdo aspirado. Os frascos vazios eram, então, acondicionados em sacos plásticos estéreis e enviados para análise quanto à carga microbiana (bactérias e fungos), bem como para o teste de esterilidade. Os dados foram analisados por meio do teste χ2 com correção Yates com intervalo de confiança de 95%. Resultados Os grupos G1 e G2 não apresentaram crescimento bacteriano quando comparado aos grupos convencionais (p<0,001). O microbiano mais comum nas amostras convencionais foi o Staphylococcus aureus. Não houve crescimento de fungos em nenhum dos grupos. Conclusão O uso de embalagens estéreis (sterile pack) diminui a carga microbiana dos frascos de envasamentos, o que diminuiria a chance de exposição a uma potencial contaminação da solução anestésica.


Subject(s)
Bupivacaine , Sterilization/methods , Drug Contamination/prevention & control , Equipment Contamination/prevention & control , Drug Packaging/methods , Anesthetics, Local , Staphylococcus aureus/growth & development , Bacillus/growth & development , Time Factors , Colony Count, Microbial , Reproducibility of Results , Risk Factors , Equipment and Supplies/microbiology , Micrococcus/growth & development
11.
Rev. bras. oftalmol ; 74(6): 339-344, nov.-dez. 2015. tab, graf
Article in English | LILACS | ID: lil-767076

ABSTRACT

RESUMO Objetivo: Determinar o volume médio das gotas produzidas pelos colírios lubrificantes em diferentes ângulos de inclinação e determinar o custo médio do tratamento. Métodos: Determinação do volume da gota de 3 frascos originais dos colírios lubrificantes Artelac®, Hylo Comod®, Lacrima® Plus, Systane® UL, Lacrifilm®, Hyabak®, Lacribell®, Ecofilm®, Mirugell®, Plenigell®, Fresh Tears®, Optive® e Endura® à inclinação de 90º e 45º. Determinou-se o número médio de gotas em cada frasco e foi feita avaliação farmacoeconômica dos colírios. Resultados: O volume das gotas variou de 32,2 a 64,0 µL a 45o e de 29,1 a 65,1 µL a 90o. A diferença entre as gotas em cada inclinação foi de 2 a 24% e o custo anual dos colírios de acordo com a inclinação variou de R$2,73 a R$130,73. A Duração Máxima de Tratamento (DMT) foi de 29,3 a 51,4 dias na inclinação de 45o, e de 28,8 a 48,4 dias a 90º, sendo que a diferença na DMT foi de 0,5 até 8 dias a mais ou a menos, de acordo com a marca. Conclusão: Nenhum dos colírios estudados apresentou gotas ideais para o olho humano, levando a um desperdício do produto e maior custo para o fabricante e para o consumidor. Percebemos que existe uma variação significativa no volume da gota de acordo com a inclinação do frasco, e que uma variação maior do que 10% traria impactos financeiros para o paciente.


ABSTRACT Objective: To determine the mean drop volume produced by artificial tear solutions in different inclination angles and to determine the mean cost of the treatment. Methods: The drop volume of 3 original bottles of the artificial tear solutions Artelac®, Hylo Comod®, Lacrima® Plus, Systane® UL, Lacrifilm®, Hyabak®, Lacribell®, Ecofilm®, Mirugell®, Plenigell®, Fresh Tears®, Optive® and Endura® were determined at the inclination of 90º and 45º. The mean number of drops in each bottle was determined and a pharmacoeconomic evaluation of the drops was made. Results: The drop volume ranged from 32.2 to 64.0 µL at 45º and from 29.1 to 65.1 µL at 90º. The difference between drops in each inclination varied from 2 to 24%. The annual cost was from R$2,73 to R$130,73 according to the inclination of the bottle. The Maximum Duration of Treatment (MDT) was from 29.3 to 51.4 days at 45o and from 28.8 to 48.4 days at 90º, being the difference in MDT from 0.5 to 8 more or less days depending on each brand. Conclusion: None of the collyria studied presented ideal drops for human eyes, leading to a waste of the product and higher cost for the manufacturer and the consumer. We noted that there is a significant variation in the drop volume according to the inclination of the bottle, and that a variation of over 10% would bring financial impact for the patient.


Subject(s)
Economics, Pharmaceutical , Densitometry/methods , Lubricant Eye Drops/administration & dosage , Lubricant Eye Drops/economics , Lubricant Eye Drops/standards , Instillation, Drug , Drug Costs , Drug Packaging/economics , Drug Packaging/standards
12.
Rev. cuba. farm ; 49(2)abr.-jun. 2015. ilus, tab
Article in Spanish | LILACS, CUMED | ID: lil-776409

ABSTRACT

Introducción: el D-004 es un ingrediente farmacéutico activo obtenido de los frutos de la palma real cubana (Roystonea regia), compuesto fundamentalmente por una mezcla de ácidos grasos libres entre 8 y 18 átomos de carbono, con potencialidades en el tratamiento de la hiperplasia prostática benigna. Objetivo: determinar la vida útil del D‒004 en frascos de polietileno de alta densidad en las zonas climáticas IV y II. Métodos: muestras de tres lotes pilotos de D-004, envasadas en frascos blancos de polietileno de alta densidad y protegidos por cajas de cartón, se colocaron en las condiciones de las zonas climáticas IV (30 ºC/70 % HR) y II (25 ºC/60 % HR). Se determinaron las características organolépticas y los contenidos de material insaponificable, ácidos grasos y microbiológicos desde el tiempo inicial hasta los 36 meses, y se determinaron gráficamente los tiempos de vida útil en ambas zonas. Resultados: en las dos zonas climáticas el D‒004 cumplió con los parámetros de estabilidad evaluados durante los primeros 33 meses, pero a los 36 meses el contenido de ácidos fue inferior al límite establecido en varias de las muestras. Los análisis de regresión permitieron determinar tiempos de vida útil del D‒004 en las zonas IV y II. Conclusiones: se demostró que el ingrediente activo D‒004 que se obtuvo a escala piloto, se envasa en frascos de polietileno de alta densidad y protegido por un envase secundario (caja de cartón), presenta una vida útil de 30 y 32 meses en las zonas climáticas IV y II, respectivamente(AU)


Introduction: D­004 is a pharmaceutical active ingredient obtained from the Cuban royal palm fruits (Roystonea regia), mainly composed by a mixture of free fatty acids between 8 and 18 carbon atoms, potentially useful to treat benign prostatic hyperplasia. Objective: to determine the shelf life of D­004 in high-density polyethylene flasks in climatic zones IV and II. Methods: samples of three pilot batches of D­004, packed in white high-density polyethylene flasks and protected by cardboard boxes, were placed under conditions of the climatic zones IV (30 ºC/70 % RH) and II (25 ºC / 60 % RH). Organoleptic characteristics and unsaponifiable matter, fatty acids and microbiological contents were determined from the initial time till 36 months, and shelf lives were graphically determined in both zones. Results: in the two climatic zones, the D­004 fulfilled the tested stability parameters during the first 33 months, but at the month 36th, the acid content in several samples was lower than the set limit. The regression analyses allowed determining the shelf lives of D­004 in climatic zones IV and II. Conclusions: it was demonstrated that the active ingredient D­004, obtained at pilot scale, packed in high density polyethylene flasks and protected by a secondary container (cardboard box), exhibits a shelf life of 30 and 32 months in the climatic zones IV and II, respectively(AU)


Subject(s)
Humans , Male , Plants, Medicinal , Prostatic Hyperplasia/therapy , Enzyme Stability , Palm Oil/therapeutic use , Drug Packaging
13.
São Paulo med. j ; 133(2): 91-100, Mar-Apr/2015. tab
Article in English | LILACS | ID: lil-746648

ABSTRACT

CONTEXT AND OBJECTIVES: Package leaflets are necessary for safe use of medicines. The aims of the present study were: 1) to assess the compliance between the content of the package leaflets and the specifications of the pharmaceutical regulations; and 2) to identify potential safety issues for patients. DESIGN AND SETTING: Qualitative descriptive study, involving all the package leaflets of branded medicines from the three most consumed therapeutic groups in Portugal, analyzed in the Department of Pharmacoepidemiology, School of Pharmacy, University of Lisbon. METHODS: A checklist validated through an expert consensus process was used to gather the data. The content of each package leaflet in the sample was classified as compliant or non-compliant with compulsory regulatory issues (i.e. stated dosage and descriptions of adverse reactions) and optional regulatory issues (i.e. adverse reaction frequency, symptoms and procedures in cases of overdose). RESULTS: A total of 651 package leaflets were identified. Overall, the package leaflets were found to be compliant with the compulsory regulatory issues. However, the optional regulatory issues were only addressed in around half of the sample of package leaflets, which made it possible to identify some situations of potentially compromised drug safety. CONCLUSION: Ideally, the methodologies for package leaflet approval should be reviewed and optimized as a way of ensuring the inclusion of the minimum essential information for safe use of medicines. .


CONTEXTO E OBJETIVO: As bulas dos medicamentos são necessárias para a sua utilização segura. Os objetivos do presente estudo foram: 1) avaliar a adequação entre o conteúdo das bulas e as especificações da regulação farmacêutica e 2) identificar os aspectos que potencialmente possam comprometer a utilização segura dos medicamentos pelos doentes. TIPO DE ESTUDO E LOCAL: Estudo descritivo qualitativo com a inclusão de todas as bulas dos medicamentos de marca dos três grupos terapêuticos mais consumidos em Portugal, analisados no Departamento de Farmacoepidemiologia da Faculdade de Farmácia da Universidade de Lisboa. MÉTODOS: Utilização de uma checklist para recolher os dados. A checklist foi validada por um processo de consenso entre peritos. O conteúdo de cada uma das bulas da amostra foi classificado em relação à adequação aos aspectos regulatórios obrigatórios, como a descrição das reações adversas, dose e frequência de administração, e à adequação dos aspectos regulatórios facultativos, como a frequência das reações adversas e sintomas e procedimentos em caso de sobredosagem. RESULTADOS: Foram identificadas 651 bulas. Em termos gerais, todas as bulas foram consideradas conformes em relação aos aspectos regulatórios obrigatórios. No entanto, os aspectos regulatórios opcionais foram descritos em apenas cerca de metade da amostra de bulas, o que permite a identificação de situações susceptíveis de comprometer a utilização segura dos medicamentos. CONCLUSÃO: Idealmente as metodologias de aprovação das bulas devem ser revistas e otimizadas de forma a assegurar um mínimo de informação essencial para a utilização segura dos medicamentos. .


Subject(s)
Humans , Drug Labeling/standards , Drug Packaging/standards , Legislation, Drug/standards , Comprehension , Consumer Health Information , Consumer Product Safety/legislation & jurisprudence , Drug Labeling/classification , Drug Packaging/classification , European Union/organization & administration , Portugal , Qualitative Research
14.
China Journal of Chinese Materia Medica ; (24): 3319-3322, 2015.
Article in Chinese | WPRIM | ID: wpr-304811

ABSTRACT

With the development of society and the improvement of people's living standards, the effect of Chinese medicine in treatment and health care is more and more prominent. The herbal decoction pieces are the important part of Chinese medicine,it can be applied directly to clinical treatment and it's also the raw material of Chinese patent medicine. Therefore, the quality of herbal decoction pieces is quite important. The parts of the production of herbal decoction pieces are numerous, and there are possibilities of adverse effects on the quality of the herbal decoction pieces in every part. In this paper, we based on the production chain of herbal decoction pieces, analyzed the main problem that affect the quality of herbal decoction pieces in the part of selection of Chinese herbal medicines, planting, purchasing, processing, packaging, storage and transport, such as the poor quality of seed and seedlings of plant-based Chinese medicines, some plants left their place of origin and have been introduced in the place that is not suitable for this kind of plant, the insufficient growth time and the excessive harmful substances. The purchasers and the accepters lack of professional knowledge and professional ethics. The mechanism of processing is not clear, the standards can not be uniformed, and lack of qualified person in processing, etc. So we suggest: intensify the basic research of key scientific issues. Improve the quality of persons who work in herbal decoction pieces; Establish an "integration" mode of operation in herbal decoction pieces enterprise; Breeding high quality plant resources, establish the large-scale planting basement; Make the packing of herbal decoction pieces standard; Establish the modernization traditional Chinese medicine logistics enterprise.


Subject(s)
Humans , Chemistry, Pharmaceutical , Economics , Workforce , Reference Standards , Drug Packaging , Economics , Workforce , Reference Standards , Drug Storage , Economics , Reference Standards , Drugs, Chinese Herbal , Chemistry , Reference Standards , Medicine, Chinese Traditional , Economics , Reference Standards , Quality Control
16.
Article in Portuguese | LILACS | ID: lil-718808

ABSTRACT

As propriedades de barreira à umidade de embalagens plásticas para produtos oftálmicos de capacidade nominal de 20 mL e terminação 15 mm nos formatos cilíndrico e oval, de diferentes composições (100% Polietileno de Baixa Densidade (PEBD), 100% Polipropileno (PP) e blendas com percentuais 10% e 40% de Polietileno de Alta Densidade (PEAD) em PEBD), foram estudadas neste trabalho. Foi verificada também a influência do batoque gotejador (de maior ou menor orifício de dosagem) e a influência do fechamento na taxa de transmissão de vapor d'água. O trabalho foi conduzido sob duas condições de estocagem a 25 ºC/40% UR e a 40 ºC/75% UR. Verificou-se que o diâmetro do orifício gotejador não interferiu significativamente na perda de peso da embalagem avaliada a 25 ºC/40% UR. Sob a condição de estocagem a 40 ºC/75% UR verificou-se um aumento da taxa de transmissão de vapor d'água das embalagens comparativamente as mesmas embalagens avaliadas a 25 ºC/40% UR. O sistema de fechamento não favoreceu um acréscimo significativo da taxa de transmissão de vapor d'água, o que indica que a permeação ocorreu principalmente através do corpo da embalagem plástica. A propriedade de barreira foi influenciada pela composição da embalagem plástica chegando a uma redução média de 47% na taxa de transmissão de vapor d'água para a embalagem de PEBD com 40% PEAD em relação à embalagem com100% PEBD de formato cilíndrico. Verificou-se ainda que o formato oval, por apresentar uma maior área superficial exposta comparativamente à embalagem de formato cilíndrico, com regiões de menor espessura de parede, pode favorecer um ligeiro aumento da taxa de transmissão de vapor d'água da embalagem...


The moisture barrier properties of plastic ophthalmic product bottles of nominal capacity 20 mL and finish diameter 15 mm, in cylindrical and oval shapes, with various compositions (100% Low Density Polyethylene(LDPE), 100% polypropylene (PP) and blends with10% and 40% High Density Polyethylene (HDPE) in LDPE), were assessed in this study. The effects of the drop hole size (higher or lower dosage diameter) and the screw cap on the Water Vapor Transmission Rate (WVTR) were also assessed. This study was conducted under two conditions of storage, at 25 °C/40% RH and 40 °C/75% RH. It was observed that the drop hole diameter did not influence significantly the weight loss of the container at 25 °C/40% RH, whereas at 40°C/75% RH, the WVTR of the container was higher than that of the same package at 25 °C/40% RH.The screw cap did not significantly affect the WVTR, indicating that the permeation occurred primarily through the plastic body. The barrier property was influenced by the composition of the plastic container; thus, compared to LDPE, there was a mean reduction of 47% in the WVTR of LDPE blended with 40% HDPE, when both bottles were cylindrical. It was found that the oval shape, because of the larger exposed surface area relative to the cylindrical shape, as well as the presence of regions of thinner wall, can favor a slight increase in the WVTR of the bottle...


Subject(s)
Drug Packaging , Humidity , Ophthalmic Solutions/analysis , Steam/adverse effects
17.
China Journal of Chinese Materia Medica ; (24): 981-991, 2014.
Article in Chinese | WPRIM | ID: wpr-321381

ABSTRACT

To study the effect of different storage conditions and storage time on herb quality of Lonicera macranthoides, different packaging materials including vacuum plastic bags, plastic bags, woven bags, sealed with endometrial bags, paper bags, sack bags were selected for the study under different storage conditions including room temperature, 5 degrees C refrigerator, low temperature of - 20 degrees C refrigerator and desiccator. Twenty-four batches of samples were used for the study, and active ingredients were determined. The experimental results showed that the ingredients in each storage group changed with the storage time, storage conditions (storage environment, packaging). Under the same storage time, the storage environment (temperature, humidity) had effect on the stability of herb quality. Low temperature had less effect on herb quality. The effect of packaging on herb quality was as following: plastic vacuum packaging > woven with endometrial sealed packaging > plastic bag > woven bag > sack bags > paper bags. Under the same storage conditions, with the increase of storage time, caffeic acid content increased slowly, and other five ingredients content decreased gradually. Storage time affected significantly on the intrinsic quality (chemical composition) and appearance of herb. It is suggested that low temperature (5 degrees C), dark and sealed storage are suitable for storage of L. macranthoides herb, the storage time should be not more than 24 months.


Subject(s)
Desiccation , Drug Packaging , Drug Storage , Methods , Drugs, Chinese Herbal , Chemistry , Lonicera , Chemistry , Organic Chemicals , Quality Control , Time Factors
18.
China Journal of Chinese Materia Medica ; (24): 2428-2431, 2014.
Article in Chinese | WPRIM | ID: wpr-299797

ABSTRACT

<p><b>OBJECTIVE</b>To elucidate the necessary and research of accelerating basic research of Chinese standard pieces as standard materials.</p><p><b>METHOD</b>According to over 10 years accumulated experience and be keenly aware of the author, the evaluation method of standardized processing technology and Chinese pieces quality, aimed at consummated the standard material of the quality evaluation of Chinese herbal pieces at the current situation, and inaccordance with the need of improving quality standard system of Chinese herbal pieces, illustrate the necessity of accelerating basic research of Chinese standard pieces as standard materials; from the technical specification for collecting and processing of raw materials, and the technical specification, homogenized sample, packaging, storage and etc., for processing of candidate standard pieces, determine the methods and steps of technical specifications for standard pieces as the standard substance, determine the methods and steps of technical specifications for standard pieces as the standard substance.</p><p><b>RESULT AND CONCLUSION</b>To speed up the basic research of standard of Chinese medicine pieces as of standard material is very necessary. The research objective is to specificate the processing technical for a number of standard pieces, to identify technical specifications and to ascertain the guiding principle and technical specification of decoction pieces as standard substance. This research will provide basic scientific data relevant national departments to apply for the accreditation of the standard substance.</p>


Subject(s)
Drug Packaging , Reference Standards , Drugs, Chinese Herbal , Chemistry , Reference Standards , Medicine, Chinese Traditional , Reference Standards , Quality Control
19.
Rev. bras. anestesiol ; 63(4): 362-365, jul.-ago. 2013. ilus, tab
Article in Portuguese | LILACS | ID: lil-680147

ABSTRACT

O anestesiologista deve estar ciente das causas, do diagnóstico e do tratamento de embolia venosa e adotar padrões de prática para prevenir sua ocorrência. Embora a embolia gasosa seja uma complicação conhecida da cesariana, descrevemos um caso raro de desatenção que causou embolia gasosa iatrogênica quase fatal durante uma cesariana sob raquianestesia. uma das razões para o uso de bolsas autorretráteis para infusão em vez dos frascos convencionais de vidro ou plástico é a precaução contra embolia gasosa. Também demonstramos o risco de embolia venosa com o uso de dois tipos de bolsas plásticas retráteis (à base de cloreto de polivinil [PVC] e de polipropileno) para líquidos intravenosos. As bolsas para líquidos sem saídas autovedantes apresentam risco de embolia gasosa se o sistema de fechamento estiver quebrado, enquanto a flexibilidade da bolsa limita a quantidade de entrada de ar. bolsas à base de pvc, que têm mais flexibilidade, apresentam risco significativamente menor de entrada de ar quando o equipo de administração intravenosa (IV) é desconectado da saída. usar uma bolsa pressurizada para infusão rápida sem verificar e esvaziar todo o ar da bolsa IV pode ser perigoso.


The anesthesiologist must be aware of the causes, diagnosis and treatment of venous air embolism and adopt the practice patterns to prevent its occurrence. Although venous air embolism is a known complication of cesarean section, we describe an unusual inattention that causes iatrogenic near fatal venous air embolism during a cesarean section under spinal anesthesia. One of the reasons for using self-collapsible intravenous (IV) infusion bags instead of conventional glass or plastic bottles is to take precaution against air embolism. We also demonstrated the risk of air embolism for two kinds of plastic collapsible intravenous fluid bags: polyvinyl chloride (PVC) and polypropylene-based. Fluid bags without self-sealing outlets pose a risk for air embolism if the closed system is broken down, while the flexibility of the bag limits the amount of air entry. PVC-based bags, which have more flexibility, have signifi cantly less risk of air entry when IV administration set is disconnected from the outlet. Using a pressure bag for rapid infusion can be dangerous without checking and emptying all air from the IV bag.


El anestesiólogo debe de estar consciente de las causas, del diagnóstico y del tratamiento de la embolia venosa, y adoptar los estándares de práctica para prevenir su aparecimiento. Aunque la embolia gaseosa sea una complicación conocida de la cesárea, describimos aquí un caso raro de falta de atención que causó embolia gaseosa iatrogénica casi fatal durante una cesárea bajo raquianestesia. Una de las razones para el uso de bolsas autoretráctiles para infusión en vez de los frascos convencionales de vidrio o plástico, es la precaución contra la embolia gaseosa. También demostramos riesgo de embolia venosa con el uso de dos tipos de bolsas plásticas retráctiles (a base de cloruro de polivinil [PVC] y de polipropileno) para líquidos intravenosos. Las bolsas para líquidos sin salidas de autosellado, tienen un riesgo de embolia gaseosa si el sistema de cierre está roto, mientras la flexibilidad de la bolsa limita la cantidad de entrada de aire. Bolsas hechas a base de PVC, y que tienen más flexibilidad, también tienen un riesgo signifi cativamente menor de entrada de aire cuando el equipo de administración intravenosa (IV) se apaga en la salida. Usar una bolsa de presión para la infusión rápida sin verifi car y vaciar todo el aire de la bolsa IV puede ser peligroso.


Subject(s)
Adult , Female , Humans , Cesarean Section , Embolism, Air/etiology , Intraoperative Complications/etiology , Drug Packaging , Fluid Therapy , Infusions, Intravenous , Polyvinyl Chloride , Risk Factors
20.
Braz. j. infect. dis ; 17(1): 69-73, Jan.-Feb. 2013. tab
Article in English | LILACS | ID: lil-665777

ABSTRACT

OBJECTIVES: Intravenous therapy is a complex procedure usually requiring the preparation of the medication in the clinical area before administration to the patient. Breaches in aseptic technique may result in microbial contaminations of vials which is a potential cause of different avoidable infections. We aimed to investigate the prevalence and pattern of microbial contamination of single- and multiple-dose vials in the largest pulmonary teaching hospital in Iran. METHODS: In a period of 2 months, opened single- and multiple-dose vials from different wards were sampled by a pharmacist. The name of the medication, ward, labeling of the vials, the date of opening, and storing temperature were recorded for each vial. Remained contents of each vial were cultured using appropriate bacterial and fungal growth media. RESULTS: Microbial contamination was identified in 11 of 205 (5.36%) of vials. The highest contamination rate was 14.28% for vials used in interventional bronchoscopy unit. The most frequent contaminated medication was insulin. Gram-positive bacteria (81.82%) were more significantly involved than gram-negative ones (9.09%) and fungi (9.09%), with the highest frequency for Staphylococcus epidermidis . CONCLUSIONS: Our data demonstrate that repeated use of vials especially if basic sterility measures are disobeyed can cause microbial contamination of administered products to the patients. Infection preventionists are responsible to train health care workers regarding aseptic techniques and apply guidelines for aseptic handling of intravenous solutions.


Subject(s)
Catheters/microbiology , Equipment Contamination/statistics & numerical data , Fungi/isolation & purification , Gram-Negative Bacteria/isolation & purification , Gram-Positive Bacteria/isolation & purification , Syringes/microbiology , Drug Contamination , Drug Packaging , Fungi/classification , Gram-Negative Bacteria/classification , Gram-Positive Bacteria/classification , Hospitals, Teaching , Iran
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