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1.
Clin Ter ; 171(2): e107-e109, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32141480

RESUMO

Extensive scientific evidence shows that there is a broad spectrum of substances used as adulterants, whose effects on the user's health may be extremely harmful. The degree of purity of the drugs most commonly abused is highly variable depending on the region or epidemiological context. Practices of drug adulteration have been substantially evolving over the years: a significant trend has been observed in the last decade indicating a decline in the average purity of most drugs. Although the most frequent adulterants of common street drugs have long been well known, the rise of synthetic opioids has inevitably entailed gaps in knowledge in terms of the substances being used and their composition, which constitutes an even greater threat to public health.


Assuntos
Analgésicos Opioides/efeitos adversos , Analgésicos Opioides/síntese química , Contaminação de Medicamentos , Drogas Ilícitas/efeitos adversos , Drogas Ilícitas/síntese química , Humanos , Saúde Pública , Transtornos Relacionados ao Uso de Substâncias , Medicamentos Sintéticos/efeitos adversos , Medicamentos Sintéticos/síntese química
2.
Int J Pharm Compd ; 24(1): 7-12, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32023210

RESUMO

Minimizing contamination by airborne particulates is essential in pharmaceutical compounding, and biosafety cabinets have long been among the most effective types of equipment used to achieve that goal. In this article, which is the second of a 2-part series on primary engineering controls, the 3 classes and various types of biosafety cabinets are reviewed. In those units, directed airflow and high-efficiency particulate air filtration sweep airborne contaminants away from the operator, the preparation, and/ or the environment. Factors to consider before operating a Class-2 biosafety cabinet (the unit most often used in compounding) are briefly discussed, information about technician certification and training is reviewed, and diagrams demonstrating the mechanism of operation of several Class-2 units are provided. In part 1 of this series, other types of primary engineering controls used in compounding (unidirectional airflow workstations, compounding aseptic isolators, and compounding aseptic containment isolators) are discussed.


Assuntos
Contenção de Riscos Biológicos , Contaminação de Medicamentos , Composição de Medicamentos/métodos , Filtração
3.
Z Gastroenterol ; 58(2): 127-132, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-32050283

RESUMO

BACKGROUND: In 1978 and 1979, contaminated anti-D immunoglobulin was used in the German Democratic Republic (GDR). As a result, several thousand women were, in the end, infected with hepatitis C. These women received medical attention, part of which was research on hepatitis C. Up to now, results of the research and data are being published in international journals. It remains unclear whether the affected women were asked to be subjects of the clinical research. METHODS: The authors analyzed historical sources and conducted interviews with contemporary witnesses. RESULTS: In the GDR, these women were compulsorily treated by physicians without sufficient information about the disease, diagnostics, and therapy. If the women refused medical care, they were coerced into it by the physicians. Medical care and research were inseparable. Without the knowledge of the women and without their consent, research was carried out on the blood samples and liver biopsies acquired from them.After the German reunification, the same physicians continued to conduct research on the same group of patients. Beginning in 1990, interferon therapy was offered to the women. Parallel to the medication with interferon, studies on the effects of the therapy were carried out. In this case as well, the women were not informed about the use of collected data, nor did they agree to it. CONCLUSIONS: Physicians should clearly define the border between medical care and scientific interest. Exclusively, data obtained from studies performed correctly under ethical point of view should be accepted for publication.


Assuntos
Contaminação de Medicamentos , Hepatite C Crônica/tratamento farmacológico , Imunoglobulina rho(D)/efeitos adversos , Assistência à Saúde , Feminino , Alemanha Oriental , Hepatite C Crônica/virologia , Experimentação Humana , Humanos , Consentimento Livre e Esclarecido
4.
Artigo em Inglês | MEDLINE | ID: mdl-31613718

RESUMO

A procedure was established and fully validated for the screening and quantification of fourteen synthetic antidiabetic adulterants in herbal pharmaceuticals and health foods, including metformin (MF), buformin (BF), phenformin (PHF), rosiglitazone (RGZ), pioglitazone (PGZ), chlorpropamide (CPM), glipizide (GPZ), tolbutamide (TBM), gliclazide (GCZ), glibenclamide (GBM), glimepiride (GMR), repaglinide (RGN), gliquidone (GQD) and nateglinide (NGN). The samples were extracted by methanol and separated by HPLC. Retention times and ultraviolet spectra were used for the preliminary screening, and the suspected adulterants were then confirmed by liquid chromatography-quadrupole-time of flight mass spectrometry (LC-Q-TOF-MS/MS) and quantified by HPLC. The developed procedure was successfully applied to assess twenty-four herbal samples, and PHF, GCZ, GBM, MF, GPZ and BF were found in many. To the best of our knowledge, this is the first report of simultaneous screening and quantification of these fourteen synthetic antidiabetic adulterants from any matrix.


Assuntos
Análise de Alimentos , Contaminação de Alimentos/análise , Hipoglicemiantes/análise , Preparações Farmacêuticas/análise , Cromatografia Líquida , Composição de Medicamentos , Contaminação de Medicamentos , Humanos , Espectrometria de Massas em Tandem
5.
Biomed Chromatogr ; 34(1): e4719, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31634417

RESUMO

A quality by design (QbD) based high-resolution HPLC method is described for determination of impurities in apixaban (APX) in the tablet dosage form. Employing a simple and stability-indicating HPLC method, nine known impurities were quantified with good peak resolution. Mobile phase A (MP-A) was prepared with buffer and acetonitrile 90:10 v/v, while mobile phase B (MP-B) contained water and acetonitrile 10:90 v/v. The gradient program was 0 min, MP-A 75%, B 25%; 20 min, MP-A 65%, B 35%; 30 min, MP-A 40%, B 60%; 40min, MP-A 40%, B 60%; 42 min, MP-A 75%, B 25%; and 50 min, MP-A 75%, B 25%. The chromatographic separation was achieved using a Zorbax RX C18 250 × 4.6 mm column, 5 µm (1.0 ml min-1 , 280 nm, 50 µl) and a column temperature of 40°C. Several separation studies were carried out using design of experiments to optimize the method. Validation results confirm the applicability of the developed method for quality analysis and stability studies of the regular product on the manufacturing stream.


Assuntos
Cromatografia Líquida de Alta Pressão/métodos , Cromatografia de Fase Reversa/métodos , Contaminação de Medicamentos , Pirazóis/análise , Pirazóis/química , Piridonas/análise , Piridonas/química , Estabilidade de Medicamentos , Limite de Detecção , Modelos Lineares , Reprodutibilidade dos Testes , Comprimidos
6.
Toxicol Lett ; 319: 237-241, 2020 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-31738974

RESUMO

The RSDL® (Reactive Skin Decontamination Lotion) Kit contains a lotion-impregnated sponge extensively studied for the removal or neutralization of chemical warfare agents from skin. Pilot investigation of efficacy with industrial threat compounds noted that synthetic opioid fentanyl citrate was removed by the RSDL Kit but not chemically inactivated by the lotion. This implies that after use the RSDL Kit will contain intact fentanyl, which may pose a dermal health hazard if the fentanyl is then transferred to skin after use without proper handling. This in vitro investigation studied the contaminated RSDL Kit using three different concentrations of fentanyl with a skin contact time of 15 min under direct interaction from passive contact, light touch, and leaning with one hand. It was demonstrated that the expected transfer of fentanyl from contaminated RSDL depends on 1) the concentration of fentanyl and 2) the area of the exposed surface. From a toxicological perspective, the contact risk of fentanyl under the conditions tested can be considered low but not absent. The present study determined that a contaminated RSDL Kit, used for removal of fentanyl, should be handled with proper care. Use of protective gloves in operational use and washing skin afterwards is advised to prevent undesired contamination.


Assuntos
Analgésicos Opioides/efeitos adversos , Analgésicos Opioides/análise , Contaminação de Medicamentos , Fentanila/efeitos adversos , Fentanila/análise , Creme para a Pele/efeitos adversos , Creme para a Pele/análise , Animais , Substâncias para a Guerra Química/química , Técnicas In Vitro , Projetos Piloto , Medição de Risco , Absorção Cutânea , Suínos
7.
Biomed Chromatogr ; 34(1): e4698, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31762077

RESUMO

BACKGROUND: Dietary supplements (DS) containing undeclared substances may pose serious risk to s public health. The consumers of DS should be aware of such products in order to avoid the risk of fatal outcomes. AIM OF THE STUDY: The study is based on the determination and identification of undeclared substances - theobromine (TB), theophylline (TH), pseudoephedrine (PE), caffeine (C), hydrochlorothiazide (HTZ) and yohimbine (Y) - in market-available DS. MATERIAL AND METHODS: Ultra-high-performance liquid chromatography with diode array detection (UHPLC-DAD) was utilized to identify and quantify the presence of undeclared substances, in 52 different DS collected from the market. RESULTS: A fast and reliable UHPLC-DAD method was developed and validated for simultaneous determination of the analyte where an efficient separation was achieved within 7 min runtime (TB 1.47, TH 1.79, PE 2.08, C 2.26, HTZ 3.78, Y 6.50) with resolution >1.5. The method validation produced r2 values ranging from 0.975 to 0.999 within a linearity range of 1-300 ppm. The UHPLC method revealed the presence of undeclared substances in 11 samples (HD3, HD4, HD9, HD13, HD14, HD15, HD21, HD24, HD27, HD38 and HD40), where the most widely distributed analyte was PE and C. The analyte found to have the highes concentrations (mg) in these DS were PE (11) and C (2.01). Among the 52 DS products tested, the product HD3 revealed a greater number and amount (mg) of undeclared substances, i.e. TH (0.05), C (2.01), HTZ (0.37) and Y (0.05), followed by HD14, i.e. PE (9.31), C (0.40), HTZ (0.01) and HD9 PE (11.00), C (0.41). CONCLUSION: The abundance of undeclared substances in these DS products was PE > C > Y > HTZ. None of the DS contained TB whereas TH was present in only one sample.


Assuntos
Fármacos Antiobesidade/análise , Cromatografia Líquida de Alta Pressão/métodos , Suplementos Nutricionais/análise , Fármacos Antiobesidade/normas , Suplementos Nutricionais/normas , Contaminação de Medicamentos/prevenção & controle , Limite de Detecção , Modelos Lineares , Análise de Componente Principal , Reprodutibilidade dos Testes , Arábia Saudita
8.
J Oncol Pharm Pract ; 26(1): 141-145, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31132937

RESUMO

INTRODUCTION: All guidelines necessitate wearing personal protective equipment during dispensing of oral anticancer drugs. This study aims to measure the degree of contamination on the press-through-package strips of oral anticancer drugs in Japan. METHOD: Surface contamination of the external packaging of anticancer drugs was examined by performing wipe tests at four hospitals and two community pharmacies. The following commercially available drugs were examined: Xeloda®, TS-1®, and methotrexate tablets and SA-1® and Rheumatrex® capsules. RESULTS: The wipe tests' results revealed that the contamination levels of Xeloda® and TS-1® tablets and SA-1® capsules were within their detection limits. In some facilities, the contamination levels on the press-through-package strips of Rheumatrex® capsules were 3.27 × 10-1, which is close to its detection limit. However, across all facilities, the contamination level of methotrexate tablets was above its detection limit. CONCLUSION: The results of this study suggested that adherence to oral anticancer drugs may not occur during manufacture or transportation. However, it may be due to the presence of pollutants in the facilities. Prevention of pollution in facilities might eliminate the need to wear personal protective equipment during dispensing of oral anticancer drugs.


Assuntos
Antineoplásicos/administração & dosagem , Contaminação de Medicamentos/prevenção & controle , Embalagem de Medicamentos/métodos , Contaminação de Equipamentos/prevenção & controle , Exposição Ocupacional/prevenção & controle , Antineoplásicos/análise , Embalagem de Medicamentos/normas , Monitoramento Ambiental/métodos , Monitoramento Ambiental/normas , Humanos , Japão/epidemiologia , Exposição Ocupacional/normas , Farmácias/normas
9.
J Pharm Biomed Anal ; 177: 112821, 2020 Jan 05.
Artigo em Inglês | MEDLINE | ID: mdl-31491660

RESUMO

Two high performance chromatographic methods were developed and validated for the simultaneous determination of Ambroxol, Guaifenesin and Theophylline in pharmaceutical dosage forms and in the presence of Guaiacol and Caffeine as the officially stated impurities. These were a reversed phase liquid and a thin layer chromatographic methods. The liquid chromatographic separation was achieved using Inertsil ODS-3 C18 column (4.6 mm × 250 mm, 5 µm). Gradient elution was performed using a mixture of solvent A (0.05 M ammonium acetate, pH 3, adjusted with glacial acetic acid) and solvent B (methanol), at a flow rate of 1.0 mL/min. The separated peaks were detected at 260.0 nm. The thin layer chromatography was performed using HPTLC 60 F254 silica gel plates, mobile phase was consisting of ethyl acetate: methanol: acetic acid (10:0.5:1, v/v/v) and detection was performed at 254.0 nm. Validation of the developed methods was achieved according to International Conference on Harmonization (ICH) guidelines. The proposed methods were fast, accurate, precise, and sensitive. Hence, they could be employed for routine quality control of the ternary mixture in capsule and syrup dosage forms.


Assuntos
Contaminação de Medicamentos/prevenção & controle , Controle de Qualidade , Fármacos do Sistema Respiratório/análise , Ambroxol/análise , Ambroxol/química , Cafeína/análise , Cápsulas , Cromatografia Líquida de Alta Pressão/métodos , Combinação de Medicamentos , Guaiacol/análise , Indóis/análise , Indóis/química , Limite de Detecção , Quinolizinas/análise , Quinolizinas/química , Reprodutibilidade dos Testes , Fármacos do Sistema Respiratório/química , Fármacos do Sistema Respiratório/normas , Teofilina/análise , Teofilina/química
10.
J Pharm Biomed Anal ; 177: 112851, 2020 Jan 05.
Artigo em Inglês | MEDLINE | ID: mdl-31499427

RESUMO

A high performance liquid chromatographic method was developed for the simultaneous determination of the related substances (R-ivabradine, dehydro-S-ivabradine, N-demethyl-S-ivabradine, ((S)-3,4-dimethoxy-bicyclo[4.2.0]octa-1,3,5-triene-7-yl-methyl)-methyl-amine) and 1-(7,8-dimethoxy-1,3,4,5-tetrahydro-2H-3-benzazepine-2-on-3-yl)-3-chloro-propane) of the heart-rate lowering drug, ivabradine. The separation capability of seven different polysaccharide-type chiral columns (Lux Amylose-1, Lux i-Amylose-1, Lux Amylose-2, Lux Cellulose-1, Lux Cellulose-2, Lux Cellulose-3 and Lux Cellulose-4) was investigated with a mobile phase consisting of 0.1% diethylamine in methanol, 2-propanol and acetonitrile. During the screnning experiments the best results were obtained on Lux Cellulose-2 (based on cellulose tris(3-chloro-4-methylphenylcarbamate) column with methanol with an ideal case, where all the impurities eluted before the S-ivabradine peak. Chromatographic parameters (flow rate, temperature and mobile phase constituents) were optimized by a full factorial screening design. Using optimized parameters (Lux Cellulose-2 column with 0.06% (v/v) diethylamine in methanol/acetonitrile 98/2 (v/v) with 0.45 mL/min flow rate at 12 °C) baseline separations were achieved between all compounds. The optimized method was validated according to the International Council on Harmonization Q2(R1) guideline and proved to be reliable, linear, precise and accurate for determination of at least 0.05% for all impurities in S-ivabradine samples. Method application was tested on a commercial tablet formulation and proved to be suitable for routine quality control of both chiral and achiral related substances of S-ivabradine.


Assuntos
Composição de Medicamentos/normas , Contaminação de Medicamentos/prevenção & controle , Ivabradina/análise , Controle de Qualidade , Celulose/análogos & derivados , Celulose/química , Química Farmacêutica , Cromatografia Líquida de Alta Pressão/instrumentação , Ivabradina/química , Fenilcarbamatos/química , Estereoisomerismo , Comprimidos , Temperatura
11.
J Pharm Biomed Anal ; 177: 112895, 2020 Jan 05.
Artigo em Inglês | MEDLINE | ID: mdl-31580988

RESUMO

A flower-like gold nanoparticles (FGN)-based immunochromatographic test strip (ICS) was developed and used for the first time for the rapid simultaneous detection of fumonisin B1 (FB1) and deoxynivalenol (DON) in Chinese traditional medicine. Several experimental conditions affecting the sensitivity of ICS have been investigated, including the type of FGN, the preparation conditions of FGN-monoclonal antibody (MAb) conjugates, and the process parameters of ICS. Under the optimal experimental conditions, the visual limit of detection was 5.0 ng/mL (corresponding to 50 µg/kg in Chinese traditional medicine samples) for both FB1 and DON, and detection can be completed within 5 min. In addition, the natural samples were analyzed using high-performance liquid chromatography (HPLC) or enzyme-linked immunosorbent assay (ELISA), and the results of these methods showed good correlation with those obtained using ICS. The procedure using FGN-based simultaneous ICS was sensitive, rapid, and convenient for on-site detection of a large number of samples.


Assuntos
Carcinógenos Ambientais/análise , Cromatografia de Afinidade/instrumentação , Contaminação de Medicamentos/prevenção & controle , Medicamentos de Ervas Chinesas/análise , Nanopartículas Metálicas/química , Medicamentos de Ervas Chinesas/química , Medicamentos de Ervas Chinesas/normas , Fumonisinas/análise , Ouro/química , Limite de Detecção , Tricotecenos/análise
12.
J Pharm Biomed Anal ; 177: 112887, 2020 Jan 05.
Artigo em Inglês | MEDLINE | ID: mdl-31580989

RESUMO

In the present study we report a fully automated method for the determination of low levels of the genotoxic impurity hydrazine in allopurinol active pharmaceutical ingredient (API) and formulations based on the concept of zone-fluidics. Hydrazine reacts on-line with o-phthalaldehyde in a unique way, that is in acidic medium (pH < 1.5) and in the absence of nucleophilic reagents, to form a highly fluorescent hydrazone (λex/em = 318 / 376 nm). The adaptation of a 120 s long stopped-flow step at elevated temperature (70 °C) offered adequate sensitivity (LOD =0.9 µg L-1 or 0.1 ppm in the solid API) to meet the pharmacopoeia limits for the selected application. The analyte was separated efficiently from the excess of the API by on line solid phase extraction using a Hydrophilic-Lipophilic technology sorbent that provided direct retention of the more hydrophobic API without the need of wetting/conditioning steps. Percent recoveries ranged between 93.3 and 105.8%.


Assuntos
Alopurinol/análise , Carcinógenos/análise , Contaminação de Medicamentos/prevenção & controle , Hidrazinas/análise , Extração em Fase Sólida/métodos , Cromatografia Líquida de Alta Pressão/métodos , Eletrodos , Fluorometria/instrumentação , Fluorometria/métodos , Temperatura Alta , Interações Hidrofóbicas e Hidrofílicas , Limite de Detecção , Extração em Fase Sólida/instrumentação
13.
J Pharm Biomed Anal ; 177: 112808, 2020 Jan 05.
Artigo em Inglês | MEDLINE | ID: mdl-31585328

RESUMO

Consulting the national pharmacopoeia, no official quality standard was found for estimation of related substances and assay of atosiban acetate injection, of which main active component is atosiban. To solve this problem, herein, a novel high performance liquid chromatographic (HPLC) method was developed and validated in this study. A chromatographic system comprising an Inertsil ODS-2 analytical column, mobile phase-A of water (pH adjusted to 3.2 with trifluoroacetic acid)-acetonitrile-methanol (77:14:9, v/v/v), mobile phase-B of acetonitrile-methanol (65:35, v/v), a flow rate of 1.0 mL min-1 and a UV detector set at 220 nm with column temperature at 35 °C has shown simple, reproducible and specific determination for atosiban and its five related substances. Also, we combined with mass spectrometry to characterize the molecular weight and tentative structure of the impurities. Using HPLC verified methodology, results of the validation study showed that the precision, specificity and accuracy of the five impurities, good linear equation R squared was greater than 0.9993, and as such, the limit of detection and the limit of quantification have been determined. The proposed method in this study, which, to the best of our knowledge, is the most comprehensive HPLC determination applied to the routine analysis in quality control of this injection.


Assuntos
Contaminação de Medicamentos/prevenção & controle , Controle de Qualidade , Tocolíticos/análise , Vasotocina/análogos & derivados , Cromatografia Líquida de Alta Pressão/métodos , Injeções , Limite de Detecção , Reprodutibilidade dos Testes , Tocolíticos/administração & dosagem , Tocolíticos/normas , Vasotocina/administração & dosagem , Vasotocina/análise
15.
J. optom. (Internet) ; 12(4): 263-271, oct.-dic. 2019. mapas, graf, tab
Artigo em Inglês | IBECS | ID: ibc-188256

RESUMO

PURPOSE: To determine the microbial contaminants and its clinical importance in topical diagnostic ophthalmic medications (cycloplegics/mydriatics and miotics) in eye clinics in Ghana. Method: A cross-section of eye clinics was sampled for the diagnostic agents (Atropine, Phenylephrine, Tropicamide and Cyclopentolate, Pilocarpine). Standard laboratory procedures and protocols were observed in culturing the samples on different Agars. Microscopy and various biochemical tests were performed to identify microbial species. Antimicrobial susceptibility testing was also performed to ascertain the clinical importance of the isolated microbes. RESULTS: A total of 113 samples were obtained, from which 334 bacteria were isolated which included Bacilli spp. 91(27.25%), Coagulase Negative Staphylococci spp. 59(17.66%), Moraxella spp. 47(14.07%), Staphylococcus aureus 41(12.27%), Streptococcus spp. 21(6.29%), Klebsiella spp. 20(5.99%), Pseudomonas spp. 13(3.89%), Proteus spp. 12(3.59%), Escherichia coli. 12 (3.59%), Serratia spp. 10(2.99%), Shigella spp. 7(2.09%), Salmonella spp. 1(0.3%). There were 96 isolated fungal contaminants mainly Penicillium spp. 41(42.71%), Cephalosporium spp. 19(19.79%), Cladosporium spp. 15(15.63%), Aspergillus spp. 13(13.54%), Cercospora spp. 8(8.33%). The diagnostic agent with the most bacteria contamination was Phenylephrine 90 (26.95%) and the least being Pilocarpine 49 (14.67%). Also, the diagnostic agent with the most fungal contamination was Cyclopentolate 29 (30.2%) and the least was Tropicamide and Pilocarpine with 15 (15.63%) each. Gentamicin and Ciprofloxacin were the only antibiotics that showed 100% activity against all the bacterial isolates. Fungal contaminants were more susceptible to Ketoconazole as compared to Fluconazole. Conclusion: Topical diagnostic ophthalmic preparations used in clinical settings in Ghana are contaminated with clinically important bacteria and fungi


OBJETIVO: Determinar los contaminantes microbianos y su importancia clínica en los fármacos oftálmicos diagnósticos tópicos (ciclopléjicos/midriáticos y mióticos) en clínicas oftalmológicas de Gana. MÉTODO: Se realizó una muestra transversal de clínicas oftalmológicas para los agentes diagnósticos (Atropina, Fenilefrina, Tropicamida y Ciclopentolato, Pilocarpina). Se observaron procedimientos y protocolos de laboratorio estándar en cuanto al cultivo de muestras en diferentes soluciones de Agar. Se realizaron diversas pruebas microscópicas y bioquímicas para identificar las especies microbianas. También se realizó la prueba de susceptibilidad antimicrobiana para comprobar la importancia clínica de los microbios aislados. RESULTADOS: Se obtuvieron un total de 113 muestras, de las cuales se aislaron 334 bacterias que incluyeron Bacilli spp. 91(27,25%), Staphylococci spp. Coagulasa negativos 59(17,66%), Moraxella spp. 47(14,07%), Staphylococcus aureus 41(12,27%), Streptococcus spp. 21(6,29%), Klebsiella spp. 20(5,99%), Pseudomonas spp. 13(3,89%), Proteus spp. 12(3,59%), Escherichia coli. 12(3,59%), Serratia spp. 10(2,99%), Shigella spp. 7(2,09%), Salmonella spp. 1(0,3%). Se encontraron 96 contaminantes fúngicos aislados, principalmente Penicillium spp. 41 (42,71%), Cephalosporium spp. 19 (19,79%), Cladosporium spp. 15 (15,63%), Aspergillus spp. 13 (13,54%), Cercospora spp. 8 (8,33%). El agente diagnóstico con mayor contaminación bacteriana fue Fenilefrina 90(26,95%), siendo Pilocarpina 49 (14,67%) el que reflejó una menor contaminación bacteriana. De igual modo, el agente diagnóstico con mayor contaminación fúngica fue Ciclopentolato 29 (30,2%), siendo Tropicamida y Pilocarpina, con 15 (15.63%) cada uno, los que reflejaron menos contaminación fúngica. Gentamicina y Ciprofloxacina fueron los únicos antibióticos que reflejaron un 100% de actividad frente a todos los aislados bacterianos. Los contaminantes fúngicos fueron más susceptibles a Ketoconazol, en comparación con Fluconazol. CONCLUSIÓN: Los preparados oftálmicos diagnósticos tópicos en entornos clínicos en Gana están contaminados por bacterias y hongos clínicamente importantes


Assuntos
Humanos , Bactérias/isolamento & purificação , Contaminação de Medicamentos/estatística & dados numéricos , Mióticos/análise , Midriáticos/análise , Administração Oftálmica , Técnicas Bacteriológicas , Estudos Transversais , Gana , Testes de Sensibilidade Microbiana , Soluções Oftálmicas
16.
BMC Pharmacol Toxicol ; 20(Suppl 1): 82, 2019 12 19.
Artigo em Inglês | MEDLINE | ID: mdl-31852534

RESUMO

BACKGROUND: The presence of impurities in some drugs may compromise the safety and efficacy of the patient's treatment. Therefore, establishing of the biological safety of the impurities is essential. Diabetic patients are predisposed to tissue damage due to an increased oxidative stress process; and drug impurities may contribute to these toxic effects. In this context, the aim of this work was to study the toxicity, in 3 T3 cells, of the antidiabetic agents sitagliptin, vildagliptin, and their two main impurities of synthesis (S1 and S2; V1 and V2, respectively). METHODS: MTT reduction and neutral red uptake assays were performed in cytotoxicity tests. In addition, DNA damage (measured by comet assay), intracellular free radicals (by DCF), NO production, and mitochondrial membrane potential (ΔψM) were evaluated. RESULTS: Cytotoxicity was observed for impurity V2. Free radicals generation was found at 1000 µM of sitagliptin and 10 µM of both vildagliptin impurities (V1 and V2). A decrease in NO production was observed for all vildagliptin concentrations. No alterations were observed in ΔψM or DNA damage at the tested concentrations. CONCLUSIONS: This study demonstrated that the presence of impurities might increase the cytotoxicity and oxidative stress of the pharmaceutical formulations at the concentrations studied.


Assuntos
Composição de Medicamentos/normas , Contaminação de Medicamentos , Fibroblastos/efeitos dos fármacos , Hipoglicemiantes/toxicidade , Fosfato de Sitagliptina/toxicidade , Vildagliptina/toxicidade , Células 3T3 , Animais , Sobrevivência Celular/efeitos dos fármacos , Dano ao DNA , Fibroblastos/metabolismo , Fibroblastos/patologia , Hipoglicemiantes/química , Potencial da Membrana Mitocondrial/efeitos dos fármacos , Camundongos , Óxido Nítrico/metabolismo , Espécies Reativas de Oxigênio/metabolismo , Fosfato de Sitagliptina/química , Vildagliptina/química
18.
Crit Rev Toxicol ; 49(7): 567-579, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31854211

RESUMO

Botanicals and botanical preparations including plant food supplements as well as medicinal herbal supplements can contain possible beneficial health compounds, but also ingredients of concern. Compounds that are both genotoxic and carcinogenic have been found in herbal supplements and may raise a safety concern. Genotoxic carcinogens that can be present in botanicals and botanical preprations include especially pyrrolizidine alkaloids (PAs), aristolochic acids (AAs) and alkenylbenzenes (ABs). The present manuscript provides an overview of the levels of these compounds reported to date to be present in herbal supplements with an associated risk assessment. Exposure was estimated based on levels of PAs, AAs and ABs in individual supplements and their proposed uses. In addition a probabilistic exposure assessment was performed based on the distribution of the level of the compounds of concern in the food supplements and of the recommended uses, resulting in 5th to 95th percentile consumer exposure values. To evaluate the risk of these exposures, the margin of exposure (MOE) approach for lifetime exposure was used. To correct exposure estimates for shorter than lifetime exposure, Haber's rule as a first tier approach was applied. It is concluded that the proposed uses and use levels as well as the presence of AAs, ABs and PAs in food supplements should be carefully monitored to manage potential consumer risks. More information on estimated daily intake resulting from supplement use, as well as consequences of concomitant exposure will further improve the risk evaluation of products containing these compounds of concern.


Assuntos
Suplementos Nutricionais/efeitos adversos , Contaminação de Medicamentos , Carcinógenos/toxicidade , Humanos , Medição de Risco
19.
Pediatrics ; 144(6)2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31767714

RESUMO

Aluminum has no known biological function; however, it is a contaminant present in most foods and medications. Aluminum is excreted by the renal system, and patients with renal diseases should avoid aluminum-containing medications. Studies demonstrating long-term toxicity from the aluminum content in parenteral nutrition components led the US Food and Drug Administration to implement rules for these solutions. Large-volume ingredients were required to reduce the aluminum concentration, and small-volume components were required to be labeled with the aluminum concentration. Despite these rules, the total aluminum concentration from some components continues to be above the recommended final concentration. The concerns about toxicity from the aluminum present in infant formulas and antiperspirants have not been substantiated but require more research. Aluminum is one of the most effective adjuvants used in vaccines, and a large number of studies have documented minimal adverse effects from this use. Long-term, high-concentration exposure to aluminum has been linked in meta-analyses with the development of Alzheimer disease.


Assuntos
Alumínio/efeitos adversos , Soluções/química , Adjuvantes Farmacêuticos/química , Alumínio/análise , Alumínio/farmacocinética , Doença de Alzheimer , Antiperspirantes/química , Criança , Soluções para Diálise/química , Contaminação de Medicamentos/legislação & jurisprudência , Rotulagem de Medicamentos/legislação & jurisprudência , Regulamentação Governamental , Humanos , Lactente , Fórmulas Infantis/química , Recém-Nascido , Recém-Nascido Prematuro , Rim/metabolismo , Nefropatias/metabolismo , Nutrição Parenteral , Soluções/normas , Estados Unidos , United States Food and Drug Administration , Vacinas/química
20.
Clin Ter ; 170(6): e425-e426, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31696904

RESUMO

The practice of drug of abuse adulteration is changing. Currently, the risk of new adulteration practices involves New Psychoactive Substances (NPS), which can also be used as adulterants. In particular, the phenomenon of adulteration concerns fentanyl and its analogs, substances that can be toxic even if taken in very small quantities. The adulteration that involves NPS is creating a serious threat to the health of drug users, not only because of the pharmacological action but because of the increased toxicity of these new cutting agents.


Assuntos
Contaminação de Medicamentos , Psicotrópicos/efeitos adversos , Usuários de Drogas , Fentanila/efeitos adversos , Humanos
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