Development and validation of a microbial counting method for mebendazole oral suspension

Mebendazole is an important medicine used to treat helminth infections. These infections affect more than two billion people worldwide. The LAFEPE® (Recife-PE, Brazil) produces the drug mebendazole oral suspension that contains the preservatives methylparaben and propylparaben in its formulation. Drugs that have antimicrobial properties due to preservatives must undergo neutralization of these compounds to allow microbial count testing according to recommendations by the official compendia. In order to obtain a validated method for microbial counting and to ensure its safety and reliability within the pharmaceutical industry, validation of preservative neutralization and of the method for microbial counting was performed according to the USP 30 and PDA Technical Report No. 33. The method used ATCC Gram positive and Gram negative microorganisms, yeasts, most and culture media Tryptic Soy Agar and Sabouraud dextrose agar. The neutralizers were polysorbate 80 and lecithin. Recovery levels of over 70% of the microorganisms used in the test indicated the neutralization of antimicrobial activity and proved the absence of toxicity of neutralizers. The microbial counting method validated proved accurate, precise, robust and linear and can be safely used in routine operations.O mebendazol é um importante medicamento utilizado no tratamento de infecções por helmintos. Essas infecções afetam mais de dois bilhões de pessoas em todo o mundo. O LAFEPE (Recife-PE, Brasil) produz o medicamento mebendazol suspensão oral, que possui em sua formulação os conservantes metilparabeno e propilparabeno. Em medicamentos que possuem propriedades antimicrobianas em decorrência dos conservantes faz-se necessária a neutralização da ação desses compostos para a realização do teste de contagem microbiana segundo preconizado pelos compêndios oficiais. A fim de obter um método de contagem microbiana validado e que garanta sua segurança e reprodutibilidade dentro da indústria farmacêutica foi realizada a validação da neutralização dos antimicrobianos e validação do método de contagem microbiana de acordo com a USP 30 e PDA-Technical Report N° 33. O método desenvolvido utilizou microrganismos ATCC Gram positivos, Gram negativos, leveduras e fungos e meios de cultura Tryptic Soy Agar e Sabouraud-dextrose Agar. Os neutralizantes foram polissorbato 80 e lecitina de soja . Níveis de recuperação superiores a 70% dos microrganismos utilizados no ensaio indicaram neutralização da atividade antimicrobiana e comprovou a ausência de toxicidade dos neutralizantes. O método de contagem microbiana validado revelou-se exato, preciso, robusto e linear podendo ser utilizado com segurança na rotina operacional

Recull de propostes per minimitzar l'impacte negatiu de gènere del sistema de teletreball a l'Ajuntament de Barcelona

Finançat amb el projecte "Impacto de GÉnero del TEletrabajo y rutinas de COnfinamiento: más allá de lo obvio" (Ref. SUPERACOVID19_2.2.IGETECO) i a través de l'Ajuntament de Barcelona pel Servei d'Estudi sobre propostes per minimitzar l'impacte negatiu de gènere del sistema de teletreball a l'Ajuntament de Barcelona (exp.20002682)El present document recull les propostes d'actuació contingues a l'estudi Propostes per minimitzar l'impacte negatiu de gènere del sistema de teletreball a l'Ajuntament de Barcelona realitzat pel Centre d'Estudis Sociològics sobre la Vida Quotidiana i el Treball (QUIT) de la Universitat Autònoma de Barcelona. L'emergència sanitària provocada per la Covid19 i el necessari confinament de la població per combatre la pandèmia ha significat, des del punt de vista de l'organització del treball, un canvi molt important cap a l'impuls de formes de treball a distància. Però aquest impuls del teletreball ha estat una resposta fruit de l'emergència, lògica davant la situació viscuda i, com a tal, no ha pogut ser planificada amb el temps i els mitjans necessaris

Polymorphism: an evaluation of the potential risk to the quality of drug products from the Farmácia Popular Rede Própria

Polymorphism in solids is a common phenomenon in drugs, which can lead to compromised quality due to changes in their physicochemical properties, particularly solubility, and, therefore, reduce bioavailability. Herein, a bibliographic survey was performed based on key issues and studies related to polymorphism in active pharmaceutical ingredient (APIs) present in medications from the Farmácia Popular Rede Própria. Polymorphism must be controlled to prevent possible ineffective therapy and/or improper dosage. Few mandatory tests for the identification and control of polymorphism in medications are currently available, which can result in serious public health concerns

Quantitative Structure-Pharmacokinetic Relationships: Artificial Neural Network Modeling

The technology and research revolution has provided many areas of science and industry with tools for more extensive and efficient operation. Nowhere is this phenomenon more evident than for new drug discovery and development in the pharmaceutical industry. Exploring the relationship between the structure of a molecule and its various biological and biochemical properties is the basis of drug discovery. Modern approaches to this field of study employ a combination of techniques. These include tests based on combinatorial chemistry and high-throughput (HT) screening as well as rational pharmaceutical design based on geometric and chemical characteristics of moleculemolecule interactions. Furthermore, understanding and optimising factors such as the effect of a compound on the body and the effect of the body on a compound are essential in developing a new drug. The main bottleneck in drug discovery is the identification of new chemical entities (NCEs) to be used for drug leads. The 1990s saw development of new automated tools for drug discovery including combinatorial chemistry and high-throughput screening. These tools have led to the increased discovery of new drug lead compounds each of which in tum require pharmacological and pharmacokinetic testing. Moreover, substantial increases in computing power as well as development of robust software has given scientists the opportunity to undertake significant research projects from their own desktops. Consequently, data analysis, data mining, and information manipulation have all benefited and progressed considerably. Software programs have been developed for a wide range of fields such as quantitative structureactivity relationship (QSAR) studies, pharmacophore elucidation, molecular modeling, drugreceptor interactions and in vivo simulations. Newer techniques have been influenced by what is termed "soft computing" which aims to accommodate the imprecision and uncertainty inherent in the real world [Zadeh, 1996]. Soft computing draws on the model of the human brain and derives mainly from artificial intelligence (Al) sources including genetic algorithm (GA), fuzzy logic, and artificial neural network (ANN) approaches [Maddalena, 1998]. Other less conunon techniques include cellular automata, fractals and chaos theory. ANNs are aparticularly useful modeling tools for nonlinear systems. Although not as common in the pharmaceutical industry as conventional modeling and mathematical techniques, soft computing has been successful in a number of fields in the industry