Biopharmaceutics classification system: importance and inclusion in biowaiver guidance

O tratamento farmacológico é essencial frente a várias patologias e é fundamental que a política de medicamentos tenha por objetivo oferecer à população tratamento seguro, eficaz e de preço acessível. Uma forma de alcançar esse objetivo é por meio da bioisenção, definida como a substituição de estudos de bioequivalência in vivo por estudos in vitro. Para bioisentar novos medicamentos sob a forma farmacêutica sólida oral de liberação imediata são utilizados dados de permeabilidade intestinal e solubilidade do fármaco, bem como sua dissolução a partir da forma farmacêutica. O Sistema de Classificação Biofarmacêutica (SCB) é um esquema científico que divide os fármacos em classes de acordo com a solubilidade e permeabilidade e vem sendo utilizado como critério para bioisenção em diversas legislações. O presente artigo faz uma avaliação da aplicação da bioisenção, abordando os conceitos gerais e parâmetros utilizados pelo SCB, fazendo um relato histórico da aplicação da bioisenção, das exigências pertinentes às legislações vigentes, dos benefícios e riscos inerentes a uma tomada de decisão sobre bioisenção baseada neste critério. Os resultados revelaram que a utilização do SCB como critério amplia enormemente as possibilidades de bioisenção, contribuindo para o maior acesso da população em geral a medicamentos com garantida eficácia, segurança e menor custo.Pharmacological therapy is essential in many diseases treatment and it is important that the medicine policy is intended to offering safe and effective treatment with affordable price to the population. One way to achieve this is through biowaiver, defined as the replacement of in vivo bioequivalence studies by in vitro studies. For biowaiver of new immediate release solid oral dosage forms, data such as intestinal permeability and solubility of the drug are required, as well as the product dissolution. The Biopharmaceutics Classification System (BCS) is a scientific scheme that divides drugs according to their solubility and permeability and has been used by various guides as a criterion for biowaiver. This paper evaluates biowaiver application, addressing the general concepts and parameters used by BCS, making a historical account of its use, the requirements pertaining to the current legislation, the benefits and risks associated with this decision. The results revealed that the use of BCS as a biowaiver criterion greatly expands the therapeutics options, contributing to greater therapy access of the general population with drug efficacy and safety guaranteed associated to low cost

Effects of pre-filmed FeCO3 on flow-induced corrosion and erosion-corrosion in the absence and presence of corrosion inhibitor at 60 °C

In CO2 environments, an increase in the temperature can influence carbon steel flow-induced corrosion (FIC) and erosion-corrosion (EC) degradation processes. Increasing temperature typically results in the acceleration of electrochemical degradation mechanisms in the absence of protective corrosion product layers. Furthermore, the presence of sand in corrosive process fluids could aggravate the service conditions. Although protective iron carbonate (FeCO3) film or/and corrosion inhibitors are capable of suppressing corrosion in CO2-containing environments typical of oil and gas production, their ability to suppress degradation and their associated mechanisms in erosion-corrosion environments is less understood. This work focuses on understanding the ability of FeCO3 to protect the steel surface in the absence and presence of corrosion inhibitor and their interactions in flow-induced and erosion-corrosion systems at 60 °C. The effect of the temperature increase is investigated based on results obtained in a previous study performed at 25 °C. FeCO3 filmed carbon steel specimens were developed using an autoclave at 60 °C, pH 6.6 and 30 bar in a 1.5 wt% NaCl CO2-saturated solution over 48 h. The FeCO3 covered specimens were evaluated in FIC and EC environments at 60 °C and a flow velocity of 15 m/s in the presence and absence of 1000 mg/L sand and 100 ppm of a commercially available corrosion inhibitor. Results indicate that the sole presence of an FeCO3 layer is not sufficient to retard the corrosive process of carbon steel at 60 °C under EC conditions. However, the commercial corrosion inhibitor was observed to worked synergistically with the FeCO3 layer to reduce the corrosion degradation component in both the presence and absence of sand particles. The erosion component is also reduced in erosion-corrosion environments as a result of the combined presence of FeCO3 and corrosion inhibitor

Risk stratification for small for gestational age for the Brazilian population: a secondary analysis of the Birth in Brazil study.

Risk-stratification screening for SGA has been proposed in high-income countries to prevent perinatal morbidity and mortality. There is paucity of data from middle-income settings. The aim of this study is to explore risk factors for SGA in Brazil and assess potential for risk stratification. This population-based study is a secondary analysis of Birth in Brazil study, conducted in 266 maternity units between 2011 and 2012. Univariate and multivariate logistic regressions were performed, and population attributable fraction estimated for early and all pregnancy factors. We calculated absolute risk, odds ratio, and population prevalence of single or combined factors stratified by parity. Factors associated with SGA were maternal lupus (ORadj 4.36, 95% CI [2.32-8.18]), hypertensive disorders in pregnancy (ORadj 2.72, 95% CI [2.28-3.24]), weight gain < 5 kg (ORadj 2.37, 95% CI [1.99-2.83]), smoking at late pregnancy (ORadj 2.04, 95% CI [1.60-2.59]), previous low birthweight (ORadj 2.22, 95% CI [1.79-2.75]), nulliparity (ORadj 1.81, 95% CI [1.60-2.05]), underweight (ORadj 1.61, 95% CI [1.36-1.92]) and socioeconomic status (SES) < 5th centile (ORadj 1.23, 95% CI [1.05-1.45]). Having two or more risk factors (prevalence of 4.4% and 8.0%) was associated with a 2 and fourfold increase in the risk for SGA in nulliparous and multiparous, respectively. Early and all pregnancy risk factors allow development of risk-stratification for SGA. Implementation of risk stratification coupled with specific strategies for reduction of risk and increased surveillance has the potential to contribute to the reduction of stillbirth in Brazil through increased detection of SGA, appropriate management and timely delivery

Discomfort experienced at the daily life of relatives of people admitted at ICU

This is a qualitative research that aimed to get to know the discomforts experienced at the daily life of relatives of people admitted at the intensive care unit (ICU). It happened on a general ICU at a public hospital, in Salvador-BA, by the second half of 2009. Nine relatives of people admitted were interviewed. The technique used was the analysis from the Grounded Theory. The results showed that the interaction of the families with the reality of life threat from the relative admitted, had as main discomfort, the discontinuity in their daily life, which was characterized by four categories: Living the distress of a possible loss, difficulties to take care of themselves, facing a separation in the family, suffering with changes in their social and professional lives. These discomforts can be minimized by the healthcare team’s effectiveness to the demands of the family and the support of its social network