Cristiani Lopes Capistrano Gonçalves de Oliveira

People who suffer from calcium deficiency need supplementation to avoid diseases caused by low levels in the body, as this element performs several essential physiological functions in the human body. In this context, the present work aimed to validate a complexometric method for the determination of calcium carbonate in four different formulations, and the method validation followed the specifications of RDC 166/17 (ANVISA). The method proved to be selective, linear, accurate, precise and robust. The analytical curve showed a parametric and homoscedastic data distribution, with R2 > 0.99. In the analysis of precision and accuracy, relative standard deviation (RSD) values of less than 1.7% and recovery percentages above 98% were obtained, respectively, indicating that the method is precise and accurate. The application of the Youden method in the robustness study demonstrated the influence of the indicator on the methodology, while the other deliberate changes in the analytical method did not affect the response. In this way, a precise adjustment was made in the amount of the indicator to maintain the precision and accuracy of the methodology. The application of the validated classic method, as an environmentally friendly alternative, confirmed its potential for possible routine analysis applied to pharmaceutical forms in capsules.

Objectives The administration of solid drugs via enteral feeding tubes is a common practice in hospitals. However, there is a paucity of literature about the stability of the drug and its interaction with medical devices. This study evaluated the sorption and content of furosemide tablets when administered through an enteral feeding tube, simulating a hospital clinical protocol. Methods In the laboratory, a high-performance liquid chromatography method for evaluating furosemide in tablets was validated with the simulation of the hospital protocol involving dispersing furosemide tablets in 10 mL of bottled water using syringes. The content was evaluated before and after passage through enteral feeding tubes made of three different materials (polyvinyl chloride—PVC, polyurethane and silicone). The sorption of furosemide in the tubes was evaluated by infrared spectrophotometry. Results The developed analytical method demonstrated selectivity, linearity within the 30–60 µg/mL range, as well as precision and accuracy. The stability of the furosemide in the syringes was also assessed, and no significant decay in content or formation of degradation products was observed during the 180 min exposure before passing through the enteral feeding tube. The simulation demonstrated that the furosemide content remained stable after passing through PVC (100.90%), polyurethane (98.58%) and silicone (99.56%) tubes. Furthermore, no sorption of furosemide was detected in any of the materials. Conclusion These results confirm the safety and stability of the hospital’s protocol for administering furosemide via enteral feeding tube to the patient.

A farmácia universitária é um estabelecimento de saúde vinculado a uma instituição de ensino superior que se apresenta como cenário de práticas de ensino, pesquisa e extensão na área de farmácia e atua perante a comunidade, por meio da prestação de serviços farmacêuticos, como dispensação e manipulação de medicamentos e atenção farmacêutica, entre outros. O presente estudo buscou formular a gestão estratégica em uma farmácia universitária, com base na identificação de processos críticos e na construção de indicadores para o setor de dispensação de medicamentos. Trata-se de uma pesquisa aplicada que objetiva encontrar soluções para determinados problemas conforme conhecimentos já estabelecidos. A pesquisa teve a participação de sete farmacêuticos. Foi aplicado um questionário e realizado um grupo focal com a gestão e os farmacêuticos. Com base nos dados coletados, foram definidos, inicialmente, a missão, a visão, os valores e os objetivos estratégicos da farmácia universitária. Depois da análise dos processos e de posterior identificação de sistemas críticos, foram determinados sete indicadores baseados no método de gestão de desempenho Balanced Scorecard (BSC), que estão relacionados com a perspectiva financeira, os processos internos, os clientes e o aprendizado e crescimento. A implementação da gestão por processos e a formulação de indicadores baseados nos sistemas críticos são importantes para o aprimoramento da gestão organizacional da farmácia universitária.

Even with all the care taken during the production process, the pharmaceutical industries are still subject to manufacturing medicines with quality deviations, generating commercialized products without the required quality and necessitating their subsequent recall from the market. The objective of this study was to evaluate the reasons that led to the recall of medicines in Brazil in the period evaluated. This is a descriptive study (using document analysis), on the recall of substandard medicines registered on the website of the National Health Surveillance Agency (ANVISA), from 2010 to 2018. The variables studied were the type of medicine (reference, generic, similar, specific, biological, herbal, simplified notification, new and radiopharmaceutical), type of pharmaceutical dosage form (solid, liquid, semi-solid and parenteral preparation), and reason for recall (Good manufacturing practices, quality and quality/good manufacturing practices). A total of n = 3,056 recalls of substandard medicine were recorded. Similar medicines had a higher recall index (30.1%), followed by generics (21.3%), simplified notification (20.7%) and reference (12.2%). Different dosage forms had similar recalls: solids (35.2%), liquids (31.2%) and parenteral preparations (30.0%), with the exception of semi-solids (3.4%). The reasons for the highest occurrences were related to good manufacturing practices (58.4%) and quality (40.4%). The probable cause for this high number of recalls is the fact that, even with all the quality controls and processes in accordance with good manufacturing practices, errors can occur, both human and in automated processes, thus causing the release of batches that should not have been approved. In summary, it is necessary for manufacturers to implement a robust and well structured quality system in order to avoid such deviations, and it is up to ANVISA to apply greater oversight in the post marketing of these products.

Os anti-inflamatórios não esteroidais (AINEs) constituem um grupo terapêutico de interesse, pois têm propriedades analgésicas, antipiréticas e anti-inflamatórias, sendo uma das classes mais consumidas no mundo. No Brasil, os AINEs são facilmente encontrados em farmácias e alguns são comercializados sem a apresentação do receituário, sendo que o Ibuprofeno é o fármaco de primeira escolha entre os AINES. A qualidade e a intercambialidade de diferentes medicamentos é garantida pela comprovação da equivalência farmacêutica, bioequivalência, boas práticas de fabricação e controle de qualidade na indústria farmacêutica. O presente trabalho teve por objetivo realizar a equivalência farmacêutica e perfil de dissolução de comprimidos de ibuprofeno 600 mg (referência, genérico e similar) comercializados em Fortaleza, com o intuito de avaliar a qualidade dos medicamentos similares e genéricos em relação ao medicamento de referência. Para as análises foram utilizados o medicamento referência, um medicamento genérico e quatro similares. As análises realizadas foram determinação de peso, dureza, friabilidade, teste de desintegração, uniformidade de dose unitária, teste de dissolução, doseamento e testes de segurança biológica de acordo com a Farmacopeia Brasileira 6ª Edição, bem como o perfil de dissolução comparativo. Os comprimidos analisados estavam dentro da especificação para todos os testes físico-químicos e microbiológicos realizados. Contudo, em relação ao perfil de dissolução, somente um medicamento similar foi semelhante ao medicamento referência analisado nas condições de ensaio in vitro empregadas, sendo equivalente farmacêutico ao de referência. Palavras-chave: Ibuprofeno. Equivalência Farmacêutica. Controle de Qualidade. Medicamentos Genéricos. Abstract Non-steroidal anti-inflammatory drugs (NSAIDs) are a therapeutic group of interest, as they have analgesic, antipyretic and anti-inflammatory properties, being one of the most consumed classes in the world. In Brazil, NSAIDs are easily found in pharmacies and some are sold without prescriptions and Ibuprofen is the drug of first choice among NSAIDs. The quality and interchangeability of different drugs are guaranteed by proof of pharmaceutical equivalence, bioequivalence, good manufacturing practices and quality control in the pharmaceutical industry. This study aimed to carry out the pharmaceutical equivalence and dissolution profile of ibuprofen tablets 600 mg (reference, generic and similar) commercialized in Fortaleza, in order to assess the quality of similar and generic drugs in relation to the reference drug. For the analyses, the reference drug, a generic drug and four similar drugs were used. The analyzes performed were determination of weight, hardness, friability, disintegration test, uniformity of unit dose, dissolution test, dosage and biological safety tests according to the Brazilian Pharmacopoeia 6th Edition, as well as the comparative dissolution profile. The tablets analyzed were within the specification for all the physical-chemical and microbiological tests performed. However, in relation to the dissolution profile, only one similar drug was similar to the analyzed reference drug under the in vitro test conditions used, being pharmaceutical equivalent to the reference drug. Keywords: Ibuprofen. Pharmaceutical equivalence. Quality control. Generic Drugs.

What is known and objective Immunosuppression is the main goal in the treatment of autoimmune diseases, chronic inflammatory diseases, and solid organ and tissue transplantation. However, due to a lack of liquid‐form medications, it is challenging to achieve adequate immunosuppression when the patient is using enteral feeding tubes. It is necessary to transform solid oral medications into other forms for administration. Besides that, the occupational risk should be considered, and safety‐handling measures should be taken. This review aimed to investigate the available evidence regarding the use of immunosuppressive drugs through enteral feeding tubes, focusing on the administration technique, efficacy and treatment safety. Methods We performed an integrative review using the databases PubMed, LILACS, SciELO, Cochrane and Google Scholar, including papers published between 1997 and 2017 in Portuguese, English and Spanish. We excluded editorials, theoretical reflections, abstracts presented at events, dissertations, theses, monographs and studies with extemporaneous formulations administered only by the oral route. In addition, we investigated the references of the included papers, as well as pharmaceutical guides, books and package inserts of selected drugs for additional evidence. Information and recommendations found were analysed and classified according to the GRADE system. Results and discussion Fifty papers were identified, and 14 met the selection criteria. Among the assessed immunosuppressive drugs, we observed that tacrolimus, mycophenolic acid derivatives and azathioprine were the most studied, and they have more guided recommendations regarding their use through enteral feeding tubes. We noted the need for personal protective equipment for the conversion of the solid oral dosage forms, along with special caution during administration, due to occupational hazard. Other important factors identified were the position of the tube and interactions with the enteral nutrition, because they may compromise absorption, bioavailability and serum blood levels of immunosuppressive agents. However, the studies found have methodological limitations and poor quality, and this was taken into consideration during the classification of the evidence. What is new and conclusion The lack of information about the administration of immunosuppressive drugs through enteral feeding tubes should not be a limiting factor, considering the need for treatment of patients in these circumstances. Risks and benefits must be carefully analysed, and factors regarding compounding and administration through the enteral tube must be considered before beginning treatment. Hence, more primary studies are necessary for better fundamental clinical management.

A simple and fast alternative methodology using capillary zone electrophoresis (CZE) to analyze linezolid and its cationic photodegradation products in tablets has been developed. The separation was carried out on fused silica capillary and conducted using 100 mM formic acid (pH 3.0) and by applying 30 KV voltage. Detection was performed at UV 254 nm. The optimized method was validated in terms of linearity, limits of detection and quantification, precision (repeatability), stability studies (selectivity) and accuracy. Good linearity (8-20 mg L^-1) was obtained and the limit of detection was 0.95 mg L^-1. The greatest advantages of the CZE method were the rapid set-up of instrumentation and capillary equilibration, short analysis time (12 min), low running cost and low waste generation. The method showed good stability in determining linezolid submitted to degradation by light and to a climatic chamber and can be used as an alternative for evaluation in stability studies of linezolid in tablets, as well as for the analysis of the drug in raw materials and finished products.